It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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 the U.S.-China Program for Biomedical Collaborative Research is to stimulate collaborative basic, translational, and clinical research between United States (U.S.)-based researchers and Chinese researchers in the areas of cancer, environmental health, heart disease, blood disorders, diseases of the eye and visual system, mental health, and neurological disorders. Clinical trials that examine safety and efficacy or those focused on the development of an intervention are beyond the scope of the FOA. However, the proposed projects may involve optional clinical trials focused on basic mechanistic studies. Partnering U.S. and Chinese investigators must work jointly to submit identical applications to NIH and National Natural Science Foundation of China (NSFC), respectively. U.S. investigators must respond to the announcement from NIH, including the Chinese application as an attachment, and Chinese investigators must respond to a separate funding announcement from NSFC, including the NIH application as an attachment.

The National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) supports international collaborative biomedical research to advance science and expand biomedical knowledge. Scientific cooperation between the U.S. and the People’s Republic of China was initiated over 30 years ago and has grown rapidly in recent years. Recognizing that enhanced cooperative biomedical research would be of mutual benefit to the U.S. and China, the NIH Director and the President of the National Natural Science Foundation of China (NSFC) signed a Memorandum of Understanding (MOU) in October 2010 and renewed in October 2015.

NIH and NSFC signed an Implementing Arrangement (IA) in December 2010 to develop a new U.S.-China Program for Biomedical Research Cooperation. A Joint Working Group (JWG), made up of members from both NIH and NSFC, developed strategic plans for collaboration, review and clearance of proposed U.S.-China projects. Both the NIH and NSFC allocated funds to support joint activities pursued under this program.

Applicants are encouraged to pursue research that takes advantage of unique scientific resources and explores novel scientific questions that can be well addressed only through a partnership between American and Chinese research teams.

Bilateral application and funding process. This FOA is a part of dual and parallel application process for each side of the Partnership with the following rules for the U.S. and Chinese investigators:

U.S. investigators

• U.S. investigators must apply to this announcement from NIH (i.e., RFA-CA-19-009) and must include the Chinese application to NSFC from their partners (as an attachment).
• By sending an application to NIH in response to this FOA (RFA-CA-19-009), the U.S. applicant agrees to provide a complete copy of their submitted NIH application to their Chinese counterpart.
• Potential U.S. applicants concerned about confidentiality or proprietary information should take this requirement into account before deciding what information to submit in their application to NIH. NIH will not consider for funding any application that has not met this requirement.

Chinese investigators

• Chinese investigators must respond to a separate corresponding funding announcement from NSFC (in Chinese, see http://www.nsfc.gov.cn/ ) and must include the NIH application from their U.S. partners (as an attachment).
• By submitting application to the corresponding NSFC announcement, the Chinese applicant agrees to provide a complete copy of their submitted NSFC application to their American counterpart.
• To participate in the joint U.S.-China Program in Biomedical Research Cooperation, Chinese investigators must be current or former NSFC grantees. Only such grantees will be eligible to apply for the corresponding NSFC funding.

Original Rigorous Concepts versus Preliminary Data. In general, the R01 funding mechanism is used for research projects for which research approaches, methodologies, and background information are well established and usually documented by extensive preliminary data from researchers' laboratories. The expectation for well-developed projects extends to this FOA.

However, it is realized that for many of the potential projects there could be gaps in background information and original preliminary data may be scarce or difficult to obtain beforehand. Since the intention of this FOA is, by definition, to promote new research collaborations targeting unique opportunities when working collaboratively with Chinese institutions, the emphasis is on the novelty and significance of the concepts to be explored with a relaxed requirement for preliminary data. These concepts must be original but also rigorous in terms of integrating to the extent possible the available incomplete information for a given area from various sources. Reviewers will assess both aspects jointly; if the conceptual aspects of the proposed project are viewed as exceptionally strong, applicants will not be penalized for some gaps in the preliminary data. The focus of the FOA is definitely on the exceptional opportunities made possible by the US-China collaboration (but combined with rigorous plans to validate those ideas).

Research with Human Subjects. Research involving human subjects, albeit not required, is permitted under this FOA, including research that meets the NIH definition of clinical trials stated in NOT-OD-15-015. However, if such studies are proposed, they must be mechanistic (e.g., designed to understand a biological or behavioral phenomenon, the pathophysiology of a disease, or the mechanism of action of an intervention) and NOT focused on the development of an intervention.

Non-Responsive Studies with Human Subjects. Clinical trials that include clinical development or testing of therapeutic interventions, evaluation of intervention safety, efficacy, clinical management, etc. will be viewed as non-responsive and will not be reviewed.

Adherence to U.S. Regulations for the Conduct of Research Involving Human Subjects and Vertebrate Animals. Applicants and collaborating partners are expected to adhere to U.S. Federal regulations for the conduct of research involving human subjects and vertebrate animals.

This FOA will support studies in the following areas of cancer, environmental health, heart disease, blood disorders, diseases of the eye and visual system, mental health, and selected neurological disorders.

Applications should specifically address the following research priorities of one of the participating NIH Institutes.

Field of Research: Cancer (to be supported by the National Cancer Institute, NCI)

Projects proposed may be focused on any of the listed areas or their combination as appropriate:

• Basic research in cancer biology;
• Research in cancer surveillance, epidemiology, health services, behavioral science, and cancer survivorship;
• Research to assess a person's risk of developing cancer and to find ways to reduce that risk;
• Initial small-scale testing of new anticancer agents and biomarkers;
• Research to identify new and innovative scientific opportunities to improve cancer outcomes in communities experiencing an excess burden of cancer;
• Exploratory programs to develop advanced technologies, trans-disciplinary approaches, infrastructures, bioinformatics and standards to accelerate the creation of publicly available data, knowledge, and tools for cancer research.
• Genomics/Proteomics (e.g., collaborative research leveraging Chinese investments in genomics as well as proteomic data publicly released by NCI’s Clinical Proteomics Tumor Analysis Consortium [CPTAC]) that has been analyzed as part of The Cancer Genome Atlas (TCGA));

NCI Funding Priorities. Within the areas of cancer, the specific funding priorities for this FOA include the following aspects:

Environmental risk factors, such as contaminants in food and water as well as both outdoor and indoor air pollution attributable to cancers in China and the US. Research in the environment may include the following topics, but are not limited to:

• The role of air pollution in cancer (e.g. lung cancers in non-smokers).
• The role of chemical exposures, including those derived from e-waste or low dose chemical exposures, in cancer.

Cancer Types with Regional Prevalence - Topics of interest relating to these cancer types include, but are not limited to

• Nasopharyngeal Carcinoma (NPC) Research on NPCs include, but are not limited to:
• Refining existing screening and treatment strategies, and the development of novel therapeutics for patients with treatment-refractory recurrent disease;
• Examination of the signaling pathway (wnt, Notch, NFkappaB, PI3kinase) aberrations observed in NPC
• Studies on the mechanism(s) that latent Epstein-Barr Virus (EBV) infection exerts on transformation during NPC development
• Role of hypoxia in NPC development
• Genome-wide diversity and the contribution of EBV-associated NPC
• Liver Cancer Liver disease-related cancer research questions include but are not limited to:
• Does the cell of origin influence liver tumor type?
• Do liver cancer stem cells arise and are they found in all liver tumors?
• What is the role of the hepatic stellate cell in cancer progression?
• How do individual cell types/stromal components in the microenvironment influence tumor development or progression?
• Identifying cohorts of cirrhotic patients to study risk(s) for liver cancer. associated with viral (HBV, HCV) and or non-viral (NASH, ALD) etiologies
• Identifying the independent and synergistic role of non-viral risk factors in liver cancer etiology.
• Identifying and/or validating factors for liver cancer associated with specific underlying liver pathology (e.g. NASH, ALD, viral hepatitis).
• Upper GI Cancers Upper GI cancer research questions include but are not limited to:
• Research on early detection and treatment of preneoplastic lesions to reduce mortality.
• Biomarker research to distinguish invasive tumors from benign lesions.
• Research on modifiable risk factors.
• Research seeking to identify biomarkers for early detection and prevention.
• Development of non-invasive methods to primary screen to identify high risk individuals who need screening.

Chinese Medicine and Natural Product Therapeutics Integrative medicine and natural products research areas include, but are not limited to:

• Investigations establishing the efficacy and the effectiveness of traditional Chinese medicines and natural products;
• Mechanisms and translational research on novel therapeutics development including combination approach with conventional cancer care, immunotherapy, and investigational drug/treatment to improve treatment outcome in the areas such as: undruggable targets and novel systems network pathway(s), immune cell function and tumor immune microenvironment, epigenetic pathways, and metabolisms;
• Computational modeling and experimental approaches to improve the accuracy of predicting whether there is any effect, any enhanced therapeutic effects, and adverse effects due to interactions with conventional medicine;
• Investigations of circadian rhythm as a biological variable in Chinese medicine and natural product therapeutics research, such as chronotherapy, and improve sleep on cancer treatment outcome and quality of life.

Genomics/Epigenomics/Transcriptomics (including Epitranscriptomics)/Proteomics Because of the large investments made in cancer genomics by both the U.S. and China, there is an opportunity for novel data analytics projects utilizing those resources. Research in this area includes, but is not limited to, mining/leveraging of TCGA and CPTAC data and Chinese genomics data to identify and understand genomic landscape of various cancer types understanding the role(s) of genes, non-coding RNAs, and gene products in tumorigenesis, progression, and metastasis.

Field of Research: Eye and Visual System (to be supported by the National Eye Institute, NEI)

The NEI is interested in the development of new animal models that more closely mimic the biology of human visual system and the pathophysiology of human ocular disease than do existing models. Specifically, the NEI priority is on cone-dominate models that overcome the differences between the structural and functional characteristics of the rodent retina versus those in humans. Such models should allow for advancing our knowledge of disease mechanisms, identifying biomarkers of disease processes, and developing new treatments for blinding diseases in humans. Appropriate models might include, but are not limited to, non-human primate models or 3-D organoids derived from human cell lines. The NEI is also interested in regenerative medicine approaches for restoring visual function lost because of genetic abnormalities or disease processes.

Scientific areas of special interest to NEI:

• Development and characterization of new, translation-enabling models of ocular diseases
• Transgenic and genome-editing technologies such as CRISPR/Cas9 in animal models closer to human anatomy and pathophysiology than current models
• Improved viral and non-viral gene therapy vectors for use in non-human primate models of ocular disease
• Regenerative medicine approaches using stem cell-replacement strategies for replacing lost or dysfunctional photoreceptors and retinal ganglion cells
• Methodology for converting intrinsic cells such as Muller glia into neuronal replacements for photoreceptors and RGCs

Field of Research: Environmental Health Sciences (to be supported by the National Institute of Environmental and Health Sciences, NIEHS)

The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people to promote healthier lives. The NIEHS is interested in supporting collaborative research and research training through joint U.S.-China partnerships that address or seek to understand how exposures to toxic environmental insults alter biologic processes and are linked to disease initiation, progression, or morbidity. In addition, NIEHS is interested in research that leads to the development of prevention and intervention strategies to reduce environmentally induced diseases. Examples of environmental exposures relevant to the mission of the NIEHS include, but are not limited to, industrial chemicals or manufacturing byproducts, e-waste, metals, pesticides, herbicides, and inhaled toxicants including indoor air pollutants from cooking and other sources, climate variability and the environmental impacts of natural and man-made disasters. NIEHS is interested in exposures throughout life and disease outcomes than manifest throughout the lifespan. Early life exposures and their biological consequences are of particular interest and include exposures before and during pregnancy and children’s environmental health outcomes that may arise from these exposures. Understanding the risk of diseases that arise throughout adulthood are also of interest, such as respiratory and cardiovascular disease, reproductive and endocrine system disorders, neuro-degenerative diseases, many types of cancer, and kidney disease are of interest. Exploring the impact of environmental exposures on biological pathways and genetic determinants related susceptibility are also encouraged.

NIEHS supports research examining health consequences due to the interplay between environmental exposures and cofactors such as infectious agents or social factors that contribute to environmental health disparities.

Field of Research: Mental Health (to be supported by the National Institute of Mental Health, NIMH)

Research focused on systems and cellular neuroscience as they relate to mental disorders, including:

• Use of non-human primates to study neurobiological processes underlying cognitive, social, and affective behavior;
• Development of non-human primate models of single-gene disorders to recapitulate the same genomic modification that leads to the mental disorder in human patients, and to use these models to test gene manipulation methods to subsequently correct the genetic defect in vivo;
• Development of novel tools and methodologies, including imaging tools and assays, single cell analyses and omics, that allow high throughput phenotyping in cell model systems;
• Improvements in stem cell-based methods (e.g., cell type optimization, physiologically relevant 2- and 3-dimensional cellular organization and function) tailored to studying the molecular and cellular basis of mental disorders;
• Comprehensive use of imaging genetics in patients or healthy control subjects and neurobiological characteristics in brain bank tissues to explore the mechanism of common mental disorders.
• Development of new computational theories, models, and statistical tools to derive functional principles of brain-behavioral function in basic neuroscience and dimensional psychopathology.

Research focused on the development of an integrative scientific literature that can inform future, neuroscience-based diagnostic systems, consistent with NIMH’s Research Domain Criteria initiative. Such studies should include the following elements:

• Primary hypotheses based on one or more of the defined RDoC domains and constructs;
• Multiple units of analysis (i.e., genes, molecules, circuits, physiology, behavior, and self-report);
• Recruitment methods and eligibility criteria that are likely to yield a broad range of severity of the symptoms or problems to be explained, spanning healthy to symptomatic individuals, and avoiding recruitment based strictly on diagnostic criteria;
• A dimensional approach to data analysis which does not focus only on the extremes of the constructs under investigation. Novel, data-based (rather than diagnosis-based) groupings of individuals are acceptable.

Research focused on the neurodevelopmental basis of serious mental illness, including:

• Studies of the prodrome of major mental disorders (e.g. schizophrenia and bipolar disorder);
• Identification of biomarkers and behavioral markers with predictive values for diagnosis and treatment;
• Characterization of developmental processes across biological and behavioral systems that give rise to mental illnesses over the lifespan;
• Determination of sensitive periods and specific factors that modify typical and atypical mental health trajectories;
• Identification of early biological and environmental risk and protective factors for serious mental illness.

Pilot or exploratory services research, including studies to:

• Identify mutable factors that affect access to preventive or mental health treatment services or that affect the quality, implementation, efficiency, use, and outcomes of such services, and that may become targets for intervention development;
• Develop, refine, or apply innovative computational or data science analytic approaches for analyzing complex and dynamic service systems and their impact on service user outcomes;
• Design or validate measures of: change in service user functioning, provider practice, or other service intervention targets or outcomes; dissemination, implementation, or sustainability of evidence-based practices; or organizational or systems-level variables hypothesized to affect implementation or outcomes of mental health care.

Note: for applications focused on the area of Mental Health, clinical research is responsive under this FOA, but clinical trials are non-responsive. Applicants who wish to conduct a clinical trial focused on mental illness should review information about NIMH’s direction for clinical trials research and the relevant FOAs at http://www.nimh.nih.gov/funding/opportunities-announcements/clinical-trials-foas/index.shtml. Collectively, these FOAs define NIMH’s focus on an experimental therapeutics approach when supporting clinical trial research.

Field of Research: Neurological Disorders (to be supported by the National Institute of Neurological Disorders and Stroke, NINDS)

NINDS is interested in applications addressing basic or clinical research across the spectrum of neurological, neuromuscular, neuroinfectious and neurovascular diseases and disorders within the Institute’s mission and of significance to China (refer to NINDS Disorder Index at http://www.ninds.nih.gov/disorders/disorder_index.htm). NINDS is also interested in BRAIN Initiative research focused on mapping and understanding brain circuits.

• Applications proposing clinical trials that examine safety and efficacy or those focused on the development of an intervention;
• Applications focused on Mental Health that propose any clinical trials; and
• Research involving Select Agents (see 42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens).

See Section VIII. Other Information for award authorities and regulations.

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

Higher Education Institutions

• 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
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government -- including the NIH Intramural Program, with eligibility restricted to intramural investigators from the National Cancer Institute, National Institute for Environmental Health Sciences, National Eye Institute, and the National Institute for Neurological Disorders and Stroke
• U.S. Territory or Possession

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 not 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) 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 to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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: The Chinese collaborators must not be designated as PDs/PIs on the application in response to this FOA.

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).

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) 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.

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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Paul Pearlman
Program Director
National Cancer Institute
Telephone: 240-276-5354
Fax: 240-276-5820
Email: [email protected]

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.

Facilities and Other Resources:

Applicants must include a description of available resources, naming which collaborative partner is contributing which resources, and a description of how resources will be appropriately shared (e.g., individual contributions of specific reagents, patient samples, compounds, and access to populations for epidemiologic studies). If biospecimens will be exchanged or shipped from the NFSC collaborator to the U.S. PD(s)/PI(s), and vice-versa, applicants should specify the type of biospecimens to be shared and describe the plan to obtain approval for exchange or shipping from the Chinese or U.S. government, addressing plans to perform the project aim associated with the biospecimens if approval to transfer or ship the specimens is not granted.

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

Chinese investigators should be included as Senior/Key Persons in the application.

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

Budget request may include funds to prepare, document, and archive data to facilitate data sharing.

The Chinese investigators and work covered by the parallel award from the NSFC should not be included in the budget.

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: Provide the overall goals for the entire application. When defining Specific Aims indicate which side of the partnership (U.S. or Chinese investigators) will be mainly responsible for specific aspects.

Research Strategy: The content of Research Strategy section in the NIH application submitted in response to this FOA must match the respective content of the linked NSFC application. This content must reflect the activities to be performed by both sides of the partnership, i.e., by both the U.S. and Chinese investigators.

Use the standard Research Strategy subsections (Significance, Innovation, and Approach) to describe the proposed project. In addition to typical content elements, this description should also address all the specific aspects listed below.

Significance

Describing the significance of the project, explain how the approach will stimulate collaborative basic, translational, or clinical research between the U.S. PD(s)/PI(s) and NFSC collaborative partner.

Innovation

Highlight innovative aspects that expressly result (or are made possible) by the partnership between the U.S. and Chinese investigators (e.g., availability/access to unique populations, resources, etc.)

Approach

Describe the organizational structures, roles and responsibilities of the U.S. PD(s)/PI(s) and NFSC collaborative partners in accomplishing the proposed research.

Provide a description of the collaborative research, detailing the integration of the U.S. and Chinese collaborator efforts.

Specifically include communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts. Contingency plans addressing solutions to setbacks and delays should also be included.

Letters of Support: Applicants should include Letters of Support co-written and co-signed by the PD(s)/PI(s) and the Chinese collaborating partners and co-signed by the authorizing institutional officials confirming the new or existing collaboration and confirming that the U.S. awardee organization will provide a copy of the NIH submitted application to the NSFC through their Chinese collaborating partner.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan.
• In line with the goals of the FOA, Resource Sharing Plan should ensure that the outcomes of the collaborative research and unique resources to be created are optimally shared.
• Whenever possible, the plans should facilitate sharing the final research data generated by the partnering investigators between both the NIH-funded and NSFC-funded investigators and the joint publication of study results. Specific plans and timelines may be subject to applicable rules of the institutions involved regarding such aspects as anonymization/de-identification measures, intellectual property, publication/disclosure embargo clauses, etc.
• Consult the NIH Data Sharing Policy for additional guidance: https://grants.nih.gov/grants/policy/data_sharing/ .

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. The following modification applies:

All applicants must include in the Appendix the full application, in English, submitted to the NSFC by the Chinese collaborating team.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Applicants proposing optional clinical trial must complete study record.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

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Applications Involving the NIH Intramural Research Program

The requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as PDs/PIs in accord with the Terms and Conditions provided in this FOA. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include the collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process.

Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The review criteria used for applications submitted to this FOA by U.S. investigators are harmonized with review criteria that will be used for review of applications from Chinese investigators responding to the parallel NSFC announcement.

In addition, for applications involving clinical trials:

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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

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

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

Specific to this FOA: To what extent does the proposed project take advantage of the opportunities, distinct resources, capabilities, and/or other distinct/unique factors made possible through the partnership between the U.S. and Chinese investigators?

In addition, for applications involving clinical trials:

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

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

In addition, for applications involving clinical trials:

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

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

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

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

Specific to this FOA: How optimal is the distribution of responsibilities between the proposed U.S. and Chinese teams? How strong are the plans for the conduct of collaborative activities in terms of the integration of the U.S. and Chinese collaborator efforts, communication plans, process for making decision on scientific directions, procedures for resolving conflicts, and other related aspects? How well is the Resource Sharing Plan aligned with the goals of the FOA to ensure that the outcomes of the collaborative research and unique resources to be created are optimally shared?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Specific to applications involving clinical trials:

Study Timeline

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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.

Not Applicable.

Not Applicable.

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.

Not Applicable.

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).

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

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 Center for Scientific Review, 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or 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.
• Funding decisions for applications submitted to NIH will be made by NIH with consideration of the research priorities of the U.S.-China program, including the applicants demonstrating the collaborative nature of the proposed work supported by applicable biospecimen and data sharing plans. Both the U.S. and Chinese applications must be determined to be eligible and responsive (in the parallel processes conducted by the NIH and NSFC) to be considered for funding under the program.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety

Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Paul Pearlman
National Cancer Institute (NCI)
Center for Global Health
Telephone: 240-276-5354
Email: [email protected]

Tram Lam
National Cancer Institute (NCI)
Division of Cancer Control and Population Sciences
Telephone: 240-276-6967
Email: [email protected]

Dan Xi
National Cancer Institute (NCI)
Division of Cancer Treatment and Diagnosis
Office of Cancer Complementary and Alternative Medicine
Telephone: 240-276-6143
Email: [email protected]

Betsy Read-Connole
National Cancer Institute (NCI)
Division of Cancer Biology
Telephone: 240-276-6190
Email: [email protected]

Jo Ann Rinaudo
National Cancer Institute (NCI)
Division of Cancer Prevention
Telephone: 240-276-7133
Email: [email protected]

Wendy Wang
National Cancer Institute (NCI)
Division of Cancer Prevention
Telephone: 240-276-7117
Email: [email protected]

Ping Hu
National Cancer Institute (NCI)
Division of Cancer Prevention
Telephone: 240-276-7015
Email: [email protected]

Lisa Neuhold
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]

Andrea Horvath Marques, M.D., Ph.D., M.P.H
National Institute of Mental Health (NIMH)
Telephone: 301-443-3945
Email: [email protected]

Claudia Scala Moy
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9135
Email: [email protected]

Abee Boyles
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 984-287-3241
Email: [email protected]

Amy Lynn Rubinstein, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-408-9754
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: [email protected]

Karen Smith
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]

Bryann Benton
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-323-3241
Email: [email protected]

Rebecca Claycamp, M.S.
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email: [email protected]

Tijuanna Decoster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
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 Part 75.