Required Application Instructions

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

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

The purpose of this Funding Opportunity Announcement (FOA) is to stimulate collaborative research opportunities between investigators in the U.S. and China focused on research toward a cure for HIV/AIDS.

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.

NIH and NSFC signed an Implementing Arrangement (IA) in August 2013 to develop a new U.S.-China collaborative program focused on research toward a cure for HIV/AIDS. Both the NIH and NSFC have allocated funds to support joint activities pursued under this program.

U.S. and Chinese collaborating investigators should work together to submit corresponding applications to NIH and NSFC. U.S. investigators will respond to this 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.

The NSFC will publish a corresponding funding announcement (in Chinese) for partnering Chinese investigators to apply for funding under the joint U.S.-China Program for Research Toward a Cure for HIV/AIDS (see http://www.nsfc.gov.cn/publish/portal0/tab87/). 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.

Although highly active antiretroviral therapy (HAART) effectively suppresses HIV viral replication below the limit of detection in most infected individuals, a reservoir of infected cells persists. It is now clear that these regimens alone are insufficient to cure HIV-positive individuals of their infection. While the effects of long-term HAART and the presence of persistent virus necessitate an alternative treatment strategy, many critical questions about the origin of rebound virus and the details of how viral reservoirs are established and maintained remain unanswered. This FOA will support studies in research toward a cure for HIV/AIDS including but not limited to the following areas:

• Investigation of the mechanisms of establishment and maintenance of HIV-1 latency at the cellular, tissue and organismal level
• Identification of viral reservoirs that cause rebounding of viral levels when antiretroviral therapy is stopped
• Design of novel virologic-, immunologic-, and cellular-based therapies for immune containment or eradication of HIV reservoirs
• Development of sensitive and quantitative assays, methods, or imaging techniques, that can be applied to the measurement of residual HIV reservoirs in HIV-positive individuals on effective antiretroviral therapy
• Identification of means to specifically re-activate HIV gene expression in latently infected cells in vivo without affecting uninfected bystander cells
• Studies of HIV reservoirs and persistence in individuals, including infants, children, and adolescents treated very early after infection.
• Studies with a focus on central nervous system HIV reservoirs such as macrophages, microglial cells, and astrocytes with and without substance abuse.
• Studies to help understand the impact on HIV reservoirs of anticancer treatments in patients with both HIV and cancer.
• Studies on how approaches such as bone marrow transplants used in cancer therapy impact latent HIV reservoirs.
• Studies that address the impact of either acute or chronic use of alcohol on the establishment and persistence of latent HIV infection, long-term maintenance of latency infected cells, or the dynamics of reactivation from latency.

For the purposes of this FOA, a latent viral reservoir is defined as an infected cell population that allows for the indefinite persistence of replication-competent HIV-1 in patients on optimal HAART regimens. Studies that plan to utilize a non-human primate model for in vivo proof-of-concept should substitute SIV or SHIV viruses in place of HIV where applicable.

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

Since a principal goal of this program is to attract and support new ideas, a key feature of this FOA is that preliminary data, unlike as in standard R01 applications, are not required.

• Any clinical trials including clinical trials of drugs, biologics, or diagnostics
• Research that is NOT related to HIV or AIDS (SIV and SHIV research is allowed)
• Any study involving Select Agents
• Applications received that are not paired with a corresponding NSFC application from a Chinese collaborating investigator. 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.

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.

This FOA must list at least one Investigator from a U.S. institution as the PD(s)/PI(s) and name the NSFC investigator as a collaborating partner. The NSFC collaborator must be a current or former NSFC grantee. NSFC investigators who received funding from the previous U.S.-China Program for Biomedical Collaborative Research (RFA AI-12-021) are NOT eligible to apply to this funding opportunity. U.S. investigators that received NIH funding from the previous U.S.-China Program for Biomedical Collaborative Research (RFA-AI-12-021) are eligible to apply to this funding opportunity.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

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

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

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

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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:

Robert Freund, Ph.D.
Center for Scientific Review
6701 Rockledge Drive, Room 3216
Bethesda, MD 20892-7852
Telephone: 301-435-1050
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 should include a description of available resources, naming which collaborative partner is contributing which resources, and a description of how resources will be shared (e.g., individual contributions of specific reagents, patient samples, compounds, and access to populations for epidemiologic studies). If biospecimens will be imported from China to the U.S., applicants should specify the type of biospecimens and whether an application has been filed for Chinese government approval to export these materials. Also specify how the work can be completed if this approval is not granted.

Other Attachments: Applicants should include a Collaboration Plan that clearly defines the interactions between and integration of the U.S. and Chinese investigator’s efforts, how information and resources will be exchanged among the groups, plans for communication, processes for making decisions on scientific direction, and procedures for resolving conflicts. Contingency plans addressing solutions to setbacks and delays should also be included.

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

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

Applicants should include only budget information for the activities for which they are requesting NIH funds. The NIH will make awards to the U.S. institution while the NSFC will make awards to the Chinese collaborator. Do not include budget information for activities requested from the corresponding NSFC application through 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:

Specific Aims: Clearly describe the specific aims of the project and the organizational structures, roles and responsibilities of the U.S. PD(s)/PI(s) and NFSC collaborative partners in accomplishing the proposed research.

Research Strategy: Applicants should propose a single Research Strategy for the combined efforts of the two organizations (U.S. and Chinese collaborators). The Research Strategy should provide a complete description of the research, demonstrating the integration of the collaborative efforts.

While studies involving transformed cell line models for latency may be useful for initial studies, subsequent studies must be performed using primary cells. Latently infected reservoir cells from HIV-positive individuals on optimized HAART should be used whenever possible. Additionally, applicants are highly encouraged to study latently infected cells from a variety of tissues rather than only latently infected cells isolated from cells circulating in the periphery.

Note that preliminary data are not required to be included within the Research Strategy; however relevant information or data that supports the development of a sound rationale/hypothesis may be included.

Letters of Support: Applicants must include a Letter of Support co-written and co-signed by the PD(s)/PI(s) of the NIH application 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 (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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.

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

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

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

See more tips for avoiding common errors.

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

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

For this particular announcement, note the following:

Since a principal goal of this program is to attract and support new ideas, a key feature of this FOA is that preliminary data, unlike as in standard R01 applications, are not required.

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

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

Significance

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

Is the proposed project likely to stimulate collaborative basic, translational, or applied research between U.S.-based researchers and Chinese researchers?

Investigator(s)

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

Innovation

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

Approach

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

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?

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 delays?

Environment

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Not Applicable

Resource Sharing Plans

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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 with consideration of the research priorities of both the NIH and NSFC.

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

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

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: [email protected]

Alan Embry, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-3751
Email: [email protected]

Karl Salzwedel, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-496-5332
Email: [email protected]

Julie Schneider, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5795
Email: [email protected]

Kishor Bhatia, Ph.D., FRCPath
National Cancer Institute (NCI)
Telephone: 301-435-9013
Email: [email protected]

Kendall Bryant, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-9389
Email: [email protected]

Rohan Hazra, M.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6868
Email: [email protected]

Vishnudutt Purohit, D.V.M., Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-594-5753
Email: [email protected]

Jeymohan Joseph, Ph.D
National Institute of Mental Health (NIMH)
Telephone: 301-443-6100
Email: [email protected]

May Wong, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1431
Email: [email protected]

Robert Freund, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1050
Email: [email protected]

Emily Linde
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2943
Email: [email protected]

Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

Bryan Clark, M.B.A.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]

Debra Dudley
National Institute on Drug Abuse (NIDA)
Telephone: 202-722-4093
Email: [email protected]

Rita Sisco
National Institute of Mental Health (NIMH)
Telephone: 301-443-2805
Email: [email protected]

Tijuanna DeCoster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]

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Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.