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), Consortia for Innovative AIDS Research in Nonhuman Primates, represents a continuation of the Consortia for AIDS Vaccine Research in Nonhuman Primates http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-10-004.html, with an expansion to HIV cure efforts by applying lessons learned in preventive NHP vaccine research and immunology. The FOA solicits complex, large-scale research activities within a Consortium to investigate the mechanism(s) by which efficacious AIDS vaccines protect nonhuman primates (NHP), and to investigate cure strategies that incorporate vaccines or other immune interventions. Applicants, having demonstrated efficacy of a vaccine that blocks infection at the portal of entry, or prevents establishment of localized infection, or impedes the spread of infection to lymphatic tissue, or prevents sustained systemic infection with SIV/SHIV, will propose a research program to identify the site(s) and mechanism(s) of action whereby this vaccine exerts its protective effect. In addition, this FOA supports research including immune interventions as part of a strategy aimed at eliminating SIV/SHIV proviral reservoirs or leading to sustained remission after discontinuation of highly active antiretroviral therapy (HAART) in NHP.

Each Consortium should propose integrated research both on the mechanism(s) of the preventive vaccine(s) and on the use of vaccines or other immune modalities in advancing cure research. The primary focus of the application should be on vaccine research, and the secondary focus should be on cure research.

Prevention of HIV and cure from HIV infection are the two highest priorities of the Division of AIDS (DAIDS) at the National Institute of Allergy and Infectious Diseases (NIAID). These research priorities remain challenging because of two HIV characteristics: 1) the error-prone reverse transcriptase rapidly generates sequence diversity that poses a challenge to the development of vaccines and therapies, because an HIV vaccine needs to protect against many different antigenic variants of circulating viruses and drug-resistant mutants that can arise in treated individuals and 2) the ability of HIV to integrate and become undetectable in latent form hinders cure efforts.

For the DAIDS vaccine priority, the RV144 phase 3 trial was a modest step forward. Although it provided evidence that development of an efficacious vaccine may be possible, improvement of HIV vaccines is urgently needed. Several vaccines have shown partial efficacy against mucosal challenge in NHP trials, either by reducing the acquisition risk per individual exposure in a repeat-exposure model or by completely eliminating persistent infection in a portion of the vaccinated animals. The mechanism of protection presumably reflects an interplay of factors (e.g., inflammatory status of the host and immune response to the vaccine) that delay or abolish SIV/SHIV infection. Some correlates of immunity have been deduced from many such NHP experiments, and two immune correlates of risk of infection were also inferred from the RV144 efficacy trial. However, no assay measuring these correlates accurately predicts which animals will be protected (after challenge in NHP experiments), and a prospective test of the human correlates of risk awaits the outcome of the upcoming efficacy trials of the RV144-based regimen in South Africa. A better understanding of the factors that distinguish protected from unprotected animals, as well as assays that accurately predict which vaccinees will be protected, is urgently needed to help guide the improvement of HIV vaccine design and prioritize next-generation vaccines for large-scale human trials.

In treated individuals, HIV replication can be suppressed for many years to several decades, but the virus cannot be eliminated with current therapies; it invariably rebounds rapidly upon cessation of HAART. A single exception is one individual, who received two stem cell transplants from a delta32 CCR5 homozygous donor and is considered cured of HIV. In several other infected individuals, including an infant and two bone marrow transplant patients, HIV infection went into long-term remission before the virus re-emerged. Although sterilizing cure is the ultimate goal, an alternative, intermediate aim may be to achieve sustained viral remission by controlling HIV replication through combination strategies including immune-based therapies.

NHP models are uniquely suited to mechanistic studies because they offer the advantage of testing novel vaccine and therapeutic concepts without causing harm to human subjects and because they allow for extensive and invasive sampling of tissues. To prevent acquisition, the vaccine-induced immune responses must restrict expansion of a small number of invading founder viruses. Similarly, sustained viral remission must inhibit the re-emergence and spread of viruses that occur after HAART is stopped. Conceptually, similar broad and potent immune responses needed for a successful prophylactic vaccine, when induced in infected individuals under HAART, could control HIV replication after discontinuation of antiretroviral therapy.

The research objectives of this FOA are two-fold: to identify the nature, location and timing of immune responses that protect against mucosal SIV/SHIV exposure and to employ combination strategies that inform future studies on HIV cure. Each applicant is expected to propose a plan that primarily addresses mechanisms of vaccine prevention and also proposes an additional, secondary focus on cure research. The NHP model employed needs to be appropriate for the intervention studied. For example, at least one vaccine proposed for study must have previously demonstrated partial protection against a SIV/SHIV mucosal route of exposure. Although the main emphasis of research should be based on models using intravaginal transmission, additional studies using intrarectal and/or penile infection models may also be included. For cure approaches, the SIV/SHIV load must be able to be suppressed with the proposed combination antiretroviral therapy (cART) regimen and rebound, in control animals, after discontinuation of cART to pre-cART level. All cure approaches must be combined with highly suppressive cART. For optimal utilization of the valuable NHP resource, the FOA encourages the re-use of animals (SIV/SHIV-positive or negative) from completed vaccine studies in the cure studies.

It is expected that existing assays will be used to quantify viral load and the viral reservoirs and also to assess immune responses, especially in SIV/SHIV target tissues. Assays may be improved/refined, but are not to be developed de novo to accomplish the research aims. The proposed research teams should have demonstrated expertise in SIV/SHIV biology and molecular biology, NHP immunology, mucosal immunology, virology, cellular biology, and the technologies needed to conduct the investigations requested under this FOA.

Examples of vaccine research include, but are not limited to, the study of

A) Basic biology of early events after challenge, in the context of vaccination

• Cross-talk between innate and adaptive immunity at mucosal sites
• Host factors (e.g., FcR genotypes)
• Innate responses that can be elicited upon subsequent infection

B) Early sites of infection and extent of vaccine inhibition of infection by

• Blocking viral attachment and infection
• Blocking local virus spread
• Mobilization of cells to the mucosal site of infection
• Recruitment and/or mechanisms of protection from infection of new target cells
• Inhibition of virus spread to draining lymph nodes and secondary lymphoid organs
• Characteristics of break-through viruses

Examples of cure research include, but are not limited to, the study of

A) Combinations of vaccine(s) with HAART and other interventions

B) Immune-based strategies that enhance clearance or limit replenishment of reservoirs

• Therapeutic use of vaccines +/- immunomodulators
• Target cell depletions +/- immunomodulators
• Engineered T-cells, chimeric antigen receptors (CARs)
• Harnessing the power of effector cells, cytotoxic T lymphocytes, and regulatory pathways for immunotherapy
• Mono- or bi-specific antibodies as recombinant proteins or delivered as genes by expression vectors

C) Innovative delivery strategies with specificity for viral reservoirs

• Targeted delivery to viral sanctuary sites
• Improved viral vector deliveries
• Highly sensitive imaging methods of the delivered therapeutic agents and HIV reservoirs

Data for the safety and tolerability of each cure approach should be collected at the same time as the efficacy studies involving the veterinary team.

If applicable, the studies should include a balance of female and male NHP. See also NOT-OD-14-128.

The following will be considered non-responsive and will not be reviewed:

Research that fails to both: 1) identify the site(s) and mechanism(s) of action whereby the vaccine(s) exerts its protective effect and 2) include vaccines or other immune interventions as part of a strategy to eliminate SIV/SHIV proviral reservoirs or provide a sustained remission after discontinuation of highly active antiretroviral therapy (HAART) in NHP. However, the study of additional non-vaccine interventions to affect the viral reservoir is permitted.

• Applications that propose use of NHP facilities that are not Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC)-accredited
• Descriptive studies without clear focus on mechanism of action
• Natural host SIV models (i.e., SIV-infected African-origin monkey species)
• Natural history studies not related to acute/early infection events
• Development of NHP models only (although model development can be a part of the research foci)
• Studies only measuring responses in blood without corresponding studies in tissues
• Studies with a major focus on probiotics
• Oral routes of virus exposure/infection
• Mother-to-infant transmission of virus
• Studies that propose intensified HAART only
• Studies that only propose imaging or characterization of the viral reservoirs

Note: The NHP consortia will have access to DAIDS support contracts for NHP viremia assays, NHP antiviral antibody assays and NHP cellular immune response assays, as capacity permits and as recommended by DAIDS staff.

Consortium research must be an integrated program, even if the contributing and collaborating scientists are from different laboratories and institutions.

Each Consortium must contain Operations and Management Support (OMS) and may also include Scientific Research Support Cores to support and achieve Specific Aims. The OMS will serve as a resource to the entire Consortium, providing overall management, coordination, and supervision of the Consortium, including adherence to the timelines. Scientific Research Support (Cores) may be necessary to support the science and provide resources to the program. Examples of Support Sections could be: virology, NHP facility, immunology, systems biology, statistical support, etc.

This FOA encourages New Investigators, and in particular Early Stage Investigators, to participate in this research 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)

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

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

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

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

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

Applicants must 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:

Peter R. Jackson, Ph.D.
Telephone: 240-669-5049
Email: pjackson@niaid.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

The Research Strategy should consist of the following sub-sections with the indicated page limits:

• NHP Consortium Overview Section: one required - 12 pages
• NHP Research Program Section: one required (vaccine and cure part combined) - 30 pages
• Operation and Management Support Section: one required - 12 pages
• Scientific Research Support Sections (Cores): optional, up to 6 maximum 6 pages each

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: For the Scientific Research Support Sections include a description of how the scientific environment in which the service or resource will be conducted contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport).

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

Biosketches for proposed Key Personnel should demonstrate expertise in SIV/SHIV biology and molecular biology, NHP primate immunology, mucosal immunology, virology, or cellular biology.

The involvement of a medical doctor actively managing HIV cure clinical trials is strongly encouraged.

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

• Travel funds may be requested for attendance of one scientific meeting per year by the PD(s)/PI(s) and one meeting per year by each senior key personnel.
• Travel funds for the PD(s)/PI(s), other key NHP Consortium personnel, and Scientific Advisory Board (SAB) members to attend a Kick-Off meeting and annual NHP Consortium meetings should be included.
• Travel for other operational activities, such as special meetings of the SAB, may also be requested with appropriate justification.
• Funding for the overall administrative efforts should include secretarial, and/or other administrative services, expenses for publications demonstrating collaborative efforts, and communication expenses.
• Applicants are encouraged to identify and budget for staff and a program manager to manage daily operations and communication within the NHP Consortium.

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: List in priority order the broad overarching long-range objectives and goals of the proposed NHP Consortium program. Concisely and realistically describe the hypothesis or hypotheses to be tested. The Specific Aims should emphasize HIV vaccine research with a secondary focus on HIV cure research.

Research Strategy: The Research Strategy must consist of the following clearly labeled sub-sections uploaded as a single attachment:

A. NHP Consortium Overview Section

This narrative section summarizes the overall research strategy for the application and contains the NHP Consortium Research Strategy and its Strategic Plan.

Consortium Research Strategy: The NHP Consortium application should be viewed as a constellation of interrelated and complementary research efforts. This is an important section because it provides the group of investigators with an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the identified problem.

Describe the integration of the overall program, and how it establishes an iterative approach to the mechanistic HIV vaccine study and cure strategies; each activity within the NHP Consortium should be cited briefly as to its relation to the overall scheme. Discuss how their contributions in terms of expertise provided and special resources will advance the research strategy and overarching objective(s) of the NHP Consortium program.

Strategic Plan: The Overview section of the application must also include a Strategic Plan that details the scientific goals, and proposed scope of activities for the NHP consortium. Define criteria for success for both the vaccine and cure studies. For the cure studies, develop milestone and Go/No-go criteria. The cure studies could be a follow-on to the vaccine studies using the same NHP where possible. The Strategic Plan should identify three to five investigators who will constitute the initial Executive Committee (EC) of the NHP consortium. These individuals may also be investigators in initial Research or Scientific Research Support Sections.

The Strategic Plan should include a detailed delineation of the processes for:

• Setting scientific priorities
• Allocation of resources
• Monitoring and evaluating progress and performance toward scientific goals
• Redirecting scientific focus, including reallocation of funds
• Augmenting research plans to implement the Scientific Agenda as necessary to capitalize on new scientific opportunities
• Discontinuing, temporarily or permanently, the services of subcontractors, and terminating or curtailing research activities, including Research Foci or Scientific Support Sections described in the application, if they become no longer scientifically justified in the context of the Scientific Agenda of the NHP Consortium
• Changing Executive Committee membership to add or remove expertise if required
• Criteria and process for nominating Scientific Advisory Board (SAB) members as described in Award Requirements Section VI.2. Areas of Joint Responsibility below. Note that proposed members of the SAB are not to be named in the application.

B. NHP Research Program Section

The application must propose at least two Research Foci in a single, unified NHP Research Program Section. These Foci must concentrate on

(1) the mechanism by which a protective vaccine blocks persistent infection, with possible sub-aims such as: (a) T cell responses of specific quality/duration that can effectively limit virus replication, (b) innate responses that can be manipulated to augment or accelerate virus suppression (e.g., NK cell subsets), (c) other areas of research directly relevant to prophylactic HIV vaccine design, and

(2) HIV cure strategies by utilizing anti-HIV immune responses such as:

a) Combinations of vaccine(s) with HAART and other interventions

b) Immune-based strategies that enhance clearance or limit replenishment of reservoirs

• Therapeutic use of vaccines +/- immunomodulators
• Target cell depletions +/- immunomodulators
• Engineered T-cells, chimeric antigen receptors (CARs)
• Harnessing the power of effector cells, cytotoxic T lymphocytes, and regulatory pathways for immunotherapy
• Mono- or bi-specific antibodies as recombinant proteins or delivered as genes by expression vectors

c) Innovative delivery strategies with specificity for viral reservoirs

• Targeted delivery to viral sanctuary sites
• Improved viral vector deliveries
• Highly sensitive imaging methods of the delivered therapeutic agents and HIV reservoirs

The Research Foci should include multi-pronged approaches to understanding vaccine function and approaches for a functional cure. However, the application should not attempt to cover all conceivable areas of possible research with separate Research Foci from the start of the award period, to allow for flexibility in growing and changing research direction to explore areas of new technologic opportunities. The Research Program should explain how the proposed Research Foci and future possible Research Foci fit within the overall Scientific Agenda presented in the Overview section of the application. It should clearly explain how each Research Focus implements the research vision and is integral to the Scientific Agenda.

Consortium Research Strategy (by Research Focus): Within the Consortium Research Section, list in priority order, the broad, long-range objectives and goals of each proposed research focus. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the relationship of the Research Focus to the complex program goals and how it relates to other research foci or support components. Use this section to describe how the proposed research (focus by focus) will contribute to meeting the consortium's goals and objectives and explain the rationale for selecting the methods to accomplish the Specific Aims. In addition to stating the biological significance of the research, indicate the project's relevance to the Scientific Agenda of the application. Applicants should clearly describe how the proposed NHP cure strategies could be moved to a phase I clinical trial without major conceptual changes or if basic NHP cure research is proposed, how it significantly advances scientific knowledge.

Milestones and timelines should be placed at the end of the Research Strategy section. Any Milestones and Go/No-Go decision points should not be a restatement of the application’s Specific Aims, but a quantifiable description of the outcome of the vaccine and cure studies. Describe plans to address success or failure to achieve milestones and Go/ No-Go criteria and describe how futility will be addressed. Use Gantt charts if necessary to document the timelines.

C. Operation and Management Support Section (OMS)

Describe how the OMS will oversee NHP Consortium communications, i.e., group meetings, teleconferences, and establish policies for presentations at scientific meetings, and publication of results.

Describe how the OMS will oversee the day-to-day administrative operations of the NHP Consortium and provide leadership for the program. Describe and justify staffing of this Section to support its role in the NHP Consortium operations. Describe the activities needed to demonstrate its potential for leadership by describing the processes and procedures that enable routine administrative actions and activities.

Describe how the OMS will organize and support a face-to-face Kick-Off meeting within three months of award and annual meetings thereafter.

Describe how the OMS will coordinate internal sharing of information and shipping of reagents.

Describe the formation and operations of the Executive Committee (EC; composed of key NHP Consortium personnel and the assigned NIAID Program/Project Officer and the PD/PI). The EC is expected to convene monthly using telecommunication resources for sharing of NHP consortium progress. Describe how the EC will evaluate progress and overall functioning of the NHP consortium award and the methods it will use to follow-up on and resolve action items.

D. Scientific Research Support Sections (Cores)

These sections of the application should present a clear picture of the techniques and skills that each research support section will provide and describe the role of the Scientific Research Support Section Leader and each of the key participants.

Repeat this section for each Support Section (Core) proposed. If proposing more than one Support Section, identify each of them with a number and title and indicate which required or optional section they will support.

The Support Section must be well justified and clearly non-duplicative of other services or facilities available to the Consortium investigators. Scientific Support Sections cannot be used to circumvent the page limit of any of the required sections.

Describe how the proposed Scientific Support Section activities will contribute to meeting the Consortium goals and objectives and explain the rationale for selecting the general methods and approaches proposed to accomplish the Specific Aims. Describe the Scientific Support Section activities, emphasizing their provision of shared resources that do not overlap or duplicate other activities in the Consortium application.

Describe the facilities, techniques, and skills that the core will provide to Consortium activities with specific quantifiable and scientifically justified milestones. Identify the role of the Scientific Support Section key participants in providing the core’s service to the overall award.

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

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

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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 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. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

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

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

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

Does the project address an important problem or a critical barrier to progress in the field? 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?

Can the proposed cure strategy be moved to a phase I clinical trial without major conceptual changes or if basic NHP cure research is proposed, does it significantly advance scientific knowledge?

Is the overall Consortium compelling, with clear rationale for the proposed approaches and areas of focus? How well do the overall Consortium goals, expressed in the Scientific Agenda and Strategic Plan, address important roadblocks to the discovery and development of a safe and effective strategy for HIV vaccines and for eradication of HIV reservoirs and persistent infection? Are the individual Research Foci scientifically meritorious?

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? How likely is it that the partnerships and collaborations involved will lead to critical new knowledge about HIV vaccines and the HIV cure?

Does the PD/PI have documented leadership and management experience with large, complex, multidisciplinary research collaborations? Will the PD/PI and other key investigators involved devote adequate time and effort to the program? Is there a sound plan to manage changes in research priorities and resource allocation, and to incorporate new partnerships and collaborations as needs arise?

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 proposed research lead beyond the approaches that already have been tried and published? Is a clear decision-making process in place to allow shifts in research focus and/or funding allocation to maintain innovation as the research evolves? Is the cure approach based on state-of-the-art science and are alternate plans proposed?

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?  Is the overall Consortium compelling, with clear rationale for the proposed approaches and areas of focus?

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?

Have the proposed vaccine(s) demonstrated at least partial protection?

Has the valuable NHP resource been optimally utilized (e.g., re-use of NHP from completed vaccine studies in cure studies where feasible)?

Is the Strategic Plan feasible and compelling as a way to implement the Consortium Research Strategy? Is there synergy among the individual research sections and support sections toward the central objectives of the program? Are the approaches proposed in the Strategic Plan coherent and focused on an important aspect of HIV vaccine or cure discovery research? Does the Consortium Research Strategy integrate both SIV/SHIV vaccine and cure studies?

Are there appropriate plans and mechanisms for budgetary reallocation and for selecting, reviewing and adding new activities and recruiting new Research Foci and Support Section Leaders? Are there appropriate and feasible plans to incorporate new research activities and/or scientific resources/facilities in response to emerging opportunities or to eliminate unproductive research and/or resources/facilities? Are the proposed milestones, Go/No-Go criteria and metrics to monitor, quantify and evaluate progress and productivity appropriate and feasible?

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?

Is the environment appropriate for housing large numbers of NHP? Does the institution have experience with large size NHP studies? Is equipment for the proposed animal procedures available? Does the institution employ experienced veterinarians and animal technicians? Are the animal personnel trained in the proposed procedures? Does the institution have access to in vitro laboratories with equipment to process and analyze the NHP samples? Are the logistics of shipping NHP samples between multiple sites reasonable and manageable?

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

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

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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.

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

Not Applicable

Not Applicable

Not Applicable

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

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.

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

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

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 National Institute of Allergy and Infectious Diseases, 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:

• 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 Allergy and Infectious Diseases Council. 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 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

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies. 

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below. 

The PD(s)/PI(s) will have the primary responsibility for:

• integrating and implementing the recommendations of the SAB into the NHP Consortium program.
• assuring compliance of the NHP Consortium program with all applicable Federal, State, Local, regulations, and all applicable DHHS/NIH/NIAID/DAIDS policies for conduct of research.
• organizing and hosting a Kick-Off and annual NHP Consortium meeting attended by scientific key personnel, SAB members, other key NHP Consortium members, and NIAID staff. The PD(s)/PI(s) and other NHP Consortium members shall present for the Kick-Off meeting, the proposed Research Plan, milestones, Go/No-Go decision points and time lines with the goal of informing and obtaining SAB input on the NHP Consortium immediate plans for oversight and initiation of the research. For annual meetings the PD(s)/PI(s) and other NHP Consortium members shall present: (1) an update on the results achieved for each strategy or section of the NHP Consortium proposal, (2) a review of progress in meeting the Research Plan, milestones and Go/No-Go criteria within the previous year, (3) discussion of scientific, technical and other problems and obstacles encountered and the methods/approaches proposed or implemented to overcome and/or resolve obstacles and problems, and (4) future plans for achieving remaining milestones, address identified or potential problems that may impede or slow progress, and propose methods/approaches for resolving such problems, including contingency plans for delays, acceleration of timelines, and/or modifications to established milestones and timelines.
• Intellectual Property: To this end, all awardees shall understand and acknowledge the following:
  • The PD(s)/PI(s) and the applicant institution are solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the applicant to perform the project.
  • Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project.
• Publications: The PD(s)/PI(s) will be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by project investigators and supported in whole or in part under this Cooperative Agreement. The PD(s)/PI(s) and key persons are requested to submit manuscripts to the NIH Project Scientist after acceptance for publication so that an up-to-date summary of program accomplishments can be maintained. Publications and oral presentations of work conducted under this Cooperative Agreement are the responsibility of the PD(s)/PI(s) and appropriate key personnel and will require appropriate acknowledgement of NIH support. Timely publication of major findings is encouraged.

NIH staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

• The NIH Project Scientist will provide appropriate assistance, advice, and guidance by: participating in scheduled meetings and teleconferences that may include, but are not limited to, EC meetings and teleconferences to discuss program coordination and/or progress; participating in Kick-Off and annual meetings and SAB deliberations; participating in the design of the activities; facilitating collaboration with other NIH-supported research resources; and advising in project management and technical performance. The role of the NIH Project Scientist will be to facilitate and not to direct the activities. It is anticipated that the NIH Project Scientist, other NIAID staff identified by the PD(s)/PI(s), and/or the Executive Committee, and/or others having relevant expertise may be given the opportunity to offer advisory input. The NIH Project Scientist will facilitate liaison activities for partnerships, and provide assistance with access to NIH-supported resources and services.
• The NIH Project Scientist, with the support of appropriate staff and expertise, will provide coordination and assistance to the awardee to meet the Division of AIDS requirements for animal protocol content. Other appropriate NIH program staff may include veterinarians, medical officers, regulatory staff and other expertise as required. NIAID reserves the right to terminate or curtail an animal study in the event of (a) substantial shortfall in animal study conduct, data reporting, quality control, or other major breach of the animal protocol, (b) substantive changes in the animal protocol to which the NIAID does not agree, (c) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (d) vertebrate animal ethical issues that may dictate a premature termination.
• The Government, via the NIH Project Scientist, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards.
• The assigned agency program official or IC program director may also serve as an NIH Project Scientist.
• An agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Areas of Joint Responsibility include:

• Executive Committee (EC)
  • Establish an EC within one (1) month following award of the grant.
  • The EC will be housed in the Operations and Management Section and support its administrative oversight function for the NHP Consortium. The EC will consist of the designated senior key persons for each Section, the NIH Project Scientist, other NIH scientists as identified by the PD(s)/PI(s) and/or EC, and any other key personnel identified by the PD(s)/PI(s). The EC may add additional members by majority vote, and each full member will have one vote. The NIH Project Scientist will participate in the activities of the EC as a non-voting member, providing verbal or written responses to the EC or its designated subcommittees upon request. 
  • The EC will act to enable and implement policies approved by the EC, and will serve as the main day-to-day administrative governing board of the NHP Consortium.
  • The EC will assist the PD(s)/PI(s) in achieving the goals of the NHP Consortium program, create subcommittees, evaluate progress of the NHP Consortium and make recommendations for achieving milestones and implementing Go/No-Go decisions. This may include recommending alterations in the level of effort for specific Strategies and/or Sections, such that efforts may be terminated to allow more productive avenues of development to proceed.
  • The EC will assist the PD(s)/PI(s), as required, in implementing SAB recommendations and preparing formal reports summarizing NHP Consortium activities and/or progress as needed. The EC will also advise the NIH Project Scientist on scientific opportunities, emerging needs and impediments.
  • The EC will advise on implementation of the Research Plan, Milestones and Go/No-Go decisions. The EC will assist the PD(s)/PI(s) and NIH Project Scientist in prioritization of products and research efforts. The EC will also assist the PD/PI and other key personnel in animal study protocol development and vertebrate animal welfare issues as needs arise.
• NHP Consortium Scientific Advisory Board (SAB)
  • The NHP Consortium leadership (Executive Committee and/or PD/PI) will establish an SAB of at least three investigators not affiliated with any of the institutions participating in the NHP Consortium research program. The SAB will be part of the Research Section and will assist the NHP Consortium PD/PI in the scientific administration of the award.
  • SAB membership will be identified in consultation with the NIH Project Scientist, and the SAB should be constituted within three (3) months following award.
  • The members of the SAB are expected to attend the Kick-Off meeting and the NHP Consortium annual meetings during the award period.
  • The SAB members in attendance at annual meetings will assist in review of the NHP Consortium activities and evaluate progress and assess the continued relevance of each activity to the overall goals of the research program. The SAB may recommend new directions as appropriate and will provide the PD(s)/PI(s) with a comprehensive written evaluation of their recommendations after the annual meeting, if required by the NIH Project Scientist or the PD/PI.
  • In the rare event that members of the SAB are not present at annual meetings, the PD/PI will create a summary of the meeting and provide the absent members a list of action items and recommendations of the SAB members in attendance and then facilitate communication of the absent members opinions to the EC and other members of the SAB.
  • The SAB may be called upon to evaluate the overall progress of NHP and of the individual vaccine and cure sections. The SAB may also make recommendations, which products should advance or be discontinued.
  • The SAB, at the discretion of the PD/PI and/or NIH Project Scientists, may be consulted to evaluate the timing and feasibility of initiating an animal vaccine or cure study.
• The Research Plan, milestones, Go/No-go decisions, timelines and Gantt charts proposed by the PD(s)/PI(s) shall be referenced in the terms and conditions of award. It is recognized that these may require revision and re-negotiation during the project period. The PD(s)/PI(s) and NIAID must agree to all such revisions.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Executive Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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

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

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

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

eRA 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: commons@od.nih.gov

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

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

Alan Schultz, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-6169
Email: schultzam@mail.nih.gov

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

James Bradac, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-3754
Email: jbradac@niaid.nih.gov.

Peter R. Jackson, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (240)669-5049
Email: pjackson@niaid.nih.gov

Jorge Machuca
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2981
Email: jorge.machuca@nih.gov

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

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