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 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 allergy, immunology, and infectious diseases including HIV/AIDS and its co-morbidities and co-infections, cancer, mental health, and selected neurological disorders.

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.

U.S. and Chinese collaborating investigators will work together to submit corresponding applications to NIH and NSFC, respectively. U.S. investigators will respond to the announcement from NIH, and Chinese investigators will respond to a separate funding announcement from NSFC. By sending an application to NIH, the 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 sharing requirement.

Eligibility for NSFC funding under these collaborative projects is limited to scientists who are current or former NSFC grantees. NSFC will publish a corresponding funding announcement (in Chinese) for partnering Chinese investigators to apply for funding under the joint U.S.-China Program in Biomedical Research Cooperation (see http://www.nsfc.gov.cn/Portal0/InfoModule_396/More.htm). Applications from Chinese investigators responding to the NSFC announcement will be reviewed in parallel by NSFC using review criteria that are harmonized with NIH review criteria. Applicants responding to the NSFC announcement will also be required to submit as part of their applications a copy of the NIH application provided by their U.S. collaborator. Therefore, it is expected that the Chinese collaborator will contact the U.S. Program Directors/Principal Investigators (PD(s)/PI(s)) and request a copy of their application in response to this announcement for submission. This application will also be reviewed confidentially during the NSFC review process.

Funding decisions for applications submitted to NIH will be made by NIH with consideration of the research priorities of the U.S.-China program. 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.

This FOA will support studies in the following areas of allergy, immunology, and infectious diseases including HIV/AIDS and its co-morbidities and co-infections, mental health, and selected neurological disorders.

NIAID - Immunology (non-HIV/AIDS):

Host immune response and/or regulation and/or immunopathogenesis of the inflammatory effector response to microbial and/or viral infection. Additionally, studies that elucidate the underlying mechanisms that result in immune memory and protection in response to vaccination. Topics of interest relevant to immunity to infection and/or vaccination include, but are not limited to:

• Differentiation and activation of innate and adaptive immune cells and signaling pathways;
• Positive and negative regulation of inflammation;
• Mechanisms by which the innate immune system directs subsequent adaptive immune responses;
• Generation and maintenance of effector and memory antigen-specific T and B lymphocytes;
• Generation and maintenance of anti-viral effector innate lymphocytes;
• Regulation of differentiation and maintenance of effector and memory antigen-specific T and B lymphocytes;
• Migration of na ve, memory and effector cells during the induction and effector phases of immune responses and their therapeutic modulation;
• Generation, differentiation and maintenance of tissue-resident antigen-specific lymphocytes;
• Responses of tissue-resident lymphocytes to microbial and/or viral infections;
• Regulation of antibody production and mechanisms of antibody-mediated protection
• Definition of biomarkers of protective immune responses;
• Characterization of innate and adaptive mucosal immune responses;
• Relationship between mucosal immunity and the development of, or protection from, autoimmune disease;
• Mechanisms of immune-mediated pathogenesis triggered by responses to microbial and/or viral infection;
• Effect of viral and microbial infections, and environmental pollutants on systemic/regional innate immunity and epithelial/mucosa functions and their contribution to the pathogenesis of asthma, allergic diseases, or autoimmune diseases, and the relationship to commensal microbiota.

NIAID - Infectious Diseases (non-HIV/AIDS):

Research on infectious diseases (non-HIV/AIDS) should focus on malaria, tuberculosis, dengue fever, enterovirus 71, rabies, schistosomiasis, measles, hepatitis, or influenza and include one of the following areas:

• Antimicrobial resistance, including mechanisms of resistance;
• Resistance in disease vectors;
• Immune responses to infectious diseases or vaccines, including the role of immune responses in pathogenesis;
• Molecular characteristics of innate immunity in acute or chronic infections and strategies for modulation of the immune responses.

NCI - Cancer:
Applications should be focused in the following areas:

• Genomics/Proteomics (e.g., collaborative research leveraging 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));
• Nanotechnology (e.g., collaborative research focused on translating genomic targets into cancer therapeutics using nanotechnology and studies on structure-activity relationships in nanomaterials and their safety);
• Immunotherapy/ new immune inhibitory receptors/co-inhibitory molecules in tumor progress;
• Liver cancer studies as a result of carcinogen exposure, high fat diets, or high alcohol intake;
• DNA damage networks as a target for cancer cells; synthetic biology studies of engineered cells to study biological networks; and the effects of lipid addiction on tumor cells.

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

Genomics/Epigenomics/Transcriptomics (including Epitranscriptomics)/Proteomics

• Mining/leveraging of TCGA data or proposed work 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.
• CPTAC coordinated effort to understand molecular basis of cancer by systematically identifying proteins that derive from alterations in cancer genomes.

Nanotechnology

• Collaborative applications that propose the use of nanotechnology to delineate cancer-associated pathways as a means to characterize and functionally validate cancer genomic findings in relevant cell and animal models
• Applications that propose the use of nanotechnology to enable cancer biomarker discovery and validation.
• Research directed towards uncovering structure-activity relationship in nanomaterials and correlation between nanomaterial properties and their safety profiles would also be supported by this FOA.
• Nanotechnology for immunotherapy application thay propose to characterize the physiological parameters of nanostructures targeting mononuclear phagocyte system, such as monocytes, macrophages and dendritic cells. Delivering agonists by targeting innate immune sensing pathways with nanotechnology to improve antigen presentation.
• Targeting immune regulatory cells (e.g. tumor-associated macrophages) to ameliorate tumor immunosuppressive microenvironment.
• Developing immunotherapy with nanotechnology to improve conventional therapies.

Cell engineering

• Approaches using synthetic biology to improve the understanding of biological networks and/or to develop live intelligent agents to test new diagnostic and therapeutic strategies.

DNA-damage network as a target in cancer cells

• Development of molecule tools and imaging and single-cell and single molecule technology to detect induction , expression and de-construction of molecular complexes that are formed in response to genotoxic therapy a variety of human cancers;
• Characterization and targeting of DNA repair in cancer stem cells and/or quiescent cancer cells in Go or G1;
• Establishing the role of DNA damage response communication with the microenvironment induced by cancer therapy (e.g., ionizing radiation) and effects such communication has on resistance to treatment and cancer progression in the face of high levels of DNA damage/replication stress;
• Exhaustive studies to determine synthetic lethal relationships related to cancer-cell defects in DNA repair or DNA replication for range of human cancers and grades.

Liver Cancer Research questions include:

• 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 progression.

Lipid addiction of cancer cells

• The effects of dietary fat intake/obesity on the activation of fatty acid synthesis in cancer cells;
• The effects of lipid droplets on the induction of fibrosis.

Novel strategies of cancer immunotherapy

• Amplification/modification of immune effectors (e.g., with Chinese herbs);
• Recruitment of immune effectors to the tumor site;
• Targeting tumor stromal cells;
• Prevention of side effects.
• Antigen-based design of cellular effectors (e.g. CTL, NK);
• Cancer vaccine including DC vaccine;
• Immune molecule monitoring;
• New immune inhibitory receptors/co-inhibitory molecules in tumor progress.

NIMH - Mental Health:

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;
• Use of non-human primates to create genetic model animals of single-gene disorders beyond Rett syndrome, and to use these models to test gene manipulation methods to subsequently correct the genetic defect in vivo;
• Research to increase the sophistication of data analyses, (e.g., neuroimaging studies);
• 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 techniques to study the molecular and cellular basis of mental disorders;
• Comprehensively using the imaging genetics in patients or healthy control subjects and the neurobiological characteristics in brain bank tissues, to explore the mechanism of common mental disorders (schizophrenia, autism, etc.).

Biologically-relevant computational modeling of neural circuit activity that relates to behavior and/or psychological and cognitive processes in mental health and mental disorders.

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;
• Studies of autism, particularly those focused on genomics or early biomarkers, early detection, and/or treatment development.

Note: Clinical research is permissible under this FOA, but clinical trials are not. Applicants who wish to conduct a clinical trial focused on mental illness should review information about NIMH’s new 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.

NINDS:

The NINDS will support novel collaborative research projects in the areas of Parkinson's disease (PD) and related disorders, stroke, epilepsy, and vascular contributions to cognitive impairment. Applicants are advised to refer to NINDS policy regarding rigorous study design and transparent reporting and to incorporate these standards into their proposed research,

http://www.ninds.nih.gov/funding/transparency_in_reporting_guidance.pdf.

Research topics include, but are not limited to:

• Studies in animal models or human subjects to identify genetic and environmental risk factors as well as epigenetic mechanisms in disease or in specific disease subtypes (e.g., PD, intracerebral hemorrhage, intracranial stenosis, small vessel disease or vascular cognitive impairment);
• Collaborative research that develops, characterizes, validates and utilizes transgenic animal models and large animal models, such as non-human primates in the following areas:
  • Biomarkers of disease mechanisms and progression;
  • Therapeutic targets;
  • Pathophysiological basis of diseases.
• Collaborative neuroimaging studies for early diagnosis and progression of disease as well as recovery after stroke;
• Prospective studies on non-motor and cognitive changes in PD and related disorders or cognitive impairment and dementia due to cerebrovascular disease ;
• Collaborations in database comparison and data sharing as appropriate (e.g., hospital-based and community-based studies of target neurological disorders).

Note: US applicants who plan to conduct studies on PD and related disorders on US patients should be aware that:

• All genetic studies are expected to share data via dbGaP (http://www.ncbi.nlm.nih.gov/gap).
• All laboratory-based PD studies on human specimen and clinical PD biomarker projects, including imaging studies, must be compliant with the PD Biomarkers Program (PDBP) requirements (http://grants.nih.gov/grants/guide/notice-files/NOT-NS-11-020.html).
• Specifically, some human biological samples collected under this program may be required to be deposited in the NINDS repository as stated in https://grants.nih.gov/grants/guide/notice-files/NOT-NS-15-046.html.
• In addition, all such projects must utilize the PDBP Data Management Resource (DMR) when sharing clinical, imaging and biological data. A detailed plan for data sharing via the DMR is expected to be included in the data sharing plan.
• When planning, applicants should take into consideration the above policies, and also engage the approval process in China for international sharing of the biological samples and genetic data as appropriate.

HIV/AIDS and Co-Morbities:

Priority HIV/AIDS topic areas include:

• Treatment: Improved treatment outcomes, including:
  • Developing and testing novel therapeutic approaches combining virologic-, immunologic-, and cellular-based therapies.
  • Implementation research to ensure early initiation of treatment, adherence to treatment regimens, retention and engagement in these services, and achievement and maintenance of optimal prevention and treatment responses.
• Prevention: Reducing incidence of HIV/AIDS, including:
  • HIV phylogenetics: Novel applications to identify hotspots of transmission, phylogenic and epidemiologic analyses of HIV dynamics and models of transmission.
  • Vaccine research: AIDS vaccine candidates, including but not limited to identification of candidate novel immunogens, novel adjuvants, or initial characterization of high-risk populations for possible participation in future clinical trials of AIDS vaccines or combination prevention strategies.
• Co-Morbidities: Improved prevention or treatment of HIV-associated comorbidities, co-infections, and complications, including:
  • Tuberculosis (basic as well as clinical research): Pathogenesis of TB/HIV co-infection, evaluating biomarkers to predict TB disease outcomes (including risk of activating latent infection), and pre-clinical development of novel immune-based therapeutic and prevention modalities for TB/HIV co-infection and disease.
  • Non-infectious comorbidities: Complications associated with long-term HIV disease and antiretroviral therapy, such as cardiovascular and metabolic disorders, neurologic and neurocognitive disorders, and conditions associated with premature aging.
  • AIDS-related malignancies: Studies that optimize the diagnosis, prevention and treatment of HIV-associated cancers, including development of biomarkers for early detection, progression, or response to treatment of HIV-associated cancers. Particular interest in virally associated malignancies such as Kaposi sarcoma, lymphoma, and cervical cancer.
• Cross-Cutting Topics: Other cross-cutting topics include basic research that underpins the development of strategies for the areas listed above; studies focusing on reducing health disparities in the incidence of new HIV infections or in treatment outcomes of people living with HIV/AIDS; and training.

Research involving human subjects (clinical research) is permitted under this FOA. For the NIH definition of clinical research versus clinical trials, please see: http://funding.niaid.nih.gov/researchfunding/sci/human/pages/default.aspx.

Note: applicants and collaborating partners are expected to adhere to NIH regulations for the conduct of research involving human subjects and vertebrate animals.

Unlike a standard R01 application, preliminary data are not required under this FOA; however, supporting evidence for past productivity, proposed approach, and techniques should be included.

Scope of research or activities NOT supported under this FOA:

• Any clinical trial including clinical trials of drugs, biologics, or diagnostics (see NIH definition of clinical trials in the Application Guide SF424). For NIH definitions of clinical research vs. clinical trials, please see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html.
• 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).

Note: For further information on the U.S.-China Program for Biomedical Collaborative Research please visit the following website for general information and questions and answers http://www.niaid.nih.gov/researchfunding/qa/Pages/revniaid.aspx#indiv.

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
• 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
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

• 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.

The PD(s)/PI(s) must be from a U.S. institution, and the applications must name the NSFC investigator as a collaborating partner.

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).

Applicants must obtain 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.

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:

Applicants should include only budget information for the activities for which they are requesting NIH support. Do not include budget support for the activities that will be requested by the corresponding NSFC application and funded by the NSFC.

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:

Research Strategy: Applicants should clearly describe the specific aims of the project and how the approach will stimulate collaborative basic, translational, or clinical research between the U.S. PD(s)/PI(s) and NFSC collaborative partner. In addition, describe the organizational structures, roles and responsibilities of the U.S. PD(s)/PI(s) and NFSC collaborative partners in accomplishing the proposed research. As applicable, highlight unique populations, resources, or hypotheses that benefit from the proposed collaboration. The description of the collaborative research, detailing the integration of the U.S. and Chinese collaborator efforts, should 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. In addition, applicants should 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), applicants should specify the type of biospecimens to be shared and describe the plan to obtain approval for exchange or shipping from the Chinese government, addressing plans to perform the project aim associated with the biospecimens if approval to transfer or ship the specimens is not granted.

Note: Although preliminary data are not required under this FOA, evidence supporting past productivity, proposed approach, and techniques should be included.

Letters of Support: Applicants should include a Letter of Support co-written and co-signed by the PD(s)/PI(s) and the Chinese collaborating partner 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, should address a Data Sharing Plan.

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.

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.

The NIH will make awards to the U.S. institution, while the NSFC will make awards to the Chinese collaborator.

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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

Reviewers will provide an overall impact 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 there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Is the proposed project likely to stimulate collaborative basic, translational, or clinical research between U.S.-based researchers and Chinese researchers? Does the project highlight the unique populations, resources, or hypotheses that benefit from the proposed collaboration?

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?

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

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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?

Does the application clearly state which partner of the collaboration will be responsible for accomplishment of each proposed specific aim? Does the application provide appropriate plans for the collaborative research, demonstrating the integration of the U.S. and Chinese collaborator efforts, including communication plans, process for making decision on scientific direction, and procedures for resolving conflicts? Does the application provide appropriate contingency plans and/or solutions for addressing setbacks and delay, including those related to biospecimen transfer or shipping?

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?

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?

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.

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.

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.

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 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.
• Relevance to the collaboration between the U.S. and China.

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.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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.

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 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.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Conrad Mallia, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-7551
Email: CMallia@niaid.nih.gov

Paul Pearlman, PhD
National Cancer Institute (NCI)
Telephone: 240-276-5354
Email: paul.pearlman@nih.gov

Polly Sager, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-1884
Email: PSAGER@niaid.nih.gov

Gerald B. Sharp, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3217
Email: gsharp@niaid.nih.gov

Brigitte E. Sanders, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3209
Email: sandersbe@niaid.nih,gov

Beverly Pringle, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-443-3725
Email: bpringle@mail.nih.gov

Hao Wang, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
Email: hao.wang2@nih.gov

Natalie Tomitch, M.P.H., M.B.A
Office of AIDS Research (OAR)
Telephone: 301-451-0098
Email: tomitchn@od.nih.gov

Mary Nguyen, M.P.H.
Office of AIDS Research (OAR)
Telephone: 301-594-4946
Email: nguyenmary@od.nih.gov

Alexander Politis, PhD
Center for Scientific Review (CSR)
Telephone: 301-435-1150
Email: politisa@csr.nih.gov

Philip Smith
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2948
Email: philip.smith2@nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Rebecca Claycamp, M.S.
National Institute of Mental Health (NIMH)
Telephone: 301-443-2811
Email: Rebecca.claycamp@nih.gov

Tijuanna E. DeCoster, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@mail.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 .