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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov)

Title: Recovery Act Limited Competition: Protection of Human Health by Immunology and Vaccines (U01, U19)

Announcement Type
New

Update: The following update relating to this announcement has been issued:

Request For Applications (RFA) Number: RFA-AI-09-040

Catalog of Federal Domestic Assistance Number(s)
93.701

Key Dates
Release Date: June 2, 2009
Letters of Intent Receipt Date(s): September 15, 2009
Application Receipt Dates(s): October 15, 2009
Peer Review Date(s): February, 2010
Council Review Date(s): May, 2010
Earliest Anticipated Start Date: June, 2010
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/qa/revniaid.htm
Expiration Date: October 16, 2009

Due Dates for E.O. 12372

Not Applicable.

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement Terms and Conditions of Award
1. Principal Investigator Rights and Responsibilities
2. NIH Responsibilities
3. Collaborative Responsibilities
4. Arbitration Process
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

Purpose

The NIAID invites new applications from single institutions, or consortia of institutions, to participate in a network of human immunology profiling research groups. The NIAID is strongly committed to understanding the response of the human immune system to infection and other antigenic challenges, such as those encountered in allergy, transplantation, and autoimmunity. The specific purpose of this FOA is to capitalize on recent advances in immune profiling in order to characterize the diverse states of the human immune system (1) following infection, (2) prior to and following vaccination against an infectious disease, or (3) prior to and following treatment with an immune adjuvant that targets a known innate immune receptor(s). For the purposes of this FOA, immune profiling is defined as a multiparameter assessment of the immune response that can be used to generate a signature or fingerprint reflecting immune status and function. This assessment can be performed using any one (or more) of a variety of methodologies and should take into account the responses of multiple immune cell types. The knowledge gained will lead to improved vaccines and immunotherapeutics for infectious disease and will also provide a foundation for future studies on molecular profiles of human immune-mediated diseases such as allergy, transplant rejection, and autoimmune syndromes.

This initiative seeks immune profiling projects that will rely on the analysis of well-characterized human cohorts and will utilize a variety of modern analytic tools (including, but not limited to systems biology; multiplex transcriptional, cytokine, and proteomic assays; multiparameter phenotyping of leukocyte subsets; and assessment of leukocyte functional status). Each Awardee will establish a research infrastructure to collect, characterize, and store human samples, and will work together with other Awardees to build centralized resources for use by all network investigators, as well as the greater scientific community.

Background

A major challenge in the study of human immunology is to characterize the status of the immune system in diverse populations under both normal (i.e., resting or homeostatic) conditions and in response to antigenic challenge, including longitudinal multiparameter analyses of individuals to obtain highly comprehensive profiles. Recent advances in systems biology, bioinformatics and high-throughput multiplex assays have resulted in unprecedented opportunities to measure immune responses. These approaches have rarely been applied to large cohorts, in contrast to studies of the human genome (e.g., analysis of SNPs, haplotypes, epigenetic markers). Moreover, an objective determination of the resting immune system is a necessary prerequisite to establishing a comprehensive view of human immune responses following antigenic challenge. It should be noted that the concepts of resting and healthy are relative ones with respect to the immune system. A state of immunologic homeostasis does not reflect a lack of immunologic activity, or even necessarily a restful condition. Furthermore, a general state of health does not exclude the presence of sub-clinical disease, or the control of existing disease through treatment. It is not the goal of this initiative to simply describe human immune profiles, but rather to determine how these profiles are perturbed and eventually return to a new homeostatic state after antigenic challenge. Achieving these goals is complicated by the fact that a healthy human population is extremely diverse with respect to age, ethnicity, gender, sub-clinical disease, presence of symptoms, risk and genetic predisposition to disease, medication use, environmental exposures, as well as atopic and nutritional status.

Because vaccines are composed of a variety of immunogens (e.g., live attenuated viruses, viral particles and subunits, bacterial particles and subunits, and pattern recognition receptor ligands), vaccination is a powerful tool to evoke an immune response. This approach provides diverse scientific opportunities via the 1) ability to use known antigens; 2) ability to ascertain the time of (and between) vaccine administration(s); 3) opportunity to study adjuvanted and non-adjuvanted forms of vaccines; 4) ability to compare different routes of administration; 5) access to licensed products in wide clinical use in large cohorts spanning infancy to old age; 6) opportunity to study individuals with underlying medical conditions, impaired host defenses or genetic and environmental predisposition to health problems; and 7) potential for the knowledge gained to be applied to improvements (safety and efficacy) of future vaccines and public health.

Recently, several studies have reported the use of systems biology approaches to characterize the human immune response profile to one of the most successful vaccines ever developed, the yellow fever (YF) vaccine. First developed in the 1930 s, a single dose of the live attenuated YF vaccine can confer protective immunity for more than 30 years in almost all vaccinated individuals. The humoral immune response to YF vaccine is generally considered to be the main mediator of protection against infection with the YF virus. Yet, despite its success, little is known about the mechanisms by which this vaccine induces a highly-effective immune response. Even less is known about which correlates of immune-mediated protection differ between the YF vaccine and the poorly-effective vaccine against tuberculosis and vaccine candidates for malaria and HIV-1. Nevertheless, the YF studies demonstrated that immune system profiles, such as gene expression signatures that appear to correlate with the immunogenicity of the YF vaccine, can be identified in healthy human volunteers. Whether or not these signatures can be used to predict the immunogenicity of vaccines other than the YF vaccine remains to be determined. While the YF vaccine response profiles include genes known to play integral roles in innate or adaptive immunity, these profiles also identified genes that were not expected to be associated with immune responses (e.g., genes encoding proteins that regulate glucose transport and glycolysis). Thus, human immune profiling is likely to reveal novel associations between components of the immune system and other biological systems and processes.

While the lack of correlates of immune protection has been an impediment to vaccine development, predicting the immunogenicity of a new vaccine is only one of several benefits that may arise from the use of new technologies. Recent advances in the field of vaccinology have revealed that vaccine responses are often far more robust than previously appreciated. For example, at peak response times, influenza vaccines transiently elicit unexpectedly high numbers of influenza-specific B cells (about 6% of peripheral blood B cells). Similarly, smallpox vaccines transiently induce unexpectedly high numbers of vaccine-specific CD8+ T cells (about 40% of peripheral blood CD8+ T cells). Clearly, the immunogenicity of a vaccine is not a complete predictor of its efficacy, and it is important to distinguish between response profiles that correlate with vaccine immunogenicity and protection from those that correlate with vaccine toxicity or non-responsiveness. This is especially critical for vaccines that will be used in populations that vary with respect to age, ethnicity, or pre-existing health conditions. One example of such a need comes from the safety profile of live-attenuated vaccinia viruses currently used as vaccines against smallpox. While the major adverse response to this vaccine in healthy normal individuals is an injection site reaction, this vaccine or exposure to vaccinated individuals who are shedding virus can result in a life-threatening disseminated viremia in otherwise healthy people with atopic dermatitis (eczema). Thus, having human immune profiles that predict vaccine safety in different populations is a critical need.

There has been slow progress in developing new formulations and administration regimens for vaccines and immunotherapeutics to treat infectious disease. In particular, there has been limited success in the development of novel adjuvants, defined for the purpose of this FOA as compounds that enhance immune responses by targeting innate immune receptors. To date, only two vaccine adjuvants (alum and MF59) have been approved for use by regulatory authorities. Microarray analysis has recently been used to generate transcriptional signatures in mice injected intramuscularly with alum, MF59, or CpG DNA. A comparison of these signatures revealed that all three adjuvants modulated a common set of 168 genes and promoted antigen-presenting cell recruitment. In spite of these commonalities, MF59 was the stronger inducer of cytokines, cytokine receptors, adhesion molecules involved in leukocyte migration, and antigen-presentation genes. In addition, MF59 triggered a more rapid influx into muscle of CD11b+ blood cells compared with other adjuvants. Furthermore, skeletal muscle was identified as a direct target of MF59. Taken together, MF59 may prove to be the more effective of the three adjuvants because it induces an immunocompetent environment at the injection site by targeting muscle cells. In contrast to desirable activities, adjuvants might also possess toxicities, which may limit their uses. Future efforts to develop less toxic forms will be needed to optimize adjuvant utility. Lastly, it should be noted that a variety of administration routes, as well as numbers and timing of booster immunizations, need to be evaluated as part of vaccine and adjuvant development or post-licensure use. It is likely that immune profiling approaches, along with systems biology and bioinformatics tools, will be capable of rapidly evaluating different formulations and administration regimens in humans.

Research Objectives and Scope

The objective of this FOA is to employ immune profiling approaches to characterize the state of the human immune system (1) after infection, (2) prior to and following challenge with a specific vaccine, or (3) prior to and following treatment with an adjuvant that targets an innate immune receptor(s). An objective determination of the resting immune system is a necessary prerequisite to establishing a comprehensive view of human immune responses following vaccination. It is the goal of this initiative to determine how immune profiles are perturbed and eventually return to a new homeostatic state after antigenic challenge. This effort will rely on the analysis of well-characterized human cohorts and apply a variety of modern analytic tools (including, but not limited to systems biology, multiplex transcriptional, cytokine, and proteomic profiling; multiparameter phenotyping of leukocyte subsets; and assessment of leukocyte functional status). Each Awardee will establish a research infrastructure to collect, characterize and store human samples, and support the complex statistical analysis and informatics needs of the proposed research. Investigators will use new and established comprehensive laboratory and bioinformatic technologies to characterize immune cells and their products obtained from human volunteers within well-characterized cohorts.

An Infrastructure and Opportunities Fund (IOF) will be made available after award to create a shared research infrastructure for ongoing development of the immune profiling network. DF-supported activities may include, for example, the development of shared databases, sample repositories, development of bioinformatics tools, development of sample sparing assays, centralized laboratory resources, and other collaborative activities. The key purpose of the DF is to support shared resources that will be used by all of the Awardees, and ultimately by the greater scientific community, as described by standard NIH data and resource sharing policies. The DF will also support pilot projects and new research opportunities not proposed at the time of the awards.

Applicants may submit either a U01 or a U19 application. A U01 application must contain only one project, although a project should be comprised of several specific aims. Cores are not allowed in U01 applications. U01 applications that contain either an Administrative Core or Scientific Core(s) will be considered non-responsive and will not be reviewed. A U19 application must contain at least two projects organized around a central hypothesis, as well as an Administrative Core and a Pilot Project Core. A U19 application has the option of including one or more Scientific Cores.

Research Projects (U19 and U01 Applications)

All applications are required to use bioinformatic, multiplex, and/or systems biology approaches to establish human immune system profiles using samples from well-characterized cohorts obtained (1) after infection, (2) prior to and following challenge with specific vaccines, or (3) prior to and following treatment with an immune adjuvant that targets a known innate immune receptor(s). Cohorts can be developed with individuals receiving licensed vaccines (e.g., seasonal influenza vaccinations, routine childhood vaccinations, travel clinic vaccinations), or standard clinical care for infections. Cohorts can also be developed with individuals participating in new or ongoing prospective clinical trials that are funded by independent mechanisms. Applicants are encouraged to develop cohorts from independently-funded prospective infection challenge studies in humans. However, applications should not propose any clinical trials and should not propose budgets for any clinical trials. In cases where samples for human immune profiling are to be collected from a new or ongoing prospective clinical trial, applicants can include in their budgets the costs of additional clinical trial-related activities. These include, but are not limited to, the costs of re-consenting study participants, preparation of protocol or IND amendments, as well as sample preparation and shipping. The use of samples and data obtained from clinical trials funded independently from this FOA is allowed and encouraged under this FOA. After award, the Steering Committee may consider requests to use Infrastructure and Opportunities Funds to support small Phase I or II clinical trials (for more information, see Section VI.2.A.3.).

All applications are required to include experimental approaches to measure some aspect(s) of the human transcriptome and/or proteome. An application may include one or more of the following cross-disciplinary research activities:

Applications may NOT request support for:

Applications proposing such studies will be considered non-responsive and will not be reviewed.

Core Projects (U19 applications only)

Administrative Core (required)

An Administrative Core is required for U19 applications. U01 applications that propose an Administrative Core will be considered non-responsive and will not be reviewed Overall, the Administrative Core will support the coordination of efforts across the component projects of a U19, and may support activities to advance the U19’s integration into the consortium. The Administrative Core will be responsible for activities not directly supported by the Awardees research programs. The following conditions apply:

Pilot Project Core (required)

The Pilot Project Core is required for all U19 applications. This Core will support small studies to generate preliminary data for the development of future projects that can be funded from independent sources outside the immune profiling network. The focus of the pilot projects should be limited to the overall research scope and objectives of this FOA, and should, where possible, attract new investigators to the field of human immunology. Each pilot project supported by this Core will be of limited duration (up to two years) and of limited budget (up to $100,000 direct costs/year/project). NOTE that each pilot project will be supported by the Infrastructure and Opportunities Fund, not by individual Awardee funds, and the projects to be funded will be prioritized by the Steering Committee (see below). Therefore, the budget request for the Pilot Project Core should include any necessary administrative costs only, and not the cost for the research itself. After award, the PD(s)/PI(s) of each U19 grant will be required to submit to the Steering Committee a research budget for all projects proposed in the Pilot Project Core. These budgets must be provided in advance of the first meeting of the Steering Committee.

Each Pilot Project Core section of the U19 application must describe three specific pilot projects that will be reviewed by the NIH peer review group. Each of the three proposed pilot projects must focus on one or more of the required or optional topics described in the Research Projects section above. After award, the Steering Committee will prioritize which pilot projects proposed in the individual U19 awards should be supported with Infrastructure and Opportunities Funds in year one.

In addition, applications must include a plan that describes the process by which future requests for pilot projects will be equitably solicited and reviewed within the U19 before being forwarded to the Steering Committee for consideration for Infrastructure and Opportunities Fund support. The application must also include a proposed plan delineating methods for tracking the success of the pilot project program, by following the number of projects that obtain subsequent independent funding and the publications that result from the projects.

Pilot projects may support research by investigators within the U19, as well as by outside investigators. U01 applications should not include proposals for Pilot Projects.

Scientific Core(s) (optional)

One or more Scientific Cores may be proposed in a U19 application. U01 applications that propose a Scientific Core will be considered non-responsive and will not be reviewed. Each Scientific Core must be used by at least two research projects. Scientific Cores should be limited to providing standard assays, reagents, technologies, or other available services to investigators. If during the funding period the use of a Scientific Core is significantly changed through the modification, deletion, or addition of research projects, funds may be re-budgeted within the U19 after approval by the NIAID. Scientific Cores may include clinical, technical (e.g., flow cytometry, multiplex cytokine analysis, biopsy/sample collection), bioinformatics, or other non-administrative activities that directly support the research program. If appropriate to the particular U19, repositories for cells, tissues, reagents, or large data sets may also be proposed as Scientific Core activities. In this case, applications should include methods to obtain, protect, and archive relevant clinical information or family history. In addition, appropriate database capability should be provided to track data and link to other data sets. A plan for the distribution of samples, reagents, data, and other resources should be included and conform to the NIH policies on data and resource sharing (see Section IV.6, Other Submission Requirements and Information).

Applications proposing Scientific Cores must indicate the specific projects to be served by that Core and explain why those Core resources are not otherwise available at the applicant institution or through other grant mechanisms, for example, other NIH-funded Awardees, programs or clinical networks. The apportionment of dollars, or percentage of dollars, that will be required to support each research project should also be presented. U01 applications should not include proposals for Scientific Cores.

Steering Committee

A Steering Committee will be established to direct the overall efforts of the immune profiling network, approve use of the Infrastructure and Opportunities Fund, and evaluate progress and direction of the individual Awardees. All major scientific and budgetary decisions on the use of the Fund will be made by the majority of the voting members of the Steering Committee. In order to maximize utilization of Awardee resources, the NIAID may re-budget individual U01 or U19 funds based on recommendations of the Steering Committee. The Steering Committee will make recommendations for the continuation or re-direction of projects on an ongoing basis and in consultation with the NIAID. Steering Committee responsibilities are described further under Section VI.2.A.3., Cooperative Agreement Terms and Conditions of Award Collaborative Responsibilities.

Infrastructure and Opportunities Fund

An Infrastructure and Opportunities Fund (IOF) will be made available after award to create a shared research infrastructure for ongoing development of the immune profiling network. IOF-supported activities may include, for example, the development of shared databases, sample repositories, development of bioinformatics tools, development of sample sparing assays, centralized laboratory resources, and other collaborative activities. The key purpose of the IOF is to support shared resources that will be used by all of the Awardees, and ultimately by the greater scientific community, as described by standard NIH data and resource sharing policies. The IOF will also support new research opportunities not proposed at the time of the awards. In addition, in the first year, the IOF will support a subset of the pilot projects proposed by U19 Awardees within the original applications. In subsequent years, the IOF may support pilot projects proposed by U01 or U19 Awardees for Steering Committee review and approval post-award.

After all grants have been awarded, one U01 or U19 Awardee institution will be selected by the NIAID to manage the IOF for the entire network. All applicants shall submit budgets that solely reflect the needs of their individual applications and shall not include budgets for funding by the IOF. The IOF is described further under Section VI.2.A.3., Cooperative Agreement Terms and Conditions of Award Collaborative Responsibilities.

Infrastructure and Opportunities Fund Management Plan

All U01 and U19 applications must include an IOF Management Plan. Applications that do not include an IOF management plan will be considered non-responsive and will not be reviewed. The institution chosen by NIAID after award of the U01 and U19 grants to manage the DF must agree to take responsibility for managing the funds, including the disbursement, administration, and reporting on the use of the IOF as approved by the Steering Committee. Management of the IOF will involve:

See Section VIII, Other Information - Required Federal Citations, for laws and policies related to this announcement.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the U01 and U19 cooperative agreement award mechanisms.
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

This initiative is supported by funds provided to the NIH under the American Recovery & Reinvestment Act of 2009 ( Recovery Act or ARRA ), Public Law 111-5. The NIAID has designated $20 million in FY2010 to fund 6-10 new grants and the Infrastructure and Opportunities Fund, contingent upon the submission of a sufficient number of scientifically meritorious applications.

Awards made in response to this FOA will be supported only in the first budget year by Recovery Act funds. Subsequent budget years (two through five) will not use Recovery Act funds.

For U01 applications, budget proposals are limited to $1.5 million total costs in year one and $1.3 million annual total costs in years two through five.

For U19 applications, budget proposals are limited to $4.5 million total costs in year one and $4.0 million annual total costs in years two through five.

NOTE: Recovery Act funds will only support the first budget year of the award, and MUST be completely spent by the end of the first budget year, including spending all Infrastructure and Opportunities Funds allocated to support projects and pilot projects. Award recipients must be prepared to initiate their proposed studies upon issuance of the award. Carryover of unobligated funds from the first to subsequent budget years of the award will NOT be allowed. Any unspent first year funds will be returned. Applicants are encouraged to include in their first year budgets any large, one-time costs to support activities that will be carried out during the project period of the award. Examples of such costs include equipment, large peptide or antibody microarrays, microarray analyses, and small molecule libraries. Alterations and Renovations (A & R) costs will not be allowed.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and Administrative (F & A) costs requested by consortium participants are not included in the direct cost limitations; see NOT-OD-05-004.

This program is supported by funds provided to the NIH under the Recovery Act. The purpose of the Recovery Act is to stimulate the American economy through job preservation and creation, infrastructure investment, energy efficiency and science, and other means. Consistent with these goals, foreign components are not allowed. This cost restriction on foreign components or collaborative sites applies only to the first year of award (ARRA funded segment) under this FOA, but does not apply to the subsequent years. However, foreign institutions/organizations are not eligible to apply to this FOA as the primary applicant.

ARRA requirements will apply to the application submitted and awards made in response to this FOA in their first year. These requirements are described in the NIH HHS ARRA Award Terms. http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply. Consistent with the purposes of the Recovery Act (in particular, to preserve and create jobs and promote economic recovery in the United States, and to provide investments needed to increase economic efficiency by spurring technological advances in science and health), applicants must be a domestic (United States) institution/organization. The United States institution/organization must be located in the 50 states, territories and possessions of the U.S., Commonwealth of Puerto Rico, Trust Territory of the Pacific Islands, or District of Columbia. NIH encourages applications from all interested organization/institutions, including those from Institutional Development Award (IDeA) states and Academic Research Enhancement Award (AREA)-eligible institutions. Foreign organizations/institutions are not permitted as the applicant organization.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution 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 programs.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a team science approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application. Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewal applications are not permitted in response to this FOA.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed in item (box) 2 only of the face page of the application form and the YES box must be checked.

Applicants should follow PHS398 instructions when preparing single project applications (U01). Additional instructions are required for the preparation of multi-project applications (U19) because the PHS Form 398 is designed primarily for individual, free-standing research grant (R01) applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.

Applications with Multiple PDs/PIs

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a 3h for all PD/PIs. NIH requires one PD/PI be designated as the contact PD/PI for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the Contact PD/PI, et. al. The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

SUPPLEMENTAL INSTRUCTIONS FOR THE PREPARATION OF SINGLE-PROJECT U01 APPLICATIONS

The order of presentation should be as follows:

Supplemental Instructions for the Preparation of Multi-Project Applications (U19 applicants only)

The order of presentation should be as follows:

The following section supplements the instructions found in the PHS Form 398 for preparing multi-project grant applications that will be submitted in paper format. Additional instructions are required because the PHS Form 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.

The supplemental instructions below are divided as follows:

A. General Instructions address collaborative efforts among research projects, the administrative and organizational structure, as well as the overall facilities and environment, and the overall budget.

B. Specific Instructions for Individual Projects describe modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

C. Specific Instructions for Core Units describe modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

A. General Instructions

All applications must be submitted on PHS Form 398. The multi-project grant application should be assembled and paginated as one complete document.

1. Form Page 1 - Face Page

Items 1 - 14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.

2. Form Page 2

Using Form Page 2 of the PHS 398, provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major, common theme of the program. Do not exceed the space provided.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the PD(s)/PI(s) of the multi-project application, followed by the Project and Core Leaders of the component research projects and cores, other key personnel, and then other significant contributors.

3. Form Page 3 - Table of Contents

Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.

Bearing in mind that the application will be scientifically reviewed with regard to proposed projects and administrative core, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application as well as to each component research project and the administrative core. A page reference should be included for the budget for each project and the administrative core. Further, each research project should be identified by number (e.g., Project 1), title, and responsible Project Leader, and each Core should be identified by letter (e.g., Core A), title, and responsible Core Leader. The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."

4. Composite Budget

Do not use Form Page 4 of the PHS 398. Instead, using the suggested format presented below, prepare a composite budget for all proposed years of support. Justification for budget elements should not be presented here but in the individual budgets of the projects and cores.

SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support

Component

Year 1

Year 2

Year 3

Year 4

Year 5

All Years

Project 1. Invest.

125,000

130,000

135,200

140,608

146,232

677,040

Project 2. Study

125,000

130,000

135,200

140,608

146,232

677,040

Project 3. Develop.

100,000

104,000

108,160

112,486

116,985

541,631

Core A. Admin. Core.

50,000

52,000

54,080

56,243

58,493

270,816

Core B. DNA

25,000

50,000

52,000

54,080

56,243

237,323

Totals

425,000

466,000

484,640

504,025

524,185

2,403,850

5. Form Page

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry. Detailed budgets are required within the descriptions of each project and core (see below).

6. Biographical Sketch Format Page

Biographical sketches of all professional personnel for all components should be placed at the end of the application with the PD(s)/PI(s) first, followed by those of other key personnel in alphabetical order.

7. Resources Format Page

Do not complete. Essential information is to be presented in the individual research project and core sections of the application.

8. Program Overview (Research Objectives and Strategic Plan; U19 applications only)

This narrative section identifies and describes the overall focus of the proposed Awardee and summarizes the general research plan for this multi-project application. This is an important section wherein the investigative team can provide the concept of the program by stating the general problem area and then defining their strategic plan. This section should include a brief discussion of the central theme, goals, and objectives of the Awardee, the organizational structure of the proposed Awardee, the participating institutions/organizations, and the role of all participating members. As the strategy is laid out, the position of each project and the administrative core in the overall scheme should be clearly presented as well as how the individual projects contribute to the Awardee’s overarching theme or approach. Summarize the special features in the environment and/or resources that make this application strong or unique.

9. Leadership Plan for Multiple PDs/PIs (required, if applicable)

For applications designating multiple PDs/PIs, a new section of the research plan, entitled Multiple PD/PI Leadership Plan must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators, including responsibilities for human subjects and animal studies as appropriate.

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

10. Checklist

One Checklist, placed at the end of the application, is to be submitted for the entire application.

11. Appendix Materials

Refer to Section IV.6. Other Submission Requirements and Information, for instructions on submitting appendix materials.

For each project in the multi-project application, 3 non-publically available publications plus other approved materials are allowed.

B. Specific Instructions for Individual Research Projects

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each research project.

Each individual Research Project must include:

1. Cover Page

The Face Page of the PHS 398 Form should not be used as a cover page for individual research projects within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual research project. This Cover Page will demarcate each individual research project and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page)

Project Number and Title: (e.g., 1. Preclinical Evaluation of HIV Microbicides)

Name of Project Leader: (e.g., Jones, Roberta A.)

Human Subjects: (Yes or No)

If Yes, exemption number:

(or)

Institutional Review Board (IRB) Approval Date: (e.g., 12/13/2006, or "Pending")

(and)

Federal-wide Assurance (FWA) number:

Vertebrate Animals: (Yes or No)

If Yes, IACUC Approval Date: (e.g., 11/17/2006, or Pending)

(and)

Animal welfare assurance number:

Proposed Period of Support:

From: (mm/dd/yyyy - e.g., 07/01/2007)

To: (mm/dd/yyyy - e.g., 06/30/2112)

Costs Requested for Initial Budget Period: (e.g. 07/01/2007-06/30/2008)

Direct Costs: (e.g., $150,000)

Total Costs: (e.g., $162,000)

Costs Requested for the Entire Budget Period: (e.g., 07/01/2007-06/30/2112)

Direct Costs: (e.g., $700,000)

Applicant Organization: (full address)

2. Form Page 2

Provide a Description (abstract) of the research proposed in the project according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the research project will contribute towards attainment of the multi-project program objectives.

List the performance sites where the research will be conducted.

Under "Key Personnel", list the Project Leader, followed by other key project personnel, and then other significant contributors.

3. Form Page 3

Prepare a Table of Contents for the research project using Form Page 3 of the PHS 398.

4. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and justification for the research project using Form Pages 4 and 5 of the PHS 398.

5. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be included at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

6. Resources Format Page

Provide information on resources available for the project.

7. Research Plan (Items 2-5 cannot exceed 25 pages)

Item 2 -- Specific Aims: List in priority order, the broad, long-range objectives and goals of the proposed project. Concisely and realistically describe the hypothesis or hypotheses to be tested. In addition, state the project's relationship to the multi-project program goals and how it relates to other projects or cores. This section is typically one page.

Item 3 -- Background and Significance: Use this section to describe how the proposed research will contribute to meeting the program'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 primary theme of the application.

8. Appendix

All appendix material should be collated as one body of material and submitted on CD.

C. Specific Instructions for Cores

Except for the requirements below, follow the PHS 398 Specific Instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each proposed core.

Each Core must include:

1. Cover Page

The Face Page of the PHS 398 Form should not be used as a cover page for cores within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual core. This Cover Page will demarcate each core and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page:

Core Letter and Core Title: (e.g., A. Administrative Core)

Name of Core Leader: (e.g., Smith, Robert A.)

Human Subjects (Yes or No)

If Yes, Exemption Number

(or)

IRB Approval Date (e.g., 5/14/06, or Pending)

(and)

Federal-wide Assurance (FWA) number

Vertebrate Animals (Yes or No)

If Yes, IACUC Approval Date (e.g., 4/15/07, or Pending)

(and)

Animal welfare assurance number

Proposed Period of Support

From: (mm/dd/yyyy, e.g., 07/01/2007)

To: (mm/dd/yyyy, e.g., 06/30/2012)

Costs Requested for Initial Budget Period

Direct Costs: (e.g., $50,000)

Total Costs: (e.g., $70,000)

Costs Requested for the Entire Budget Period

Direct Costs: (e.g., $212,323)

Total Costs: (e.g., $297,252)

Applicant Organization (full address)

2. Form Page 2

Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the multi-project program objectives.

List the performance sites where the core activities and services will be conducted.

Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors.

3. Form Page 3

Prepare a Table of Contents for the core using Form Page 3 of the PHS 398.

4. Budget Pages (PHS 398 Form Pages 4 and 5)

Prepare a detailed budget and justification for the core using Form Pages 4 and 5 of the PHS 398

5. Biographical Sketches

Do not repeat the biographical sketches of participating investigators since this information will be located at the end of the overall application (and therefore will be referenced in the Overall Table of Contents).

6. Resources Format Page

Provide information on resources available for the core.

7. Core Research Plan

Note: Items 2-5 cannot exceed 10 pages for the Administrative Core and each Scientific Core, and cannot exceed 15 pages for the Pilot Project Core

8. Appendix

All appendix materials should be collated as one body of material and submitted on CD.

3. Submission Dates and Times

Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): September 15, 2009
Application Receipt Dates(s): October 15, 2009
Peer Review Date(s): February, 2010
Council Review Date(s): May, 2010
Earliest Anticipated Start Date: June, 2010

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Quirijn Vos, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3137, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Tel: (301) 451-2666
Fax: 301 480 2408
E-mail: qvos@niaid.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Quirijn Vos, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3137, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Tel: (301) 451-2666
Fax: 301 480 2408
E-mail: qvos@niaid.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and for responsiveness by the reviewing Institute. Incomplete and/or non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Information on the status of an application should be checked by the Principal Investigator in the eRA Commons at: https://commons.era.nih.gov/commons/.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project (see NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements and Information

Human Subjects Information

The following material should be included with the application as part of the human subjects section:

Where samples for human immune profiling are to be collected from a new or ongoing prospective clinical trial, a synopsis of the clinical trial protocol must be provided along with final informed consent form(s) for the parent trial. To the extent permitted by applicable laws and regulations, NIH will treat as confidential trial information that the trial sponsor deems proprietary. Copies of informed consent form(s) for the proposed studies and any independently-funded, parent clinical trial that will supply samples, if different, must be included. It is recommended that applications submitted under this FOA have clear language in the informed consent form(s) that distinguishes proposed immune profiling studies from the clinical trials with which they are linked. It is also recommended that the following items be clarified in the consent form: (1) additional blood or tissue that will be collected as part of the proposed profiling study(ies); (2) the right of the subjects to refuse to participate in the proposed profiling study(ies) and still participate in the parent clinical trial; and (3) that no charges to the subject for participation in the proposed profiling study(ies) is(are) incurred. Any incentives provided to subjects to participate in the proposed profiling study(ies), if in addition to those under the parent clinical trial, should be clearly described and strongly justified.

In the human subjects section, the applicant should also provide a memorandum of understanding signed by the applicant, an appropriate representative of the applicant institution, the principal investigator of the parent clinical trial and his or her academic institution, an appropriate representative of the sponsor of the parent clinical trial and holder of the IND, if applicable and not one of the above. This memorandum will confirm agreement among the various parties and will outline their expectations of the agreement in the following areas: 1) ownership, analysis, access, and release of data from the proposed immune profiling studies; 2) access to the data from the parent clinical trial (how/when) that is needed to analyze the data generated by the proposed profiling studies, including procedures for prevention of unblinding of the parent trial; 3) documentation of quality assurance procedures for both the parent clinical trial and the proposed profiling studies, and documentation of Data and Safety Monitoring procedures for the parent clinical trial, especially for efficacy trials; 4) intellectual property management; and 5) publication of the proposed profiling study results.

When clinical studies or trials are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study (http://www3.niaid.nih.gov/research/resources/toolkit/standards.htm) . An updated NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

Applicants are encouraged to contact NIAID program staff well in advance of the application submission date to discuss the proposed research program and its responsiveness to this FOA.

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Research Plan Page Limitations

See Section IV.2, Content and Form of Application Submission for research plan page limitations.

Appendix Materials

All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the application. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html.

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

No supplemental/update information will be accepted.

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value of, and advance research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in Resource Sharing section of the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms and related resources, or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or

weight) or the presence or absence of a disease or condition. For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability. As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Review Criteria for U01 Applications and for Individual Research Project Components of U19 Applications:

Overall Impact. 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 five core review criteria, and additional review criteria (as applicable for the project proposed).

Core Review Criteria. Reviewers will consider each of the five review criteria below in the determination of scientific and technical 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? What is the likelihood that the results of the study will be translated into important new knowledge on human immune status and responses to infection, vaccination, or adjuvants?

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

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

Approach. Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Is there a major focus on human immune profiling using bioinformatic, multiplex, and systems biology approaches in the context of infection, vaccination, or adjuvant function/toxicity? Are the human cohorts to be analyzed well characterized, available in sufficient numbers, and appropriate for the stated goals? If animal studies are proposed, are they appropriate models to inform human immune status or responses? Will they serve to validate the funding of human studies? Is there evidence of ability to perform the proposed studies? Are adequate resources available to conduct the proposed studies, including a database and sample repository as well as statistical and bioinformatics capability?

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?

In addition to the above review criteria for individual research projects, the criteria below will be applied to U19 applications only and will be considered in the determination of their overall scientific merit and impact/priority score.

Review Criteria for Administrative, Pilot Project, and Scientific Cores

Review Criteria for the Overall U19 Application

A single numerical overall impact/priority score will be assigned to the whole application after consideration of all the elements. The overall score for the application will be based primarily on the scientific merit of the individual components, with additional consideration of the overall synergy and integration of all the components, the overall program organization, and the capabilities of the associated personnel. The overall score will depend on the perceived ability of the proposed work to advance development of an immune profiling program. The clarity and completeness of the application’s combined components with regard to specific goals, proposed feasibility, and progress towards stated goals are critical. As such, the following items will be considered in the determination of the overall scientific and technical merit and impact on the priority score for the entire application:

Additional Review Criteria. As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, 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.

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.

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.

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.

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

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

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 (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm);

2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and

3) Genome-Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

Infrastructure and Opportunities Fund Management Plan. Reviewers will consider whether this plan describes an adequate administrative structure, adequate procedures to support the Steering Committee, satisfactory reporting procedures, and sufficient institutional commitment for administration of the Infrastructure and Opportunities Fund.

The following will be considered in making funding decisions:

Appeals will not be permitted. See NOT-OD-09-054, Recovery Act of 2009: NIH Review Criteria, Scoring System, and Suspension of Appeals Process.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General. In addition, as part of just-in-time information for Recovery Act awards, for any modular budget application, a detailed budget will be required prior to award.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official.

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard NIH terms of award, all awards will be subject to the HHS Standard Terms and Conditions for Recovery Act awards in Year 1. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

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. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm) and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS 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 consortium 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.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for: defining the details and goals of the project as a whole within the guidelines of this FOA; overseeing/performing the scientific activities; and administratively managing the U01 or U19 grant. One PD/PI from each U01 and U19 award will be a voting member of the Steering Committee (see below), will participate in all Steering Committee activities, and will follow the policies and procedures developed by the Steering Committee. Awardees agree to accept close coordination, cooperation, and participation of the NIAID staff in those aspects of the scientific and technical management of the project described below.

Monitoring Clinical Studies

NIAID policy requires that clinical studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. An updated NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy including terms and conditions of award is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

Infrastructure and Opportunities Fund Management

After all grants have been awarded, one U01 or U19 awardee institution will be selected by the NIAID to manage the Infrastructure and Opportunities Fund (IOF) for the entire network. This institution must agree to take responsibility for managing the funds, including the disbursement, administration, and reporting on the use of such funds as approved by the Steering Committee. Management of the IOF will involve:

Intellectual Property

The awardee is solely responsible for the timely acquisition of all appropriate propriety rights, including intellectual property rights, and all materials needed for the awardee to perform the project.

Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any propriety rights, including intellectual property rights, or any materials needed by the awardee to perform the project.

The awardee is required to report to the U.S. Government all inventions made in the performance of the project, as specified by 35 U.S.C. Sect. 202 (Bayh-Dole Act).

Awardees are expected to make new information and materials known to the research community in a timely manner through publications, web announcements, and reports to the NIAID, or other mechanisms.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2.A.2. NIH Responsibilities

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

After award of the grants, the NIAID will establish an External Advisory Board (EAB) to advise the NIAID by reviewing, evaluating, and prioritizing the scientific progress of the individual awardees and the network. Applicants should not contact any individuals for the purpose of serving on this EAB, nor should they identify any such individuals in their applications.

Although applicants can propose scientific advisory boards (SABs) to advise the PD(s)/PI(s) of the individual awards, applicants should not contact any individuals for the purpose of serving on these Scientific Advisory Boards, nor should they identify any such individuals in their applications.

Additionally, 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.

2.A.3. Collaborative Responsibilities

Steering Committee

A Steering Committee will be established to serve as the governing board of the network. The Steering Committee will direct the collaborative work of the awardees, determine the use of the Infrastructure and Opportunities Fund, evaluate the progress and direction of the individual awardees and network, and make recommendations for the continuation or re-direction of projects on an ongoing basis and in consultation with the NIAID. In order to maximize the utilization of awardee resources, the Steering Committee may re-budget individual awardee funds, with the approval of the NIAID. One PD/PI from each U01 and U19 award will serve as a voting member of the Steering Committee. The two NIAID project scientists will also serve as voting members of the Steering Committee. U19 Project Leaders and other relevant investigators may serve as non-voting members, as determined by the Steering Committee. NIAID may also appoint additional staff to serve on the Steering Committee as non-voting members. A Steering Committee Chair will be elected by majority vote from among the non-Government Steering Committee voting members. Selection of the Chair will be repeated yearly, by majority vote of the non-Government voting members.

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

The Steering Committee will meet face-to-face during the Annual Scientific Meetings and at least one additional time per year. The Steering Committee will also meet monthly by teleconference in the first year of award, and in subsequent years will meet by teleconference at intervals to be decided by the Steering Committee and the NIAID.

All major scientific and budgetary decisions on the use of the Infrastructure and Opportunities Fund (IOF) will be determined by majority vote of the Steering Committee voting members. To permit comprehensive data reporting, uniformity of practices, assay standardization and validation, sample sharing, and priority setting by the entire Steering Committee, the formation of subcommittees or working groups, and the delegation to them of discrete responsibilities and authorities, will be strongly encouraged. The formation of a clinical research subcommittee, a publications subcommittee, a bioinformatics subcommittee, as well as an assay standardization and validation subcommittee will be required.

As network-supported research projects mature, it may be appropriate to consider small Phase I or II clinical trials to be supported by the IOF Fund. The focus of the clinical trials should be limited to the overall research scope and objectives of this FOA. Network researchers may propose such trials to the Steering Committee. If the concept is approved by the Steering Committee and NIAID, and is feasible under the fiscal constraints of the IOF, appropriate activities may be initiated within the Steering Committee or a subcommittee to plan, conduct, and monitor such studies in compliance with the NIAID Clinical Terms of Award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf). A similar approach was undertaken within the NIAID RCE (Regional Centers of Excellence in Biodefense) program and will serve as a model for the human immunology profiling network. No clinical trials will be initiated or conducted without the full participation and approval of NIAID and completion of all required documentation outlined in the NIAID Clinical Terms of Award and other federal regulations, guidance and NIH policy governing the conduct of clinical trials. The network External Advisory Board may also advise at the planning, implementation, and reporting stages of any clinical trials. All clinical trials funded through the IOF will be conducted using existing NIAID or NIH clinical trial infrastructure, such as protocol review and approval by the DAIT Clinical Research Committee, input from the DAIT Regulatory Group, use of facilities funded by the National Center for Research Resources Clinical and Translational Science Awards, or other facilities already established and maintained by NIH or a network-sponsoring institution, and approved by NIAID. Network resources will not be used to develop or support clinical research infrastructure. Any proposed studies may not exceed the clinical and scientific resources of an applicant’s institution(s) and must not exceed the funding period of the network.

NOTE: Phase III and IV clinical trials will NOT be supported by the IOF.

The responsibilities of the Steering Committee will include the following activities:

Annual Scientific Meetings

All Awardees will participate together in an initial meeting, arranged by the NIAID Project Scientists, to be held soon after award in the Bethesda, Maryland area; and will participate in face-to-face Scientific Meetings of all PDs/PIs to be held annually thereafter. The Scientific Meetings are open to members of the network and to NIH extramural staff. These meetings will serve as opportunities for members to provide the latest update on their research, exchange ideas and information, and discuss collaborations among consortium members. Meeting participants will identify the group’s tangible resources, capabilities, and needs to advance overall program goals. The PDs/PIs are required to give oral presentations at the annual meetings on current and planned activities and projects.

Data Coordination and Management

As recommended by the Steering Committee, each awardee will be responsible for providing NIAID with data on the management, quality control, and analysis of clinical trials/studies, using procedures and standards determined by the Steering Committee. Specific analysis may be performed by the NIAID as directed by the Steering Committee or its designee. The awardees will retain custody of and have primary rights to all data developed under these awards, subject to Government rights of access consistent with HHS and NIH policies.

The Steering Committee will determine how data from multiple Awardees collaborating on a study will be analyzed.

2.A.4. Dispute Resolution

A Dispute Resolution Panel composed of three members will be convened to resolve any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH. The three members of the panel will include: a designee of the Steering 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 rights to appeal an adverse action that is otherwise appealable in accordance with 42 CFR Part 50, Subpart D and 45 CFR Part 16.

3. Reporting

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Act, as well as applicable OMB guidance regarding the use of Recovery Act funds. As noted above, grantees must also comply with the HHS Standard Terms and Conditions for Recovery Act awards. The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

The PD(s)/PI(s) of each U01 and U19 award will be responsible for organizing an annual report on their activities and major findings, to be presented at the Annual Scientific Meeting. The lead investigator on any studies linked to clinical trials supported by the Infrastructure and Opportunities Fund will be responsible for providing quarterly status reports to the NIAID as well as an annual report to the Steering Committee.

The PD/PI of the award that is chosen to manage the Infrastructure and Opportunities Fund will be responsible for organizing an annual report on the disbursement of all Fund money and the status of both expended and unobligated funds.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Dr. Matthew J. Fenton
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3105, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-8973
FAX: (301) 402-0175
Email: fentonm@niaid.nih.gov

Dr. Helen R. Quill
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3013, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 435-4416
FAX: (301) 480-2381
Email: hquill@niaid.nih.gov

2. Peer Review Contacts:

Quirijn Vos, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3137, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Tel: (301) 451-2666
Fax: 301 480 2408
E-mail: qvos@niaid.nih.gov

3. Financial or Grants Management Contacts:

Sahar Rais-Danai
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2261, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 594-7460
Fax: 301-493-0597
Email: raisdanais@niaid.nih.gov

Section VIII. Other Information

Required Federal Citations

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Act and Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR Part 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants ( NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight), or the presence or absence of a disease or condition. All applications, regardless of the amount requested, proposing a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh-Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for Federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov/). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This FOA is supported by funds provided to the NIH under the Recovery Act, Pub. L. No. 111-5.

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under Sections 301 and 405 of the PHS Act, as amended (42 USC 241 and 284) and under 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs (LRP):
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.

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