National Institutes of Health (NIH)
Funding Opportunity Title
Nonhuman Primate Islet/Kidney Transplantation Tolerance (U01)
U01 Research Project – Cooperative Agreements
Reissue of RFA-AI-06-018
Funding Opportunity Announcement (FOA) Number
Catalog of Federal Domestic Assistance (CFDA) Number(s)
The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite new or renewal applications from single institutions and consortia of institutions to participate in the islet and kidney models portion of the Nonhuman Primate Transplantation Tolerance Cooperative Study Group (NHPCSG) program. The NHPCSG is a multi-center, cooperative program for research on nonhuman primate (NHP) models of kidney, islet, heart, and lung transplantation. The goals of the NHPCSG are to evaluate the preclinical safety and efficacy of existing and newly developed immune tolerance induction regimens and to elucidate the underlying mechanisms of the induction, maintenance, and/or loss of tolerance in these models. The long-range goal of this program is to develop and evaluate tolerance induction regimens that will result in enhanced long-term graft survival in clinical transplantation. The purpose of this FOA is to provide support for the NHP islet and kidney transplantation models portion of the NHPCSG program.
August 17, 2011
Open Date (Earliest Submission Date)
November 14, 2011
Letter of Intent Due Date
November 14, 2011
Application Due Date(s)
December 14, 2011 , by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)
Scientific Merit Review
Advisory Council Review
Earliest Start Date(s)
December 15, 2011
Due Dates for E.O. 12372
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The NIAID and NIDDK invite new or renewal applications from single institutions, or consortia of institutions, to participate in the islet and kidney models portion of the Nonhuman Primate Transplantation Tolerance Cooperative Study Group (NHPCSG) program. The overarching goals of the NHPCSG are to: (1) develop novel tolerance induction regimens; (2) evaluate the preclinical safety and efficacy of existing and newly developed candidate immune tolerance induction regimens; (3) develop and validate biomarkers for the induction, maintenance and/or loss of immune tolerance or for the prediction of graft rejection; and (4) elucidate the mechanisms underlying the induction, maintenance, and/or loss of tolerance in NHP allograft models of islet, kidney, heart, and lung transplantation. The currently funded islet and kidney model grants in the NHPCSG will expire in FY2012. This FOA solicits new or renewal applications for research projects focused only on NHP models of islet and/or kidney transplantation tolerance. All qualified investigators are invited to apply; prior funding under this program or other NIAID, NIDDK, or NIH mechanisms is not required.
This program will support single project (U01) cooperative agreements to achieve the goals listed above. These projects will be milestone-based and include the flexibility to redirect or replace research projects or specific aims during the funding period. Funding of a project beyond the first year will be contingent upon satisfactory progress in meeting negotiated milestones. In addition, the NIAID and NIDDK may re-budget individual U01 funds based on recommendations of the NHPCSG Steering Committee and/or based on NIAID/NIDDK assessment of availability of funds or awardee progress.
Organ transplantation is the preferred treatment for many end-stage organ diseases when other therapies have failed. However, long-term graft and patient survival remains less than optimal for all organ transplants despite significant advances that have led to one-year graft survival rates that approach or exceed 90% for most organs. In addition, life-long, global immunosuppressive therapy, while necessary for protection of the allograft from immune injury, is associated with significant morbidity including toxic effects that contribute to late graft failure. Advances in the induction of immune tolerance to the donor organ or tissue will provide valuable new therapeutic strategies, which, may eliminate the need for life-long, global immunosuppressive therapy, increase long-term graft survival and life expectancy, and improve health-related quality of life. NHP transplantation studies are a critical step in attaining these goals by providing key supporting data for the design of scientifically sound and ethically acceptable clinical trials. The value of the NHP transplantation model is due, in part, to the close approximation of the NHP immune system and physiology to those of humans.
The NIAID and NIDDK are strongly committed to developing safe and efficacious tolerance induction regimens that result in enhanced long-term graft survival and reduced morbidity in clinical transplantation. In 1998, the NIAID convened an Expert Panel for Research on Immune Tolerance that enthusiastically endorsed the conceptual framework, scope and timeliness of NIAID’s plan to accelerate research in this area, particularly with respect to clinical immune tolerance research programs. Two subsequent panels, the NIAID Expert Panel on Ethical Issues in Clinical Trials of Transplant Tolerance and the Expert Review Panel for NIAID's Extramural Transplantation Research Program, identified NHP tolerance research as an essential step to provide "...critical data on safety, toxicity and potential efficacy that cannot be obtained ethically in human clinical trials”. In 1999, in response to these recommendations, NIAID and NIDDK formally established a program in NHP models of allogeneic kidney and islet transplantation and expanded and renewed the program in subsequent years, with the last renewal in 2007 (RFA AI-06-018, http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-06-018.html ). In 2004, to further the goals of the NHPCSG, NIAID and NIDDK established a Discretionary Fund with the Special Statutory Funding Program for Type 1 Diabetes (T1DM) Research appropriation to capitalize on emerging opportunities through the funding of new pilot and feasibility studies using NHP islet and kidney models and to fund shared resources. Also in 2004, following the expansion in scope of human clinical trials supported by NIAID to include organs and tissues beyond kidney and islet transplantation, the scope of the NHPCSG was similarly expanded to include heart and lung transplantation models. This expansion reflects the need to improve outcomes of human heart and lung transplantation, as well as the view that graft rejection is an immunological disease with underlying mechanisms that may be shared across all organs and tissues, and the view that different organs and tissues may offer unique insights into various facets of immune tolerance induction and graft rejection. The heart and lung portion of the NHPCSG was most recently renewed in 2010 (RFA AI-09-041, http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-09-041.html ).
Beginning in 2000, due to decreasing availability and sharply rising costs of specific pathogen-free (SPF) Indian-origin rhesus macaques (Macaca mulatta) and cynomolgus macaques (Macaca fascicularis), NIAID established breeding colonies of these species to support the research efforts of the NHPCSG; however, NIAID does not guarantee the availability of animals to NHPCSG investigators. Over the long-term, in addition to providing a reliable supply of animals, this investment will provide the unique opportunity to have fully pedigreed and Major Histocompatibility Complex (MHC)-defined colonies, and the capacity to optimize the utility of the colonies through directed-breeding. Most significantly, this resource will enable researchers to design more powerful studies and better evaluate experimental outcomes through knowledge of the degrees of relatedness and MHC disparity or identity between donors and recipients.
The NHPCSG is a key component of the NIH mandate to translate basic discovery research to the clinic. NHPCSG funded investigators have made many advances over the years and provided key supporting data for numerous clinical trials, some of which are ongoing or currently under development. In 2005, two external scientific advisory panels (The NIDDK Meeting on the Special Statutory Funding Program for Type 1 Diabetes Research and NIH Expert Panel on Transplantation) reviewed the NHPCSG program. In 2009, the NIDDK convened an Ad Hoc Planning and Assessment Meeting on Preclinical Type 1 Diabetes Research, which also reviewed the progress of the NHPCGS. All external panels have concurred that continued support of this preclinical research program is a critical and high priority area of transplantation and T1DM research. Currently, the NHPCSG includes five U01 and two U19 awards on kidney and islet transplantation that will expire in FY 2012. Therefore, this FOA and the companion U19 FOA (RFA-AI-11-040) solicit new or renewal applications for NHP islet and kidney models of transplantation tolerance to continue this expiring portion of the NHPCSG program.
Research Objective and Scope
Research projects to be supported under this FOA are limited to NHP islet and/or kidney transplantation models. Specifically, this FOA calls for the use of any NHP species for allogeneic studies of islet and/or kidney transplantation. Applications must address components of the overarching goals of the NHPCSG as detailed below, including to: (1) develop novel tolerance induction regimens; (2) evaluate the preclinical safety and efficacy of existing and newly developed candidate immune tolerance induction regimens; (3) develop and validate biomarkers for the induction, maintenance and/or loss of immune tolerance or for the prediction of graft rejection; and (4) elucidate the mechanisms underlying the induction, maintenance, and/or loss of tolerance in NHP allograft models of islet and/or kidney transplantation.
While individual approaches may vary significantly, the research scope of the applications is restricted to, and must be clearly relevant to the following broad areas:
All U01 applications must contain at least one tolerogenic approach (one of the above) and must have at least one aim devoted to mechanisms and/or biomarker studies (one of the above) or have mechanistic and/or biomarker studies incorporated as integral parts of the research aims.
Note: Additional objectives related to the immune tolerogenic approach or immunologic mechanistic studies may be addressed, such as alternative transplantation sites for pancreatic islets, as long as the primary focus of the application meets the requirements as stated above.
In addition to the requirements above:
This FOA will NOT support:
Applications not meeting all of the requirements described above will be considered non-responsive to this FOA and will not be reviewed.
Explicit, detailed, and quantitative yearly Milestones should be included for each project for assessing progress and success; these annual Milestones will be used by NIAID program staff in assessing progress and recommending continued funding on an annual basis.
Based on an Awardee’s own evaluations, as well as assessment by the NIH Project Scientists and/or the NHPCSG Steering Committee, replacement or redirection of projects may be proposed at any time by the Project Director/Principal Investigator (PD/PI) for review by the NHPCSG Steering Committee and other experts, as required. The NHPCSG Steering Committee will provide recommendations regarding approval or disapproval of proposals for replacement or redirection to the NIAID and/or NIDDK Project Scientist. In addition, in order to maximize utilization of the NHPCSG program resources, the NIAID/NIDDK may re-budget individual U01 funds based on recommendations of the Steering Committee and/or based on NIAID/NIDDK assessment of availability of funds or progress toward yearly Milestones.
See Part 2.Section IV.2. “PHS 398 Research Plan Component: Research Strategy” and Part 2. Section VI.2 “Cooperative Agreement Terms and Conditions of Award: PD/PI Responsibilities, Areas of Joint Responsibilities”, below for more information regarding Milestones, redirection/replacement of projects, and continued funding.
Opportunities Pool Fund
To capitalize on emerging opportunities and sharing of resources consistent with the goals of the NHPCSG, opportunities funds of up to $1 million total costs (direct plus indirect costs) per year for the entire program may be provided after the cooperative agreement awards are made, depending on availability of funds. The funds, of up to $1 million total costs per year, includes the cost for the management of the Opportunities Pool Fund. Examples of activities supported by the current Opportunities Pool include development/maintenance of an internal website for NHPCSG activities, new pilot and feasibility research projects led by NHPCSG members, and research resource development projects. The Steering Committee establishes the goals, priorities, and evaluation criteria for the use of opportunity funds. Allocation of Opportunities Pool funds must be approved by majority vote of the NHPCSG Steering Committee. The current fund is supported by Special Statutory Funding Program for Type 1 Diabetes Research and therefore limits the focus of pilot and feasibility projects to islet and kidney models. All NHPCSG PDs/PIs will have the opportunity to compete for the Opportunities Pool funds.
After NHPCSG awards are made under this FOA, an awardee institution will be selected by NIAID and NIDDK from all awardees under this FOA and the companion FOA for U19 applications (RFA-AI-11-040) to administer the Opportunities Pool funds. All applicants shall submit budgets that solely reflect the needs of their individual applications and shall not include budgets for Opportunities Pool funding or activities, or management of Opportunities Pool funds. The Opportunities Pool is described under Part 2. Section VI.2, “Cooperative Agreement Terms and Conditions of Award: Areas of Joint Responsibility” below.
Opportunities Pool Fund Management
All applicants must include a letter from the PD/PI (or contact PD/PI if a multi-PI application) and the Institution’s Signing Official agreeing to take fiscal responsibility for the management of the Opportunities Pool funds, if chosen by NIAID and NIDDK to administer the fund. In addition, this letter of agreement shall state that at least six person months of administrative support will be available to manage the fund. The letter shall be included in the Letters of Support section of the application.
A detailed Opportunities Pool fund management plan and budget will be requested prior to award of the Opportunities Pool fund to the chosen awardee institution. The Management Plan and Budget shall not be prepared unless requested by NIAID/NIDDK. The requested budget will include at least six person months of administrative support to manage the fund. All management costs will come from the Opportunities Pool funds. Projects recommended by the Steering Committee and approved by the NIAID and NIDDK Project Scientists for Opportunities Pool support will be funded as subcontracts to the NHPCSG grant managing the Opportunities Pool, and thus generate the same additional responsibilities as any subcontract. Responsibilities of the Institution managing the Opportunities Pool fund will include:
The Management Plan shall include proposed measures and procedures for fund disbursement, and reporting and monitoring of the fund expenditures (e.g. time intervals for establishment and renewal of subcontracts and for payment of invoices, plans for handling subcontract administrative delays, and plans for handling overdue or missing invoices). Therefore, investigators are encouraged to work closely with their institutional grants and contracts office in the development of a Management Plan, if chosen by NIAID/NIDDK staff.
The NHPCSG Steering Committee serves as the governing board of this collaborative research program. Its actions and decisions are determined by majority vote. The Steering Committee responsibilities include identifying scientific opportunities, emerging needs, and impediments, and establishing and overseeing group collaborations. In addition, the Steering Committee oversees the scientific aspects of the Opportunities Pool Fund, including establishing the goals, priorities, and evaluation criteria for the use of discretionary funds. In addition, the Steering Committee will evaluate the progress and direction of individual awards and make recommendations to the NIAID and NIDDK regarding the continuation, replacement, redirection, or discontinuation of U award projects on an ongoing basis.
Each U01 will have one vote, on the existing NHPCSG Steering Committee. The voting members are one PD/PI for each award. Additional PDs/PIs of a multiple PD/PI award will be non-voting members. For additional information, see Steering Committee below under Areas of Joint Responsibility. For more information about the Steering Committee composition and responsibilities, please see Section VI.2. “Cooperative Agreement Terms and Conditions of Award: Areas of Joint Responsibilities”, below.
Nonhuman Primate Resources
The NIAID owns and maintains specific pathogen-free (SPF) breeding colonies of cynomolgus and rhesus macaques to help support the studies funded through the NHPCSG. Provision of NHPs from the NIAID breeding colonies to NHPCSG investigators is determined by availability, scientific priority, and equitability. The NIAID Project Scientist makes final decisions regarding allocation of these resources. The Steering Committee provides scientific advice and recommendations to the NIAID regarding breeding strategies, testing, and other considerations to optimize the long-range value of these resources to the research community.
The applicants should identify their own supply of animals to complete their proposed studies and include the cost of the animals in their proposed budget. NIAID does not guarantee availability of animals to NHPCSG investigators, particularly when special NHP requirements of a study are limiting, e.g. full or half sibling pairs that are MHC “haplotype” matched. In addition, two of the three colonies established for the NHPCSG are young and not expected to meet the complete needs of the NHPCG for at least several years after awards are made under this FOA. (See Section IV. 2. “Application and Submission Information: R&R Budget Component, Purchase of Animals”, below.)
The budget must request funds for the PD/PI or PDs/PIs, if a multi-PD/PI application, to attend one Steering Committee meeting per year to be held in the Bethesda, Maryland area.
Application Types Allowed
The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards
NIAID and NIDDK anticipate that approximately $7.9 million in total costs (direct plus indirect costs) will be available in FY 2012 to fund approximately five to seven new or renewal awards, including awards made under the companion FOA (RFA-AI-11-040) for U19 applications. Up to approximately $1.0 million in total costs of the $7.9 million may be used to fund and manage an Opportunities Pool Fund.
A portion of the funding for this FOA and the companion FOA (RFA-AI-11-040), including the Opportunities Pool Fund, is provided by the Special Statutory Funding Program for Type 1 Diabetes Research, which is currently authorized through FY 2013. In the event this Special Statutory Funding Program is not reauthorized for FY 2014 – FY 2016, grant projects supported by the Special Statutory Funding Program may not be funded beyond FY 2013. Alternatively, programmatic funding reductions may be made across all or a portion of NHPCSG grants to compensate for a possible cessation of the Special Statutory Funding Program.
As a guideline, the approximate amount of funding in direct costs per NHPCSG award in the current funding year is $0.36 to $0.57 million for U01 awards. Applicants may have valid reasons for deviating from this range, and are encouraged to discuss such deviations with the Scientific/Research Contact listed in Section VII.1 below.
Award Project Period
An applicant may request a project period of up to five years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Higher Education Institutions
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
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Priti Mehrotra, M.Sc., Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
For Express Couriers: 20817-1824
Phone: 301-435-9369, 301-496-2550
The forms package associated with this FOA includes all applicable components, mandatory 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.
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
· Reagent Availability
Within the Resources section of the application, and not part of the 12 page Research Strategy, provide the source of, and timelines for, the availability or expected availability of all critical non-commercially available reagents or therapeutic agents proposed.
· Purchase of Animals
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
· Treatment Protocols, Objectives, and Yearly Milestones
Within the 12 page Research Strategy page limit, applicants should include a synopsis and a treatment diagram/timeline detailing the proposed treatment protocol(s) and clearly defined experimental endpoints and; a conceptual framework providing rationale for the proposed approach to tolerance induction and the relevance to human transplantation.
In addition, and also within the 12 page Research Strategy page limit, applicants should include clearly stated interim and long-term objectives to be achieved during the project, with impediments and/or critical decision points that could require a revision in the work plan. Include a detailed timeline with the critical decision points notated for the proposed studies.
At the end of the Research Strategy and within the 12 page limit, applicants should provide detailed, explicit and, where applicable, quantitative Milestones that should be achieved each year of the Project. The peer review panel will evaluate and provide comments on these yearly Milestones, however the Milestones are subject to negotiation with the NIAID/NIDDK Project Officer prior to and/or after award. In addition, Milestones may be evaluated by the NHPCSG Steering Committee and recommendations for modifications provided to the NIAID/NIDDK Project Officer. For additional information see Part 2. Section I. “Funding Opportunity Description: Research Objective and Scope Milestones”, above and Part 2. Section VI.2. “Cooperative Agreement Terms and Conditions of Award: PD(s)/PI(s) Responsibilities and Areas of Joint Responsibilities”, below.
Note: The Vertebrate Animal Section is not part of the Research Strategy (12 page limit).
Letters of Support
All applicants must include a letter from the PD/PI, or contact PD/PI if a multi-PD/PI application, and the Institution’s Signing Official agreeing to take responsibility for the management of the Opportunities Pool funds if chosen by NIAID to administer the fund. In addition, this letter of agreement shall state that at least six person months of administrative support will be available to manage the fund. The letter shall be an attachment to the application. See Part 2. Section I “Funding Opportunity Description: Opportunities Fund Management”, above.
All applicants must provide letters of commitment from reagent sources, where appropriate, documenting the availability, quantity, and anticipated timelines for supplying the reagents. These letters should be submitted as an attachment to the proposal.
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, with the following modifications:
Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via 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.
Applicants are responsible for viewing their application 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 SF 424 (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.
All PD/PIs must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(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.
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 Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
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.
Reviewers will provide an overall impact/priority 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? 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? Is the project as a whole significant? What is the likelihood that the results of the proposed studies will be translated into or contribute to new approaches and knowledge that are relevant to future studies in NHPs and human transplantation?
Are the PD/PIs, 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? Is the level of effort of the PD/PI and/or multiple PDs/PIs sufficient to ensure success of the program? Are there appropriate expertise and sufficient effort of NHP transplantation in the key personnel to ensure the success of the program? Are there sufficient effort and expertise of basic transplant investigators and/or immunologists to ensure success of the program?
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?
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
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
Are reagents or therapeutics needed for the conduct of the study available or is it reasonable to assume they will be developed or become available in the proposed time-frame? Are the proposed approaches timely and justified for NHP research? Are the approaches relevant to translation into humans and/or will what is learned from the approach in the NHP model provide insight that may prove informative or beneficial to future studies or mechanisms of graft rejection/acceptance or tolerance? Are the yearly Milestones and timelines adequate, appropriate, and reasonably attainable? Are the levels of details provided sufficient?
Is the justification for the numbers of animals (or small numbers of animals, if applicable) reasonable? Are the statistical considerations of the proposed experiments and the proposed conclusions that may be reached reasonable and appropriate? Are the acquisition and preparation of the solid organs, tissues or cells to be used in the studies and the proposed methods, source, and number of NHP samplings/biopsies required appropriate?
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? Are appropriate and sufficient animal housing and care facilities available to the investigators to carry out the proposed work?
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/priority score, but will not give separate scores for these items.
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 Human Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
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.
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.
For Renewals, the committee will consider the progress made in the last funding period.
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/priority score.
Applications from Foreign Organizations
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases (NIAID), in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
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 Advisory Council or Board. The following will be considered in making funding decisions:
Timely availability of critical reagents and resources.
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
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.
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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.
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
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 responsibilities as follows:
The PD/PI is responsible for defining the research plan and goals within the guidelines of this FOA; setting project milestones and timelines to achieve the proposed goals; overseeing/performing the scientific activities; ensuring successful completion of yearly Milestones within the timeframe and budget proposed; cooperating with NIAID/NIDDK programmatic, technical, and administrative staff; and administratively managing the U01.
Each U01 will have one vote, on the existing NHPCSG Steering Committee. The voting members are one PD/PI for each award. Additional PDs/PIs of a multiple PD/PI award will be non-voting members. For additional information, see Steering Committee below under Areas of Joint Responsibility.
The PDs/PIs will participate in all Steering Committee activities, attend Steering Committee meetings, and will follow the policies and procedures developed by the Steering Committee. Other investigators of awards made under the U01 or U19 solicitations may serve as non-voting members as determined by the Steering Committee.
NIAID and NIDDK intend to support the peer-reviewed studies/specific aims proposed in the grants awarded under this FOA; however, the awards are milestone-based. Yearly Milestones may be negotiated and modified prior to award or post-award, based on peer review and/or NIH Project Scientist assessment of the proposed yearly Milestones. In addition, before the end of the first year of award the PD(s)/PI(s) will present an overview of their program and yearly Milestones to the NHPCSG Steering Committee for assessment. Under special circumstances (e.g. duplicative or overlapping specific aims between two awardees) changes to the peer-reviewed studies or yearly Milestones may be recommended by the Steering Committee in the first year of award. It is also recognized that project goals may require revision and re-negotiation during the course of the project period. When yearly Milestones are not met, a critical reagent is not available, or results indicate that continuation of the peer-reviewed aims is not warranted, the NHPCSG Steering Committee and other experts, as required, may be asked for recommendations. The Steering Committee and other experts, as required, will review any PD/PI proposals for replacement or redirection of projects or for significant modification of yearly Milestones and provide recommendations for approval or disapproval to the NIAID/NIDDK. In addition, in order to maximize utilization of NHPCSG program resources, the NIAID/NIDDK may re-budget individual U01 funds based on recommendations of the Steering Committee and/or based on NIAID/NIDDK assessment of progress or availability of funds. NIAID and NIDDK reserve the right to terminate or curtail a study (or any individual U01/U19 grant or U19 project award) in the event of a substantial shortfall in study Milestones or other major breach of the approved project.
The PD/PI, upon acceptance of an award, agrees to participate in all collaborative studies, including those that involve collaborations with biotechnology and pharmaceutical companies, as specified by the Steering Committee or that may be requested by NIAID. This policy is in keeping with the terms and conditions of the cooperative agreement mechanism.
The PD/PI will ensure that all NHPs obtained from the NIAID breeding colonies are used only for the expressed purposes of the individual Cooperative Agreements funded through this FOA or proposals approved by the Steering Committee.
After grant award, one U01 or U19 (from companion RFA-AI-11-040 awardee institution will be selected by the NIAID/NIDDK to manage the Opportunities Pool Fund for the entire NHPCSG. Projects recommended by the Steering Committee and approved by the NIAID/NIDDK Project Scientist for Opportunities Pool support will be funded as subcontracts to the NHPCSG grant institution managing the Opportunities Pool fund, and thus generate the same additional responsibilities as any subcontract. Responsibilities of the institution managing the Opportunities Pool fund will include:
The selected awardee institution for management of this Fund will be requested to provide a detailed Opportunities Pool Management Plan and budget prior to award of the Opportunities Pool Fund. In addition to the responsibilities listed above, the Plan shall also include proposed measures and procedures for disbursement, reporting and monitoring of the fund expenditures (e.g. time intervals for establishment and renewal of subcontracts and for payment of invoices, plans for handling subcontract administrative delays, and plans for handling overdue or missing invoices). This plan will become part of the Consortium Agreement for the Institution(s) selected to Manage the Fund. For additional information see Part 2, Section I “Funding Opportunity Description, Research Scope, Opportunities Pool Fund Management”, above.
NHPCSG investigators, including collaborators with effort on the U01 award, are eligible to apply for future Opportunities Pool awards. These awards are administered by the Steering Committee as part of the NHPCSG program. The PD/PI of each U01 will be responsible for ensuring that all Opportunities Pool awards adhere to the rules and guidelines of the NHPCSG Steering Committee.
The PD/PI will be responsible for the timely submission for publication of manuscripts (co)authored by members of the grant and supported in part or in total under this Agreement and adherence to all aspects of the collaborative group’s Publications Policy to be determined by the NHPCSG Steering Committee. At a minimum, all manuscripts resulting from work done in this consortium will be submitted to the NIAID/NIDDK Project Scientist no later than at the time of submission for publication so that an up-to-date summary of the cooperative program accomplishments can be maintained and NIAID/NIDDK press releases can be prepared, if applicable. Publications or oral presentations of work performed under this Agreement are the responsibility of the PD/PI and appropriate Project Leaders and require acknowledgement of NIAID support.
Awardees are expected to make new information and materials, including research samples, tools, materials, methods, reagents, and data developed under the NHPCSG grants known and available to the broader research community and other members of this program in a timely manner through publications, presentations, web announcements, submission to public resources or databases, and reports to the NIAID and/or NHPCSG Steering Committee, subject to the rights described below.
Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
NIH Staff Responsibilities
NIAID and NIDDK (NIH) program officials will also serve as the Project Scientists and will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
The NIH Project Scientists will serve as facilitators of NHPCSG activities and scientific endeavors and provide advice, technical assistance, and guidance on technical and management issues, such as reviewing progress and subcommittee requirements. The Project Scientists will serve as liaisons/facilitators in identifying potential sources of reagents or other resources, and identifying potential collaborations to further the goals of the NHPCSG. The Project Scientists will also serve as a resource of scientific and policy information related to the goals of the awardee’s research. However, the roles of the Project Scientists will be to facilitate and not to direct the NHPCSG activities.
The NIAID Project Scientist approves the distribution of NHPs from the NIAID breeding colonies for the individual research projects, based on availability and number of animals proposed in the peer-reviewed studies.
The NIH Project Scientists will serve as non-voting members of the Steering Committee. The NIAID Project Scientist will assist with scheduling the meetings and teleconferences of the Steering Committee and subcommittees, and ensure coordination of Steering Committee activities and implementation of its recommendations, decisions, and policies. It is anticipated that decisions in most Steering Committee activities will be reached by consensus and the NIH Project Scientists will be given the opportunity to offer input into the process, but the manner of reaching this consensus and the primary decision-making responsibility will rest with the Steering Committee, except where stated in this FOA.
As detailed under PD/PI Responsibilities above, NIAID and NIDDK intend to support the peer-reviewed studies/specific aims proposed in the awarded grant applications. However, the awards are milestone-based and the NHPCSG program includes the flexibility for the NIH Project Scientists to redirect or replace research projects during the funding period. In addition, in order to maximize utilization of NHPCGS program resources, the NIH Project Scientists may re-budget individual U01 funds based on recommendations of the Steering Committee and/or based on NIAID/NIDDK assessment of availability of funds and grant progress. NIAID/NIDDK reserve the right to terminate or curtail a study (or any individual U01/U19 grant or U19 project award) in the event of a substantial shortfall in study milestones or other major breach of the approved project.
Additionally, a NIAID and/or NIDDK Program Officer/Director will be responsible for the normal scientific and programmatic stewardship of the awards. The assigned NIH Program Officer/Director may also serve as the Project Scientist. This stewardship role will include monitoring program progress and approving changes. The Government, via the NIH Program Officers/Director, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. NIAID and NIDDK staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards.
Areas of Joint Responsibilities
The NHPCSG Steering Committee will serve as the governing board for awardees of this program. As mentioned in the PD/PI Responsibilities section, each U01 will have one vote. In addition, selected scientists other than the awardees may serve as voting members when additional expertise is required for committee breadth and balance, to be determined by majority vote of the Steering Committee. A Chairperson will be elected by majority vote from among non-government voting members.
The NHPCSG Steering Committee can appoint additional non-voting members by majority vote. In addition, the NIH Project Scientists may appoint two external scientists as an Advisory Working Group (acting in a scientific advisory capacity to NIAID and NIDDK) to the Steering Committee as non-voting members. The NIH Project Scientists will also serve as non-voting members.
The NIAID Project Scientist will actively participate with the Chair in developing Steering Committee meeting agendas. The NHPCSG Steering Committee will meet in person at least annually, usually in the Bethesda, MD area. Additional meetings will be held via teleconferences. Proposed budgets should include travel costs for the all voting members of the Steering Committee to attend these meetings, and additional PDs/PIs if multiple PDs/PIs. Each Steering Committee member will be expected to participate in all meetings and activities, e.g., conference calls and special subcommittees as required.
The NHPCSG Steering Committee will oversee the Opportunities Pool Fund for the consortium, including establishment of protocols, policies, and subcommittees, as needed, for the Opportunities Pool solicitation, receipt, review, development, evaluation, and approval of feasibility, pilot, resource development, or collaborative projects or potential resource sharing opportunities and other collaborative needs. The Steering Committee will also determine website or additional professional and administrative staffing needs beyond the administrative support provided as part of the requirements to manage the Opportunities Pool budget and activities (e.g. for review activities or Information Technology needs). In addition, the NHPCSG Steering Committee, or a designated subcommittee, will be responsible for an annual report of progress of projects and other activities funded by the Opportunities Pool program, including outcomes of all completed projects. This Steering Committee activity may be coordinated through the institution responsible for the Opportunities Pool fund management, as part of the institution’s annual progress report.
The Steering Committee shall draft a NHPCSG Goals and Action Plan for the funding period by the end of the first funding year. This Action Plan shall include the organization of at least one workshop to be held during the funding period. The NIH Project Scientists will participate and assist in the organization and planning of the workshop and the NIAID/NIDDK will provide support for this meeting. The workshop should include participants from outside the NHPCSG to further its goals in building collaborations and engaging the broader research community.
Within three months of award all voting members of the NHPCSG Steering Committee will participate in a conference call (if a face-to-face meeting is not possible prior to this time) to develop a plan for the evaluation of all grants awarded under this FOA during the first year of award; to organize drafting of a NHPCSG Goals and Action Plan for the funding period; to review the Opportunities Pool program budget, needs, rules and policies, and to revise these as required; to assess website needs; and to address other Cooperative Group needs and mandates. The NIH Project Scientists will also participate in this meeting.
The NHPCSG Steering Committee or a designated subcommittee will prepare a cumulative group progress report or ad hoc reports, as required, on Consortium activities, when requested by the NIH Project Scientists. At the completion of the second or third year of funding, a progress report will be required that contains, at a minimum, the following information: project overviews; cumulative progress of ongoing and newly-initiated projects; manuscripts published, in press, and in preparation; a list of presentations at regional, national, and international meetings; Opportunities Pool program progress and activities; other NHPCSG activities; and future plans. The reports will be submitted to the NIAID and NIDDK Project Scientists no later than four months after the NIH Project Scientists requests a report, or a time agreed upon by the NIH Project Scientists and the Steering Committee Chair.
In order to efficiently utilize research resources and rapidly exchange scientific information to promote the NHPCSG objectives, it is anticipated that cooperation or opportunities to collaborate with other NIH funded programs, including clinical trials programs, will be initiated in future years and will be coordinated and facilitated by the NIH Project Scientists.
Other Steering Committee responsibilities include the following:
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 Steering Committee 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.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually 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.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
eRA Commons Help Desk(Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Kristy Kraemer, Ph.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
Room 6405, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Michael C. Appel, Ph.D.
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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6707 Democracy Boulevard
Bethesda, MD 20892-5460
Priti Mehrotra, M.Sc., Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
For Express Couriers: 20817-1824
Phone: 301-435-9369, 301-496-2550
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
Room 2108, MSC-7614
6700B Rockledge Drive
Bethesda, Maryland 20892-7614
Express Mail Zip: 20817
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
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