Required Application Instructions

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

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

The purpose of this funding opportunity announcement (FOA) on Innovative Research in Cancer Nanotechnology (IRCN) is to expand the fundamental understanding of the processes pertinent to the use of nanotechnology in cancer. Projects supported by the IRCN initiative should be multi-disciplinary and generate new fundamental knowledge associated with the development of nanotechnology-based solutions to major problems in cancer-biology and/or oncology. The outcomes of IRCN-supported projects should inspire and aid the ultimate development of innovative, clinically relevant nanotechnology solutions for cancer (although prospective clinical translation of the IRCN findings remains beyond the scope of this FOA).

The IRCN initiative is an integral part of the NCI Alliance for Nanotechnology in Cancer program. In addition to IRCN U01 projects supported by this FOA, the Alliance will consist of the Centers of Cancer Nanotechnology Excellence (CCNEs, supported by U54 RFA-CA-14-013) and T32 training programs (supported through PA-14-015).

Nanotechnology in the context of this FOA. To be appropriate for this FOA, the proposed nanotechnology approaches, materials, devices, and technologies should be clearly distinguishable from their classical counterparts and must meet the following criteria:

• Functional components of devices or base materials either fabricated, assembled, or synthesized, must be at dimensions of 300 nm or less;
• Materials used and/or proposed to be developed must be either synthetic or biologically-based materials that are engineered to provide novel properties or modified functions due to their controlled assembly or synthesis at the nanoscale.

This FOA will NOT support projects that:

• Propose only the use of naturally-occurring materials (e.g., polysaccharides, proteins, viruses) that are not specifically engineered or modified for the intended function;
• Propose the use of nanotechnology-based devices for DNA sequencing;
• Involve clinical trials or in vivo studies in human subjects;
• Focus on nanotechnology solutions for AIDS/HIV even in the context of cancer.

Potential of nanotechnology in oncology. Nanotechnology has the potential to overcome various existing barriers in cancer research and care and offer previously unattainable benefits to cancer care. Nanotechnology can lead to a generation of new diagnostic and therapeutic approaches with the potential to improve cancer care outcomes. Nanotechnology may also drive advances in other aspects of clinical oncology and cancer research. These potential benefits are being explored by NCI through support of multi-disciplinary research under the umbrella of the NCI Alliance for Nanotechnology in Cancer (http://nano.cancer.gov, also referred to in this FOA as the "Alliance"). The Alliance was founded in 2004 and is committed to developing and applying nanotechnology to new cancer care applications.

NCI intends to continue support for research in three broad areas of nanotechnology-based cancer care applications: (1) early diagnosis using in vitro assays and devices or in vivo imaging techniques; (2) multifunctional nano-therapeutics, including nanoparticle-driven immunotherapies; and (3) devices and techniques for cancer prevention and control. Specific research directions, priorities, and needs for the reissuance of the Alliance program were identified by seeking feedback from the scientific community, which included:

• a Strategic Workshop on Cancer Nanotechnology held in June 2013 (the workshop's report can be found at http://www.ncbi.nlm.nih.gov/pubmed/24413533);
• an interactive website (https://nanocancer.ideascale.com); and
• a Request for Information (NOT-CA-13-017).

The participants of the Strategic Workshop clinical oncologists, cancer researchers, and technologists expect that further progress in the field will move along two parallel tracks: (1) on-going translation of maturing technologies to the clinical environment and (2) the development of new tools and techniques in the research arena. The community expects that, in the future, nanotechnology will become a core component of research and translational programs at all leading cancer research institutions and a significant part of comprehensive cancer care.

The continued Alliance program will consist of the following initiatives:

Centers of Cancer Nanotechnology Excellence (CCNEs). CCNE teams (funded through U54 mechanism, RFA-CA-14-013) will be required to pursue vigorous development of technologies that have practical clinical applications, up to and including the pre-clinical stage. These efforts should be integrated with research of a discovery nature and should contribute to the understanding of clinically relevant cancer problems.

Innovative Research in Cancer Nanotechnology (IRCN, covered by this FOA) Awards. IRCN awards will support smaller, well-defined projects aimed mainly at discovery research. Their focus will be on developing further understanding of nanomaterial interactions with biological systems and the mechanisms of nanoparticle delivery to the desirable and intended cancer targets in vivo.

Interdisciplinary Nanotechnology Training and Career Development. To enhance multidisciplinary training, T32 training programs dedicated to cancer nanotechnology will be supported through the Parent T32 Announcement PA-14-015. As defined in NOT-CA-14-035, the NCI will participate in this NRSA T32 program to further accelerate and intensify the development of a workforce highly skilled in nanotechnology research with medical applications.

General Expectations for IRCN Projects. IRCN awards are expected to produce advances in applying nanotechnology to cancer research: Significant advances are expected in the overall capacity to employ nanotechnology to understand neoplastic diseases. Each proposed IRCN project is expected to generate new fundamental knowledge aiding the development of nanotechnology-based solutions to major problems in cancer-biology and/or oncology. These projects should emphasize fundamental understanding of nanomaterial interactions with biological systems, including aspects relevant to the delivery of nanoparticles to desired and intended cancer targets in vivo.

Possible Research Directions. Examples of appropriate research areas are listed below. These examples are not meant to be comprehensive. Additional directions are also encouraged, providing they are consistent with the general expectations statedabove. For further details, see Section IV.2. Content and Form of Application Submission.

• Development of next generation nanoparticles;
• Understanding nanoparticle delivery mechanisms and implications of systemic distribution;
• Techniques and tools to overcome failure of therapy;
• Tools and devices aimed specifically at monitoring the tumor microenvironment;
• Technologies suitable for biomarker discovery and screening;
• Technologies for cancer molecular targeting, discovery, and validation;
• Devices and tools capable of penetrating cellular and/or physiological barriers;
• Integration of modeling and simulation approaches to guide rational nanomaterials design.

Tumor Types. All IRCN applicants are expected to concentrate their proposed efforts on one or two rationally selected tumor types. For this FOA, a "tumor type" refers to either tumors of a specific tissue of origin or tumors with critical abnormalities in a particular molecular pathway(s) shared in cancers arising from a variety of tissues.

The Alliance will be governed by the Alliance Coordination and Governance Committee (CGC). The CGC will oversee and coordinate the activities of all CCNEs, IRCN awards, and training programs. Details on the composition and functions of CGC are provided in Section VI. Award Administration Information, Terms and Conditions of Cooperative Agreement, Areas of Joint Responsibility .

As the efficiency of the funded research is an increasing priority for NCI, IRCN awardees will be required to participate in an external evaluation process of the Alliance initiative coordinated by NCI Program Staff. Outcomes to be assessed will include: peer-reviewed publications, patent disclosures and filings, technology commercialization, technologies brought to clinical trials, educational and outreach programs, effectiveness of collaborative research development model, and other factors.

The purpose of the evaluation process is to monitor and assess the performance of the IRCN awards in achieving the goals of this FOA. This process includes evaluating the quality and innovation of the research conducted in the IRCN awards, as well as assessing other critical indicators, including collaborations, and resource and data sharing across the Alliance. Criteria for the evaluation component will be developed by NCI Program Staff in partnership with the Alliance Coordinating and Governance Committee (CGC) and other advisory committees of the program (as described in Section VI).

Applicants are encouraged to consider using, as appropriate, various relevant NCI-supported resources described below.

• Nanomaterials characterization. The NCI recognizes that further development of nanotechnologies for oncology purposes will benefit greatly from a concerted and coordinated effort to characterize the wide range of nanoscale materials and devices. The collection of this information will chart the common baseline and scientific data that would inform the research and development (R&D) community and define clinical and commercial pathways for integration of nanoscale diagnostics, imaging agents, and therapeutics. The NCI s Nanotechnology Characterization Laboratory (NCL; http://ncl.cancer.gov/) will provide infrastructure support towards the uniform and consolidated characterization of these materials and devices and thus will aid the translation of nanotechnology-derived cancer therapeutics and diagnostics from the advanced discovery-phase to clinical environment.
• Nanotechnology-related informatics. The NCI Center for Biomedical Informatics and Information Technology (http://cbiit.nci.nih.gov/) sponsors the cancer Nanotechnology Laboratory data portal (caNanoLab; https://cananolab.nci.nih.gov/caNanoLab/) and the National Cancer Informatics Program (NCIP) Nanotechnology Working Group (https://wiki.nci.nih.gov/display/ICR/Nanotechnology+Working+Group). caNanoLab is designed to enable sharing of nanomaterials data and to expedite and validate the use of nanoparticles in biomedicine. It provides support for the annotation and secure sharing of cancer-relevant nanomaterials with characterizations resulting from physico-chemical, in vitro, and in vivo assays. The NCIP Nanotechnology Working Group was established for researchers with a specific interest in informatics and computational approaches to nanotechnology. In addition to these efforts, NCI supports the Nanomaterial Registry (https://www.nanomaterialregistry.org/), which archives research data on nanomaterials and their biological and environmental implications from a broad collection of publically available nanomaterial resources.
• Animal models. NCI supports a broad spectrum of animal facility experimental resources (Laboratory Animal Science Program [LASP]: http://ncifrederick.cancer.gov/rtp/lasp/intra/lasp.asp and operates the Center for Advanced Preclinical Research [CAPR]: http://frederick.cancer.gov/Partnerships/Capr.aspx) that can conduct independent preclinical assessment of nanomaterials in vivo in a variety of predictive xenograft and genetically engineered mouse models, as well as syngeneic genetically engineered mouse-derived allografts.
• Other NCI research resources. IRCN applicants are encouraged to consider establishing partnerships with other groups, and divisions and programs within NCI that may benefit the IRCN's goals. For example, the awardees should take advantage of appropriate opportunities to work with The Cancer Genome Atlas (TCGA; http://cancergenome.nih.gov/), Cancer Target Discovery and Development (CTD2; http://ocg.cancer.gov/programs/ctd2) Network, Early Detection Research Network (EDRN; http://edrn.nci.nih.gov/), Clinical Proteomic Tumor Analysis Consortium (CPTAC; http://proteomics.cancer.gov/programs/cptacnetwork), and the Cancer Diagnosis Program (CDP; http://www.cancerdiagnosis.nci.nih.gov/).

Beyond the Alliance and other NCI resources, IRCN applicants are also encouraged to take advantage of the range of additional existing opportunities in nanotechnology research and development through partnerships with other Federal agencies, such as the National Science Foundation (NSF); http://www.nsf.gov and the Department of Energy (DOE);http://science.energy.gov/bes/research/national-nanotechnology. The NSF and DOE programs are components of the National Nanotechnology Initiative (http://www.nano.gov/), a multi-agency framework of nanotechnology research that may serve as a resource for applicants to this FOA.

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

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

• State Governments
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

NOTE: PDs/PIs designated on a U54 application in response to the CCNE RFA-CA-14-013 are NOT eligible to apply as PDs/PIs for the U01 IRCN award under this FOA for the first due date in October 2014. However, these individuals may serve as other key personnel on the U01 applications under this FOA.

Given the need for integration of multi-disciplinary efforts in IRCN projects, applicants are encouraged to take advantage of the multiple PD/PI option with one PD/PI representing biology or oncology fields and another PD/PI representing the fields of chemistry, physics, or engineering.

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:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

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

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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 with the following modifications:

Facilities and Other Resources:

Under a heading "Nanomaterials Characterization and Animal Resources", provide a description of nanomaterials fabrication/synthesis and characterization facilities, including access to animal studies and the capacity to link to the capabilities of NCI’s Nanotechnology Characterization Laboratory (NCL) (http://ncl.cancer.gov/).

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.

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

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

Specific Aims: Outline the specific goals of the project, including major milestones.

Research Strategy: The proposed project description must consist of the standard sub-sections: Significance, Innovation, and Approach and an additional "Milestones" sub-section (described below).

Project Scope and Emphasis. The proposed project should emphasize fundamental understanding of mechanisms associated with the use of nanotechnology in solving a cancer-relevant problem. Under the Significance sub-section, provide rationale for why the proposed project is expected to produce a significant body of fundamental, mechanistic knowledge relevant to the interactions of nanomaterials with biological systems and/or the mechanisms of nanomaterial delivery to the intended targets in vivo. Indicate also in the Significance sub-section whether the anticipated advances have the potential to significantly benefit the broader field of biomedical nanotechnology applications (beyond cancer).

Well Developed, Rigorous Project. Proposed projects are expected to be well developed conceptually and, in general, well supported by appropriate preliminary data from investigators laboratories, similar to typical R01 investigator-initiated projects. However, it is realized that original research data may be incomplete for some aspects of highly innovative nanotechnology projects, especially in areas that are at an earlier stage of development (e.g., studies of delivery mechanisms, nanosystems that exploit alternative delivery routes). Projects with gaps in preliminary data may still be appropriate, provided they are conceptually highly innovative and rigorously integrate to the extent possible the available incomplete information for a given area from various sources.

Potential for Innovation- proposed nanotechnology solution versus other options. In the Innovation sub-section, provide comparison of the proposed nanotechnology approach to available or possible classical approaches/options and/or currently used nanotechnology solutions. Discuss how the problem is approached at present and the limitations of current solutions, and how the proposed nanotechnology is expected to overcome these limitations. Summarize the key advantages and innovative aspects of the proposed technology, solution, etc. over other options. Generally, this comparison should be based on actual data (either investigators own preliminary data or literature data). In justified situations, however, theoretical considerations may also be used.

Selection of Tumor Types. The project may focus, as appropriate and justified, on one or two rationally selected tumor types or types of abnormalities. In selecting specific tumor types, IRCN applicants are strongly encouraged to take advantage of available resources with catalogs of clinical tumors that have been comprehensively characterized at the molecular genetics level (e.g., by programs such as The Cancer Genome Atlas (TCGA), http://cancergenome.nih.gov/, Therapeutically Applicable Research to Generate Effective Treatments (TARGET), http://ocg.cancer.gov/programs/target, and Cancer Genome Characterization Initiative (CGCI), http://ocg.cancer.gov/programs/cgci).

Selection of Animal Tumor Models. Describe the animal tumor models that you plan to use in the proposed studies. To drive data comparability, the Alliance Coordination and Governance Committee (CGC)may suggest well-characterized and reproducible animal models, and experimental design, to be used for particular cancer types based on best practice guidelines and the input of Alliance participants.

Possible Research Directions. Examples of appropriate research directions are listed below. The list below is not meant to be comprehensive and additional directions/topics are also encouraged, providing they fit into the overall goals of IRCN and conform to other requirements. Moreover, the listed examples are NOT mutually exclusive and are NOT meant to confine the scope of a project. Various directions may be combined into a single project, if appropriate.

• Development of next generation nanoparticles including, but not limited to: bioresponsive and bioactivatable nanomaterials; nanoparticles/nanosystems that can be triggered externally (e.g., by light, heat, electromagnetic field, etc.) or by physiological triggers causing payload activation and/or release of active agents (e.g., pH, enzymes); and nanoparticles/nanosystems that exploit alternative delivery routes such as oral and nasal.
• Detailed studies and understanding of delivery mechanisms, including, but not limited to:
• Factors affecting endosomal escape of nanoparticles;
• Enhanced Permeability and Retention (EPR) effect;
• comparison of passive vs active targeting;
• evidence of nanomaterial penetration through biological barriers and target organ accumulation with minimal off-target effects.
• Techniques and tools to overcome failure of therapy, including, but not limited to:
• acquired drug resistance
• presence of circulating tumor cells (CTCs)
• the establishment of metastatic spread;
• Tools and devices aimed specifically at monitoring of the tumor microenvironment, its heterogeneity, and its changes during tumor progression;
• Technologies for biomarker discovery and screening;
• Technologies for cancer molecular targeting, discovery, and validation (e.g., targeting of signaling pathway members such as mutant KRAS or mTOR);
• Devices and tools capable of penetrating cellular barriers that may limit accessibility to intended targets (e.g., blood-brain-barrier, stroma);
• Integration of modeling and simulation approaches that incorporate characterization data on interactions of nanoparticles with the physiological environment to guide rational nanomaterial design.

Note: Proposed projects may use an appropriate combination of the following types of models in silico theoretical modeling of human systems, sub-cellular systems and established cell lines in vitro, ex vivo clinical biospecimens, and/or in vivo animal models.

Future Collaborations. In the Approach sub-section, identify the areas of research in which you may seek collaborations in the future to expand and complement your proposed efforts. Note that, if possible and appropriate, Alliance awardees will be encouraged and expected to engage in such mutually beneficial collaborations.

Milestones. This sub-section is required for all applications. All applicants must describe here a set of discrete benchmarks that will allow unequivocal determination of the progress made towards the goals of the project. Milestones should be scientifically justified and well defined for each year of the project. Whenever feasible, milestones should provide quantitative benchmarks for comprehensively assessing the annual progress of the project. Milestones must not be simply a restatement of the specific aims. Rather, the milestones should offer a timeline and a pathway for the testing of a discovery concept or development of a technology. These milestones will be used to judge the success of the proposed research on an individual-project basis and evaluate the criteria for the program.

Examples of Milestones:

• Verify that the designed composite nanoparticles are able to reproducibly release an activated component at tumor/cancer cell sites in vivo.
• Ascertain that a new targeted nanoparticle can specifically deliver a therapeutic agent to the tumor by demonstrating that agent concentration in tumor exceeds at least x times its blood concentration.
• Demonstrate the ability of a nanoparticle diagnostic construct to detect at least x specific proteins in blood (out of y specific proteins proposed) at a femtomolar level.
• Demonstrate the ability of the proposed nanotechnology to achieve 95% rate of capture for circulating tumor cells in blood.

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 modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• The Data Sharing Plan should address the sharing of nanomaterial data through appropriate publically accessible databases, as described in "Section VI.2. Cooperative Agreement Terms and Conditions of Award."

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

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

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

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Applicants are required to follow our Post Submission Application Materials policy.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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

For this FOA, note the following:

The emphasis and priority of this FOA are on the development of basic or pre-clinical research projects, addressing major barriers in cancer biology and/or oncology using nanotechnology-based solutions. The priority is for innovative projects with high potential to generate significant new knowledge relevant to fundamental understanding of the processes pertinent to the use of nanotechnology in cancer, including interactions of nanomaterials with biological systems and aspects relevant to their delivery to the desirable and intended cancer targets in vivo.

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

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

Significance

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

Specific to this FOA: How relevant is the project to cancer biology and/or oncology? What is the potential of the proposed project to generate fundamental understanding of the processes pertinent to the use of nanotechnology in cancer? What is the potential of the proposed project to advance significantly the fundamental understanding of nanomaterial interactions with biological systems in the context of cancer and/or the mechanisms of their delivery to appropriate cancer targets in vivo? If applicable, how strong is the rationale that the proposed nanotechnology approach may be better than other available approaches for the problem addressed? Will the anticipated advances significantly benefit the broader field of biomedical nanotechnology applications (beyond cancer)?

Investigator(s)

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

Innovation

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

Specific to this FOA: If applicable, how innovative is the nanotechnology approach as compared to other available approaches for addressing the cancer biology and/or oncology problem described in the application? What is the innovative potential of the proposed project in terms of overcoming major barriers that currently restrict the effective use of novel nanotechnology solutions for cancer-relevant problems? For projects focused on new nanomaterials (proposing new nanotechnology constructs), how innovative are the designs of these new nanomaterials (constructs)? For projects focused on the design of tools/devices, what is the innovative potential of the tool(s)/devices(s) designed for the proposed research direction in comparison to known tool(s)/device(s) currently used to address this research area?

Approach

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

Specific to this FOA: Are the proposed hypothesis and/or approaches sufficiently supported by convincing preliminary data? In the case of incomplete data from applicants' laboratories, are these gaps adequately and convincingly addressed using all available sources of information? Will the study methodologies proposed in the project enable the development of a significant body of new knowledge? Are the multi-disciplinary approaches proposed appropriate, well-matched to the nature of the project, and sufficient for optimal and comprehensive addressing of project hypothesis and/or objectives?

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

Environment

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

Milestones

Are the milestones adequately comprehensive and realistic? Will these milestones allow for sufficiently accurate and informative evaluation of the progress of the project proposed?

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.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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.

Trans-Alliance Interactions

What is the potential of the proposed research team for a meaningful synergy with other Alliance components? Would the project proposed benefit from collaborative interactions with the Alliance? Will the application allow flexibility in collaboration with the Alliance? Will the investigators bring valuable areas of expertise to the Alliance that will maximize flexibility for the program?

Applications from Foreign Organizations

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

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

As part of the scientific peer review, all applications:

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

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

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

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

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

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

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

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.

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

Cooperative Agreement Terms and Conditions of Award

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

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

These Terms and Conditions of Award apply to all individual IRCN U01 awards. All the awardee institution(s), PDs/PIs and other key personnel must agree to collaborate on the goals of the IRCN award and the entire NCI Alliance for Nanotechnology in Cancer.

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

• Determining and coordinating research approaches and procedures, and analyzing and interpreting research data;
• Providing goals for procedures and protocols and cost to NCI Program Staff, as requested;
• Releasing data and protocols according to the approved plans for timely sharing of research resources and data generated through the award, as agreed upon by the Alliance Coordination and Governance Committee (CGC) and NCI Program Staff;
• Coordinating and encouraging inter-Alliance collaborations to cross-test novel frameworks and projects proposed by fellow awardees of the NCI Alliance for Nanotechnology in Cancer;
• Serving on the CGC: if selected (for details see Areas of Joint Responsibility below);
• Interacting with the Alliance advisory committees;
• Participating in the annual PD/PI meeting organized by NCI;
• Participating in the program evaluation process, as called upon by NCI Program Director and CGC
• Accepting and implementing all scientific, practical, and policy decisions approved by the CGC to the extent consistent with applicable grant regulations;
• Participating in selection of common animal models for comparative studies across the Alliance;
• Participating in the development of Working Groups supporting the discussion and exchange of ideas across the Alliance;
• Providing information to the NCI Program Director and NCI Project Scientists concerning progress by submitting semi-annual (interim) progress reports in a standard format, as agreed upon by the CGC and NCI Program Staff;
• Providing information to the NCI Program Director and NCI Project Scientists on other aspects of the IRCN project; and
• Providing adjusted annual project milestones each year to the NCI Program Director.
• 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 DHHS, PHS, and NIH policies.

All institutions/organizations participating in a given IRCN project will be expected to share with each other knowledge, data, research materials, and any other resources necessary and relevant to the IRCN award. Also, IRCN awardees are expected to share at least non-proprietary information (e.g., protocols and experimental methodologies) with other investigators in the Alliance program.

To meet nanomaterial data sharing and deposition needs, nanomaterial characterizations, protocols, and associated publications are expected to be submitted to the caNanoLab data portal directly by awardees. Investigators participating in an awarded IRCN project are strongly urged to work together to ensure that all relevant data are deposited to caNanoLab (no later than upon publication of findings in scientific journals). At least one scientifically qualified person is expected to be designated as the nanomaterial data sharing coordinator for each IRCN project after an award has been made.

Awardee members of the Alliance will be required to accept and implement policies approved by the CGC to the extent consistent with grant regulations.

Each IRCN award and the entire Alliance program will be periodically evaluated by the NIH. Awardees will be expected to participate in such evaluation.

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

Designated NCI Program staff members will have substantial programmatic involvement as Project Scientists. Specifically, the NCI Project Scientists will:

• Serve as NCI voting members on the Alliance Coordination and Governance Committee (CGC) (for details see Areas of Joint Responsibility below);
• Assist in avoiding unwarranted duplications of effort across Alliance awardees;
• Help coordinate collaborative research efforts that involve multiple Alliance awardees;
• Monitor the operations of IRCN awards and make recommendations on overall project directions and allocations of project funds;
• Review the progress of individual IRCN projects and specific activities shared among them;
• Participate in the annual PD/PI meeting organized by NCI;
• Participate as Collaborators to the Alliance investigators in some shared activities, if appropriate;
• Assist the awardees as a resource in stimulating their broader interaction with other NCI and NIH programs to disseminate results and outcomes from the Alliance and effectively leverage existing NIH/NCI resources and infrastructures; and
• Evaluate the adherence of IRCN awardees to the approved data sharing plan.
• The NCI reserves the right to award reduction or suspension of funds for an IRCN award that is unable to meet its milestones.
• Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The substantially involved NCI Project Scientist will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications. If such participation is deemed essential, these individuals will seek NCI waiver according to the NCI procedures for management of conflict of interest.

Additionally, an NCI Program staff member acting as a Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. A Program Official may also have substantial programmatic involvement (as Project Scientist/Coordinator). In that case, the individual involved will not attend peer review meetings of renewal (competing continuation) and/or supplemental applications or will seek NCI waiver as stated above.

Areas of Joint Responsibility include:

The Alliance Coordination and Governance Committee (CGC) will serve as the main governing board for the NCI Alliance for Nanotechnology in Cancer program. The committee will consist of the following voting members:

• One representative of each CCNE (one of the Center PDs/PIs, e.g., the corresponding PD/PI);
• Representatives of other awardees funded under the Alliance (i.e., IRCN and T32 training programs). The limit on the number of CGC members representing these two efforts will be set not to exceed the number of PDs/PIs representing CCNEs. Thus the make-up of the CGC will be: 50% CCNE PDs/PIs and the remaining 50% - PDs/PIs of nanotechnology IRCN awards and T32 training programs. The membership of non-CCNE PDs/PIs can be rotated every 18-24 months to provide the opportunity to PDs/PIs of all non-CCNE awards to serve on the CGC committee.
• Two NCI Project Scientists.

Each voting member representing the Alliance awardees will have one vote. Each voting NCI Project Scientist will have one vote.

Two co-chairs of CGC will be named from the members representing the Alliance awardees to coordinate its operation.

In addition, the designated NCI Program Director (who can also act as a Project Scientist) and a representative of the NCI Nanotechnology Characterization Laboratory (NCL) will participate in the activities of the CGC as non-voting members. Additional non-voting members to serve in an advisory capacity may be added to the CGC as needed by a decision of the existing voting committee members. These additional non-voting members may include, as needed, other NCI and NIH Program Staff members and/or Program Staff members from other federal agencies (e.g., Food and Drug Administration [FDA], National Institutes of Standards and Technology [NIST], and/or Department of Defense [DoD]).

CGC may establish advisory or expert sub-committees, as necessary, to ensure the progress of the Alliance. External experts (i.e., non-Alliance members) may be invited to participate in such sub-committees. NCI representatives may serve on any CGC sub-committee as they deem appropriate.

CGC will meet two times a year (at least once in person at the annual PD/PI meeting). All CGC decisions and recommendations that require voting will be based on a majority vote.

Main responsibilities of the CGC will include the following aspects:

• Overall organizational oversight of effort coordination across the CCNEs, IRCN awards, and T32 training programs;
• Review of progress of the research activities across the Alliance and making appropriate recommendations to strengthen activities in certain areas;
• Development of standard research protocols to be used across the Alliance, identifying technology impediments to clinical translation, and developing strategies for sharing technologies and validation results.
• Selection of common animal models (based on tumor types) for comparative studies across the Alliance (a dedicated Alliance expert sub-committee may be formed for this task);
• Development of an appropriate structure of Working Groups to promote the exchange of experiences, protocols, and ideas across the Alliance;
• Review the potential of shared support infrastructure at specific institutions to serve the needs of the investigators across the Alliance;
• Schedule CGC meetings and telephone conference calls as necessary for conducting business;
• Ensure that the Alliance takes advantage of existing NCI and NIH resources and programs;
• Develop and recommend progress report formats for individual CCNEs, IRCN awards, and T32 training programs involved in the Alliance; and
• Schedule and participate in the development of the agenda for the annual PD/PI meeting at which all Alliance investigators will present their scientific progress and future directions.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the CGC 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

In addition to the annual PHS 2590 or RPPR, a detailed interim progress report will be required once a year. This report will be required approximately six months after the annual PHS 2590 or RPPR, and should be submitted directly to the NCI Program Director (with a copy to the designated Grants Administration official).

The interim and annual reports will be required to be formatted following standardized guidelines developed by NCI Program Staff and approved by CGC. The required content of the reports may be changed according to programmatic needs based on discussions among the Alliance members, CGC, and NCI.

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.

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Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-945-7573
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Dr. Piotr Grodzinski
National Cancer Institute (NCI)
Telephone: 301-496-1550
Email: [email protected]

Referral Officer
National Cancer Institute (NCI)
Telephone: 240-276-6390
Email: [email protected]

Arina Kramer
National Cancer Institute (NCI)
Telephone: 240-276-6327
Email: [email protected]

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.