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Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute of Allergy and Infectious Diseases (NIAID)
National Cancer Institute (NCI)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

U.S.-China Program for Biomedical Collaborative Research (R01)

Activity Code

R01 Research Project Grant

Announcement Type

New

Related Notices

  • August 28, 2012 - See Notice NOT-AI-12-049. The purpose of this notice is to clarify the budget submission requirements.

Funding Opportunity Announcement (FOA) Number

RFA-AI-12-021

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.855, 93.856,93.393, 93.394, 93.395, 93.396, 93.242, 93.853

Funding Opportunity Purpose

The purpose of the U.S.-China Program for Biomedical Collaborative Research is to stimulate collaborative basic, translational, and applied 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, Parkinson’s disease (PD), and stroke.

Key Dates
Posted Date

April 4, 2012

Open Date (Earliest Submission Date)

August 18, 2012

Letter of Intent Due Date

August 18, 2012

Application Due Date(s)

September 18, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

January, 2013

Advisory Council Review

May, 2013

Earliest Start Date(s)

August, 2013

Expiration Date

September 19, 2012

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

The purpose of the U.S.-China Program for Biomedical Collaborative Research is to stimulate collaborative basic, translational, and applied research between 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, Parkinson s disease (PD), and stroke.

Background

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 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, will develop strategic plans for collaboration, review and clearance of proposed U.S.-China projects. 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.

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.

Scope of the Research Supported under this FOA:

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, cancer, mental health, Parkinson’s disease (PD), and stroke.

NIAID -Immunology (non-HIV/AIDS):

Host immune response and/or regulation of the inflammatory 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:

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:

NCI - Cancer:

In the area of cancer research, applications need to address cancer in the context of infectious agents and/or diseases.

Note: Applications that propose to study cancer only and do not have an infectious agent and/or disease component will be considered nonresponsive and will not be reviewed.

Research focused on the links between infection and cancer important in the U.S. and China, particularly:

Research on infection-related cancer areas include, but are not limited to:

NIMH - Mental Health:

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

Research focused on risk and resilience for mental disorders within a developmental framework, including:

NINDS - Research on Parkinson’s disease (PD) and stroke include

The NINDS will support novel collaborative research projects in the areas of Parkinson’s disease (PD) and stroke. Research topics include, but are not limited to:

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

HIV/AIDS:

HIV/AIDS and its 1) co-infections including, tuberculosis, and hepatitis C and hepatitis B; and 2) complications associated with long-term HIV disease and antiretroviral therapy, including AIDS-defining and non-AIDS defining malignancies, metabolic disorders, cardiovascular disease, conditions associated with aging, and neurologic and neurocognitive disorders.

Research toward a cure for HIV/AIDS including studies on: HIV reservoirs, latency, and persistence; screening and testing of novel compounds; developing and testing novel approaches combining virologic-, immunologic-, and cellular-based therapies, as well as strategies to activate latent virus; and adherence to treatment regimens, as well as research at the individual, community, and population levels on developing and implementing a cure for HIV/AIDS.

Research studies on the epidemiologic impact of HIV on tuberculosis, pathogenic interactions between HIV disease and tuberculosis, including, but not limited to:

Research on 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.

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.

Applicants should clearly describe the specific aims of the project and the roles and responsibilities of the U.S. PD(s)/PI(s) and NFSC collaborative partners in accomplishing the proposed research. The description of the collaborative research, detailing the integration of the U.S. and Chinese collaborative 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 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.

Since a principal aim of this FOA 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 for this R01 submission.

Scope of research or activities NOT supported under this FOA:

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.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

Issuing ICs and partner components intend to commit an estimated total of $5.0 million to fund 4-8 awards per IC in FY13.

Award Budget

Application budgets are limited to $200,000 per year in total costs over a three year period.

Award Project Period

Scope of the proposed project should determine the project period. The maximum period is 3 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

Foreign Institutions

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.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (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.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

The letter of intent should be sent to:

Priti Mehrotra, M. Sc., Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
For Express Couriers: 20817-1824
Phone: 301-435-9369, 301-496-2550
Fax: 301-480-2408
Email: [email protected]

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Cover Letter Component

Applicants should clearly indicate in the Cover Letter the corresponding area of science proposed in their application as outlined in the "Scope of Research Supported under this FOA" and their preference for IC referral for peer review.

Note: Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by National Institute of Allergy and Infectious Diseases, National Cancer Institute, National Institute of Mental Health, and National Institute of Neurological Disorders and Stroke based on research areas.

Modular Budget Component

Applicants should include only budget information for the activities for which they are requesting NIH funds. Do not include budget information for activities requested from the corresponding NSFC application through the NSFC.

PHS 398 Research Plan Component

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

Research Strategy

Included within the 12 page limit of the Research Strategy Section:

Applicants should 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. 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 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.

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 should include a Letter of Support co-written and co-signed by the PD(s)/PI(s) of the "parent" 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:

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.

Foreign Institutions

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

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

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

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

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 SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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.

Overall Impact

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

Scored Review Criteria

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(s)/PI(s), 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 clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? 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?

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?

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

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.

Additional Review Considerations

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

Applications from Foreign Organizations

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

Select Agent Research

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by National Institute of Allergy and Infectious Diseases, National Cancer Institute, National Institute of Mental Health, and National Institute of Neurological Disorders and Stroke in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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.

Section VI. Award Administration Information

1. Award Notices

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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

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.

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]

Scientific/Research Contact(s)

National Institute of Allergy and Infectious Diseases:

Lara Miller
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
301-496-7551
[email protected]

Polly Sager
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases (NIAID)
301-496-1884
[email protected]

Emily Erbelding
Division of Acquired Immunodeficiency Syndrome
National Institute of Allergy and Infectious Diseases (NIAID)
301-435-3384
[email protected]

National Cancer Institute:

Geraldina Dominguez
Office of HIV and AIDS Malignancies
National Cancer Institute (NCI)
301-496-3204
[email protected]

Robert Allan Mufson
Division of Cancer Biology
National Cancer Institute (NCI)
301-496-7815
[email protected]

Elizabeth Read-Connole
Division of Cancer Biology
National Cancer Institute (NCI)
301-496-9740
[email protected]

Gary L. Ellison
Division of Cancer Control and Population Sciences
National Cancer Institute (NCI)
301-402-1853
[email protected]

National Institute of Mental Health:

Phuong Kim Pham
Office for Research on Disparities and Global Mental Health
National Institute of Mental Health (NIMH)
301-443-3724 (P)
[email protected]

National Institute of Neurological Disorders and Stroke:

Yuan Liu
Chief, Office of International Activities
National Institute of Neurological Disorders and Stroke (NINDS)
301 496-0012
[email protected]

NIH Office of AIDS Research:

Robert Eisinger
Office of AIDS Research (OAR)
301-496-0358
[email protected]

Peer Review Contact(s)

National Institute of Allergy and Infectious Diseases:

Priti Mehrotra
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases (NIAID)
301-435-9369, 301-496-2550
[email protected]

National Cancer Institute:

Eun Ah Cho
Division of Extramural Activities
National Cancer Institute (NCI)
301-435-1822
[email protected]

National Institute of Mental Health:

David Armstrong
Division of Extramural Activities
National Institute of Mental Health (NIMH)
301-443-3534
[email protected]

National Institute of Neurological Disorders and Stroke:

Chief, Scientific Review Branch
National Institute of Neurological Disorders and Stroke
Telephone: (301) 496-9223
[email protected]

Financial/Grants Management Contact(s)

National Institute of Allergy and Infectious Diseases:

Maggie Wells
Grants Management Program
National Institute of Allergy and Infectious Diseases (NIAID)
301-594-9847
[email protected]

National Cancer Institute:

Crystal Wolfrey
Deputy Director
Office of Grants Administration
National Cancer Institute (NCI)
301-496-8634
[email protected]

National Institute of Mental Health:

Rebecca Claycamp
Chief, Grants Management Officer
National Institute of Mental Health (NIMH)
(301) 443-2811
[email protected]

National Institute of Neurological Disorders and Stroke

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

Section VIII. Other Information

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.

Authority and Regulations

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



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