Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Mental Health (NIMH)
Funding Opportunity Title	Evaluation of the Latent Reservoir in HIV-Infected Infants and Children with Early Antiretroviral Treatment and Virologic Control (R01)
Activity Code	R01 Research Project Grant
Announcement Type	New
Related Notices	February 11, 2013 - See Notice NOT-MH-13-014. Notice of NIMH Participation.
Funding Opportunity Announcement (FOA) Number	RFA-HD-14-026
Companion Funding Opportunity	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.865, 93.855, 93.856, 93.242
Funding Opportunity Purpose	This funding opportunity announcement (FOA) invites grant applications from institutions/organizations that propose to conduct studies of the latent reservoir in HIV-infected children who have had early treatment (antiretroviral therapy initiated at <6 months of age) and have had continuous viral suppression. These studies can be in developed or developing countries. Studies to create new or adapt existing animal models of perinatal HIV infection and early treatment can also be proposed.

Posted Date	February 6, 2013
Open Date (Earliest Submission Date)	July 30, 2013
Letter of Intent Due Date(s)	July 30, 2013
Application Due Date(s)	August 30, 2013, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October/November 2013
Advisory Council Review	January 2014
Earliest Start Date	April 2014
Expiration Date	August 31, 2013
Due Dates for E.O. 12372	Not Applicable

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

This funding opportunity announcement (FOA) invites grant applications from institutions/organizations that propose to conduct studies of the latent reservoir in HIV-infected children who have had early treatment (antiretroviral therapy [ART] initiated at <6 months of age) and have had continuous viral suppression. These studies can be in developed or developing countries. Studies to create new or adapt existing animal models of perinatal HIV infection and early treatment can also be proposed.

In FY 2014, the Office of AIDS Research developed a new scientific research priority area for NIH that targets cure (elimination or functional cure) of HIV infection. However, most studies have focused on the pathogenesis of latent infection in HIV-infected adults and do not take into account the unique factors associated with pediatric HIV infection for example, perinatal infection has an established time of infection; infection is established during a time of immunologic immaturity; there is an active thymus in infants and children; and initiation of therapy can occur within days or weeks of establishment of infection with early diagnosis.

Antiretroviral therapy (ART) fails to eradicate HIV even in patients who suppress the virus to undetectable levels for many years; the existence of persistent HIV infection in certain cellular and anatomical reservoirs is the major hurdle in HIV eradication. The persistence of HIV infection is due to integration of viral DNA into the host DNA of quiescent CD4 T cells where it remains largely inactive (latent) until the cell is activated. Thus, while ART blocks viral replication, these drugs cannot act against latently infected cells in which active viral replication is not occurring. The primary population of cells that harbor the integrated viral DNA (provirus) in patients on effective ART are the extremely long-lived (T =44 months) resting CD4 T cells (i.e. CD69-CD25-DR-), that exist at an approximate frequency of 1 in every 106 resting CD4 T cells. Cell-mediated immune clearance of these latently infected CD4 T cells is limited by the fact that latently infected cells without ongoing active viral replication do not express viral antigens that would render them susceptible to killing by HIV-specific CD4 or CD8 T cells. Additional sites of HIV persistence include macrophages, microglia and astrocytes.

The development of therapeutic interventions that eliminate or limit the latent viral pools or prevent the re-emergence of the viruses from productively infected cells will be required in order to enhance the effectiveness of current ART strategies. To achieve this goal, there is a pressing need to understand HIV latency at the molecular level in order to design novel and improved therapies to either eradicate HIV or find a functional cure in which patients could maintain a manageable viral pool without HIV disease in the absence of ART. This latent reservoir of HIV provirus is established early during the course of HIV infection, and by the time infection is recognized in the majority of adults and older children and treatment can be initiated, the reservoir is well established. This ability to cause latent infection helps HIV to establish a persistent infection despite strong humoral and cellular immune responses against the viral proteins.

The capacity to initiate ART during acute HIV infection in infants distinguishes pediatric HIV-infection from adult infection and provides a model to examine the effects of very early therapy (< 6 months) on establishment and persistence of viral reservoirs. Some children treated during early infancy become HIV-seronegative, losing HIV-specific antibodies and lymphoproliferative responses, and have normal immune function, as reported by Luzuriaga and colleagues in 2000. Thus, they test negative for HIV antibodies by ELISA-and Western blot, are aviremic to levels <50 copies/mL, and may subsequently test negative for HIV DNA by standard methods used to initially identify their infection. Specialized testing with enhanced culture methods and highly sensitive (single copy) RNA and DNA detection methods not used for routine clinical care are required to detect ongoing HIV infection. Additionally, viral diversification has been shown to be substantially limited in infants successfully treated with ART in the first few weeks of life.

Pediatric HIV infection will also provide a unique opportunity to study interruption or diminution of establishment of viral reservoirs with newer therapeutic agents such as integrase or entry inhibitors when given as part of early therapy. Elite treatment responders may be the optimal population for testing novel treatment strategies aimed at purging viral reservoirs, including therapeutic vaccinations and histone deacetylase inhibitors such as SAHA or vorinostat. If viral and host cellular and immune factors and functions required for latency in children can be identified, they can then be targeted for eradication of persistent virus and assist in the development of novel agents and virological, immunological, and cellular therapeutic strategies that could effectively eradicate HIV. These strategies could be effective in HIV-infected adults as well as children and it is possible that proof of principle for cure may first be able to be shown in children.

Evaluation of children who received therapy in the early months of life and have survived for prolonged periods with undetectable plasma viremia could provide clues to the effect of early treatment on latent viral pools. It is possible that children initiating effective ART at very young ages (i.e., = 6 months of age or some other age threshold in infancy) are more likely to have limited HIV reservoirs, decreased immune activation, absent residual viremia and diminished HIV-specific antibody responses compared with those treated at older ages. ART in these infants leads to a unique state of viral persistence whereby control of HIV replication is solely from ART effects as most of these children have little to no HIV-specific cellular immunity. This surviving population of early-treated children presents a unique opportunity to begin studies of this extraordinary state of virus-host interaction arising from early ART. Identification of a composite virologic and immunologic biomarker profile of early successful therapy in children will provide quantitative insights into HIV persistence not under immune control that help define mechanisms of HIV persistence, and also aid with designing and assessing therapeutic strategies aimed at achieving functional cure for this population.

Applicants should propose novel methods for evaluating the latent reservoir and factors associated with such reservoirs in children with perinatal HIV infection who had early treatment and continuous viral suppression. Studies to create new or adapt existing animal models of perinatal infection and early treatment can also be proposed. Appropriate comparison populations should be included as needed for both human and animal studies.

Areas of interest include, but are not limited to:

• Evaluate whether early ART in children affects proviral reservoir size, immune activation, and level of persistent viremia;
• Conduct studies to identify and quantify the tissues and cell types that constitute the persistent viral reservoir in children receiving early ART;
• Evaluate the impact of early infection and treatment on the developing brain;
• Develop tools to measure and quantify HIV in reservoirs such as novel imaging techniques or novel molecular and culture assays appropriate for use in pediatric populations;
• Investigate the role of immune activation, inflammation, and their mediators in various tissues on HIV persistence in infants with perinatal HIV infection;
• Evaluate whether duration of viral suppression after ART, the time from birth until viral suppression is achieved on ART, and/or the timing of infection (in utero, intrapartum, postpartum) is associated with viral reservoir size, ongoing viremia, immune activation, and HIV-specific immune responses in HIV-infected children;
• Identify and validate viral and host cellular factors and functions involved in the persistence of HIV infection despite ART that could be targeted for eradication of persistent virus in HIV-infected children;
• Delineate the viral, host, and immune mechanisms involved in the persistence of HIV infection despite effective antiretroviral therapy (ART), and the establishment and maintenance of the latent viral reservoir in HIV-infected children;
• Host factors (including epigenetics) and viral genetic factors in the establishment and maintenance of HIV-1 persistence in the setting of suppressive ART in children.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The following NIH components intend to commit the following amounts in fiscal year 2014: NICHD intends to commit $1,500,000 total costs to fund 3-6 awards. NIAID intends to commit $1,400,000 total costs to fund 3-6 awards. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations.
Award Budget	Budgets up to $750,000 direct costs per year may be requested.
Award Project Period	The scope of the award should determine the project period. The maximum period is 5 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.

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)

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

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

Applicant organizations must complete the following registrations as described in the SF424 (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.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• Grants.gov
• eRA Commons

All Program Directors/Principal Investigators (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 6 weeks prior to the application due date.

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 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.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for 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, 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 research
• 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:

Rohan Hazra, MD
Maternal and Pediatric Infectious Disease Branch (MPIDB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)
6100 Executive Boulevard, Room 4B11
Bethesda, MD 20892
Rockville, MD 20852 (for express/courier service; non-USPS service)
Telephone: 301-435-6868
Email: [email protected]

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.

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

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

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.

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

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the 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 before the deadline 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.

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 theSystem for Award Management (SAM). 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-10-115.

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.

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? How does the study address the priority research area of identification, quantitation and factors associated with the latent HIV reservoir in children with perinatal HIV infection with early treatment?

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? Are the researchers experienced in the conduct of studies in pediatric patients?

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? Does the project incorporate new approaches to answer questions related to the latent reservoir in children with perinatal HIV infection with early treatment?

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? Does the strategy take into account limitations on blood sampling in small children? Are the laboratory assays appropriate and have they been validated for use with limited samples available in children?

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?

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? Do the investigators demonstrate that they have access to the appropriate population for study (children with perinatal HIV infection who initiated therapy at <6 months of age with virologic suppression)?

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 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

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

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

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the NICHD, 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 National Advisory Child Health and Human Development (NACHHD) Council. l The following will be considered in making funding decisions:

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

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

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

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]

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

Joseph E. Fitzgibbon, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-451-2738
Email: [email protected]

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-1485
Email: [email protected]

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-1485
Email: [email protected]

Ann Devine
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301- 402-5601
Email: [email protected]

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

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