Part I Overview Information

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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: B Cell Immunology Partnership Program For HIV-1 Vaccine Discovery (U19)

Announcement Type
New

Request for Applications (RFA) Number: RFA-AI-09-022

Catalog of Federal Domestic Assistance Number(s)
93.855, 93.856

Key Dates
Release Date: June 16, 2009
Letters of Intent Receipt Date:November 4, 2009
Application Receipt Date: December 4, 2009
Peer Review Date: April 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/qa/revniaid.htm
Expiration Date: December 5, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

• Purpose. This Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, (NIH) solicits grant applications from institutions/organizations that propose multidisciplinary research to define the basic immune mechanisms by which a broadly cross-reactive neutralizing antibody response can be elicited in uninfected individuals to protect against infection by a broad range of HIV-1 strains. Specifically, this FOA will support innovative studies to identify new HIV-1 envelope immunogens and immunization strategies for induction of broadly cross-reactive neutralizing antibody, and basic B cell immunology research designed to increase fundamental knowledge of the immunological mechanisms involved in the induction and regulation of immune responses leading to an HIV-1 broadly cross-reactive neutralizing antibody response. Preliminary data are required, and expertise in basic immunology and the HIV-1 virus should be evident. This multi-project cooperative agreement grant program will support a partnership to communicate ideas and progress among recipients of U19 awards as well as recipients of previous U01 awards issued under B Cell Immunology for Protective HIV-1 Vaccines (RFA AI-07-014). Clinical trials will not be supported by this FOA.
• Mechanism of Support. This FOA will utilize the U19 cooperative agreement mechanism. This FOA extends Division support provided by two previous FOAs of similar scientific scope: RFA-AI-07-014 that utilizes the U01 mechanism and RFA-AI-07-015 that utilizes the R21 mechanism.
• Funds Available and Anticipated Number of Awards. It is anticipated that $3 million annual total costs will be available for this FOA and that 2-3 new awards will be made. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
• Budget and Project Period. The total project period for an application submitted in response to this FOA may not exceed five years. Direct costs are limited to $1 million in any single year.
• Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
• Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their 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 support.
• Number of PDs/PIs. More than one PD/PI, or multiple PDs/PIs, may be designated on the application.
• 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.
• Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
• Application Materials. See Section IV.1 for application materials.
• Hearing Impaired. Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936

Table of Contents

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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

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

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Section I. Funding Opportunity Description

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1. Research Objectives

The B Cell Immunology Partnership Program for HIV-1 Vaccine Discovery is designed to assist researchers in supporting the multi-disciplinary scientific expertise and resources needed to facilitate fundamental research that will inform HIV vaccine discovery and immunization strategies for eliciting broadly cross-reactive HIV-1 antibodies. The concept of partnership is invoked to convey the nature of the activity: to coordinate information sharing and resources among U19 award recipients and recipients of previous NIAID grant awards of similar scientific scope issued under RFAs AI-07-014 and AI-07-015, which utilize the U01 and R21 mechanisms, respectively.

Background

It is generally accepted that an effective HIV-1 vaccine will require the coordinate induction of both CD8+ cytotoxic T cells and highly potent broadly cross-reactive virus-neutralizing antibodies for protection at mucosal surfaces. In addition, the high level of antigenic variability of HIV-1 will require that such immune responses be sufficiently cross-reactive to afford protection against a large number of viral strains. Although highly potent type specific neutralizing antibodies are elicited during natural infection and exert immune pressure driving sequential escape variants, there is little evidence that these antibodies impact early virus replication or influence control of chronic infection.

HIV infection only rarely induces the types of antibodies needed for protection against heterologous infection, thus there is the need to identify novel forms of HIV envelope proteins and mechanisms to induce B-cell responses yielding broadly cross-reactive neutralizing antibodies. Targeting the conserved regions of the HIV-1 envelope for antibody responses has proven to be extremely difficult, as a number of mechanisms combine to make these regions either non-immunogenic or poorly accessible to antibodies. Despite the many mechanisms by which HIV-1 can preclude or evade antibody responses to conserved domains, and despite its extraordinary capacity to generate mutant variants that retain pathogenicity, the identification of a small group of monoclonal antibodies that have broadly cross-reactive neutralizing activity suggest that a vaccine that elicits these antibodies is attainable. These broadly cross-reactive neutralizing antibodies were derived from human sources and were shown to neutralize diverse primary isolates of HIV-1 in vitro. Several individual monoclonal antibodies were also shown to protect against virus challenge in nonhuman primate model systems when administered singly or in combination.

Although highly potent type specific neutralizing antibody is elicited during natural infection and has been shown to exert immune pressure by driving sequential escape mutations in the virus, there is little evidence describing a role of neutralizing antibody in control of virus replication during infection. These studies highlight our limited understanding of neutralizing epitopes on the HIV-1 envelope and the mechanisms involved in neutralization and underscore the need to define additional neutralizing targets and to understand fundamental immune mechanisms involved in the generation of broadly cross-reactive neutralizing antibodies. Despite diverse empirical and iterative structure-function based approaches toward developing HIV-1 env immunogens, expression vehicles, and delivery strategies, the development of a preventive vaccine that elicits a broadly cross-reactive neutralizing antibody response continues to elude us. It will be necessary to combine current structure based env immunogen design with novel immunization and delivery strategies that are capable of optimizing the affinity and maturation of the anti-HIV-1 B cell response to vaccination. Thus, while advances continue to be made, there remains a need for the identification of new viral targets, novel immunogen design and delivery systems, better understanding of mechanisms involved in the B-cell response to HIV-1 envelope immunogens, and immunization strategies to elicit effective anti-viral antibody responses. Solving the neutralizing antibody problem is a major goal of NIH and identifying mechanisms of viral neutralization and approaches that induce broadly cross-reactive neutralizing antibody is a priority of the Global HIV/AIDS Vaccine Enterprise (GHAVE) (http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020025).

Research Objectives and Scope

The objectives of the B Cell Immunology Partnership Program for HIV-1 Vaccine Discovery are to support: (1) innovative studies to identify new HIV-1 envelope immunogens and immunization strategies for induction of broadly cross-reactive neutralizing antibody, and (2) studies designed to increase fundamental knowledge of the immunological mechanisms involved in the induction and regulation of immune responses leading to an HIV-1 specific broadly cross-reactive neutralizing antibody response. Applicants are expected to have an identified strategy, based on solid scientific rationale and supported by preliminary data. All proposed research Programs should focus on approaches aimed at understanding B cell responses involved in induction of HIV-1 specific broadly cross-reactive neutralizing antibodies. Broadly cross-reactive neutralizing antibodies are defined for the purpose of this FOA as those with the ability to block multiple, diverse primary isolates of HIV-1 from infecting cells, such that the antibodies prevent or substantially limit infection in vitro or in vivo.

The following are examples of research areas that may be addressed in response to this FOA:

• Design of HIV-1 envelope immunogens and delivery vehicles or vectors for targeting and adjuvanting antibody responses
• Biophysical studies characterizing HIV-1 envelope immunogen structure and antibody-antigen interaction including NMR and crystallography studies
• Identification of new neutralization targets and mechanisms of anti-HIV-1 neutralization
• Methodology for identifying and cloning new anti-HIV-1 after vaccination
• Studies examining mechanisms for generating high affinity broadly neutralizing antibodies against HIV-1
• Studies examining the relative roles of different B cell subsets responding to HIV-1 envelope immunogens in determining the quality of immune response and the emergence of immunodominance patterns
• Exploiting the role of innate immune mechanisms, B cell receptor/Toll-like receptor synergies, opsonizing antibody, and immunomodulatory molecules in shaping B cell responses and memory to HIV-1 antigens
• Relationship between generation of antigen-specific B cell memory and plasma cell differentiation in response to HIV-1 envelope immunogens
• Induction and maintenance of B cell lineages in different anatomical niches following vaccination with HIV-1 envelope immunogens
• Induction of T-dependent and T-independent IgG and IgA responses at mucosal surfaces and formation of mucosal memory specific for HIV-1 immunogens
• Studies examining the induction of follicular T helper cells (Tfh) and their interaction with B cells resulting in the generation of broadly neutralizing antibodies to HIV-1 envelope immunogens
• Studies examining determinant specificity and the quality of CD4+T cell help in influencing antibody specificities to HIV-1 immunogens
• Fundamental studies examining relative and global gene expression, including epigenetic changes, associated with B-cell differentiation. Studies employing multiparametric analysis (e.g. specificity, isotype, affinity) for profiling primary antibody responses to HIV -1 env immunogens. Studies examining the potential immune suppressive effects of HIV-1 envelope immunogens in eliciting T cell help and the role of inducible Tregs in regulating antibody responses
• Proposed limited B cell work in the SIV infection model may be supported only if the work is well justified and directly relevant to mechanisms involved in B cell responses to HIV-1.

The inclusion of human and/or macaque B cell studies or humanized mouse models is strongly encouraged.

Studies on human tissues may be included and samples obtained from independently-funded clinical trials may be used in the proposed work. Applicants should describe how such studies will help to identify and characterize the underlying immune mechanisms and contribute to the goals outlined in this solicitation. Methods to address all regulatory requirements and the protection of human subjects must be described in the application.

A list of projects supported under previous B cell related issuances can be found at (http://www.niaid.nih.gov/ncn/newsletters/2008/0702-bcell.htm). This site contains examples of research concepts supported jointly by the NIAID Division of AIDS (DAIDS) and Division of Allergy Immunology and Transplantation (DAIT).

NOTE: This FOA will not support:

• Clinical trials;
• Research in support of HIV-1 vaccine product development. The reader is referred to the following websites that contain examples of concepts that historically have been supported and are currently supported by other mechanisms (http://www3.niaid.nih.gov/topics/HIVAIDS/Research/vaccines/funding/default.htm, http://www.iavi.org/Pages/home.aspx ;
• Purely descriptive basic research or structural studies not addressing a clear hypothesis involving antibody-focused immunological approaches relevant to development of a successful HIV-1 vaccine;
• Induction of T cell responses to HIV-1 that are unrelated to broadly neutralizing antibody production and B cell activation; mapping of HIV-1 T cell epitopes; pathogenesis studies; correlates of immunity; epidemiology; therapeutics discovery or development; and HIV-1 protein structural studies unrelated to production of broadly reactive neutralizing antibody;
• Studies that propose vector construction, vector improvement, or new vaccine vectors;
• Basic B cell immunology studies that propose work with non-HIV-1 epitopes; and
• Basic B cell immunology studies that propose non-unique use of unmodified or previously identified HIV-1 neutralizing epitopes or non-protective epitopes.

Applications proposing studies in the excluded areas will be considered non-responsive applications and will not be reviewed.

Program Partnerships

The interdisciplinary nature of the research to be funded under this FOA will require close collaboration between scientists of at least two major disciplines: B cell immunologists conducting fundamental basic research, and HIV vaccine experts. These two groups have not been traditionally linked and thus, the development of strong ties among recipients of the B cell Immunology Partnership Program for HIV-1 Vaccine Discovery awards (U19), and recipients of B Cell Immunology for Protective HIV-1 Vaccines grant awards in response to RFA-AI-07-014 (U01) and RFA-AI-07-015 (R21), and NIAID Program staff through a Program Partnership is expected to result in the formation of a new, closely collaborating community of scientists with the same interest and focus that may be able to impact the field beyond the gains achieved by the individual groups. As a Program Partnership, this FOA encourages mutually beneficial communication among the funded Programs to discuss research progress and ideas, facilitate the sharing of protocols, reagents and knowledge between Scientific Programs, and place the effort of the partnership within the context of the rest of the HIV vaccine field. An annual B cell Immunology Partnership Program for HIV-1 Vaccine Discovery workshop to discuss research highlights and advances made during the preceding year and to establish priorities for future research is essential for evolving collaborations and building a network among investigators and NIH program staff that will facilitate discovery based research.

Scientific Projects

Each application must be composed of a minimum of two interrelated research projects. At least one research project must be aimed toward understanding B-cell maturation and differentiation and mechanisms involved in the induction of antibody responses and memory formation as it relates to responses to HIV-1.

Scientific Cores

One or more scientific cores may be proposed. A scientific core is a resource within a multi-project grant that must support at least two of the proposed research projects. The application must indicate the specific projects to be served by the scientific core(s). Examples of services that could be provided by such cores include: routine in vitro assays including neutralizing antibody assays, dedicated FACs and microarray analysis resources, cell processing and monoclonal antibody production, sample archiving.

Administrative Core

Each application must include an Administrative Core headed by the PD/PI. The application must describe overall management, coordination, and supervision of the program.

Additionally, each applicant should include in the Administrative Core a separate Administrative Partnership Plan and budget to cover the costs of an annual B cell Immunology Partnership Program for HIV-1 Vaccine Discovery Workshop that will be organized and may be hosted on a rotating basis by U19 awardees of this solicitation. One of the main objectives of the Administrative Partnership Plan is to plan and organize this annual workshop for the HIV and B cell community to present and discuss current advances and challenges in eliciting HIV-1 and/or SIV neutralizing antibody responses. Participants in the annual workshop may also include NIH grantees currently funded by the B-Cell Immunology for Protective HIV-1 Vaccines awards (i.e., grantees funded through our previous B cell RFAs (AI-07-014 and AI-07-015), HIV researchers from the NIAID Vaccine Research Center (VRC), and other invited speakers. The intent of this workshop is to promote communications and collaborations within and across the NIH B cell-HIV community. Significant program involvement in organizing an annual workshop among partners is anticipated and will facilitate this effort. In addition to describing the logistics of sponsoring an annual workshop, the Administrative Partnership Plan should propose an organizational plan to facilitate inter-communications between individually funded Programs, and NIH Program Officials and Project Scientists to exchange data, resources and technologies to accelerate discovery. This may be achieved through scheduled conference calls, emails, or WIKI sites or other technologies.

External Scientific Advisory Panel

The PD/PI may propose an External Scientific Advisory Panel (ESAP). Applicants should not contact or identify potential individuals who might be invited to serve on the advisory panel.  Applicants should describe the expertise required for individuals to serve on the advisory board but should NOT name them in the application.  The ESAP members will attend an annual Program review meeting coordinated by the PD/PI and which will include the PD/PI and representatives from each Program Project and Program Cores awarded under this Program, and will also include the NIH Program Official and/or Project Scientist. The ESAP will review program accomplishments, activities, and the contribution and interrelationship of individual Program Projects to the overall goals of the Program. The ESAP will provide a written report of the meeting to the PD/PI and NIH Program Officials intended to evaluate the current years progress and to make recommendations on priorities for the next year of funding. The ESAP also attends the internal annual meeting for each U19 award. This meeting is distinct from the annual workshop organized through the Administrative Partnership Plan. The role of the ESAP is exclusively for internal Program review and members of the ESAP are not required to participate in the annual workshop organized under the Administrative Partnership Plan. The budget for the SAP should be included as part of the Administrative Core budget.

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

Section II. Award Information

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1. Mechanism of Support

This funding opportunity will use the NIH multi-project Cooperative Agreement (U19) grant award mechanism(s). 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".

At this time, NIAID has not determined whether and how this solicitation will be continued beyond the present FOA.

2. Funds Available

NIAID intends to commit $3 million in FY 2009 to fund 2-3 new awards in response to this FOA. An applicant may request a project period of up to 5 years under this FOA, and a budget for direct costs up to $1 million per year.

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 NIAID 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 costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

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

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1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Small Businesses
• For-Profit Organizations (Other than Small Businesses)
• State Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribally Designated Organizations
• County Governments
• City or Township Governments
• Special District Governments
• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• U.S. Territory or Possession
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Organizations)
• Other(s):
  • Eligible Agencies of the Federal Government
  • Faith-based or Community-based Organizations.

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 support.

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. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. 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.

Multiple PDs/PIs may be designated on the U19 application; however, only one Project Leader (PL) or Core Leader (CL) may be designated for each project or core, respectively for multi-project U19 applications.

A PD/PI a multi-PI application, may serve as a collaborator for another multi-project application provided there is no scientific overlap with the application submitted by the PD/PI. An investigator may only be a PD/PI on one application.

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 Application. Applicants may submit more than one application, but the applications must clearly be 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

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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 Grants Info, Telephone (301) 710-0267, Email: [email protected].

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.

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

• Request budgets in U.S. dollars.
• Contain detailed budgets. See NOT-OD-06-096.

In addition, for applications from foreign organizations:

• Charge back of customs and import fees is not allowed.
• Every effort should be made to comply with the format specifications, which are based upon a standard U.S. paper size of 8.5 x 11 within each PDF.
• Funds for up to 8% Facilities and Administrative (F&A) costs (excluding equipment) may be requested. See NOT-OD-01-028, March 29, 2001.                        
• Organizations must comply with Federal/NIH policies on human subjects, animals, and biohazards.
• Organizations must comply with Federal/NIH biosafety and biosecurity regulations. See Section VI.2., Administrative and National Policy Requirements

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS

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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application. However, only one PL or CL may be designated for each project or core for multi-project U19 applications.

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: November 4, 2009
Application Receipt Date: December 4, 2009
Peer Review Date: April 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July, 2010

3.A.1. Letter of Intent

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

• Descriptive title of proposed research
• Name, address, and telephone number of the Principal Investigator
• Names of other key personnel
• Participating institutions
• Number and title of this funding opportunity

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:

Priti Mehrotra, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Phone: 301-435-9369
Fax:      301-480-2408
Email:   [email protected]

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:

Priti Mehrotra, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Phone: 301-435-9369
Fax:      301-480-2408
Email:   [email protected]

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 or renewal award if such costs: are necessary to conduct the project, and 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 or renewal 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

Supplemental Instructions for the Preparation of Multi-Project Applications

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 Cores must provide services or resources to support at least two research projects. Instructions 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.

When multiple PDs/PIs are proposed, use the Face Page-Continued page to provide items 3a-3h for all PDs/PIs.  The Contact PI should be listed on block 3 of Form Page 1-Face Page, with additional PDs/PIs listed on the Face Page-Continued.

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/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 5

Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry.

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/PI(s) first, followed by those of other key personnel in alphabetical order.

7.  Other Support Format Page

Do not complete. (Any required information will be requested from successful applicants prior to grant award.)

8.  Resources Format Page

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

9.  Program Overview (Research Objectives and Strategic Plan)

This narrative section summarizes the overall research plan for the multi-project application and is limited to 25 pages. The multi-project application should be viewed as a confederation of interrelated research projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section for it provides the group of investigators an opportunity to give conceptual wholeness to the overall program by giving a statement of the general problem area and by laying out a broad strategy for attacking the problems. As the strategy develops, each project and core should be cited briefly as to its place in the overall scheme. Summarize the special features in the environment and/or resources that make this application strong or unique.

10. 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.

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.

11. Checklist

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

12. Resource Sharing Plan

One Resource Sharing Plan, placed at the end of the application, is to be submitted for the entire application.

B. Specific Instructions for Individual Research Projects

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)
IRB Approval Date: (e.g., 12/13/2006,or "Pending")
(and)
Federalwide 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: (mmddyyyy - e.g., 07/01/2007)
To: (mmddyyyy - 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: $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 Principal Investigator of the multi-project application, followed by the Project Leaders of the component research projects and cores, other key 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. 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).

5.  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.
• Item 4 -- Preliminary studies
• Item 5 Research design and methods

6.     Appendix. Do not create an appendix for an individual project.

7.    Resource Sharing Plan. Do not create a resource sharing plan for an individual project.

For all other items in the individual research project application, follow the usual PHS 398 instructions.

C.  Specific Instructions for Cores

Administrative Core. Each application must include an Administrative Core headed by the PD/PI and must describe the overall management, coordination and supervision of the program.  Provide an administrative plan discussing the structure and roles of administrative staff, including the training and experience of proposed staff and the functions they will perform; how fiscal and other resources will be prioritized, allocated and managed; how communications will be facilitated; and how research-related travel and training will be budgeted. Funding for the overall administrative efforts, including secretarial, and/or other administrative services, expenses for publications demonstrating collaborative efforts, communication expenses, etc., should be requested here.  Additionally, each applicant should include in the Administrative Core a separate

Administrative Partnership Plan and budget to cover the costs of developing and maintaining a communications network and sponsoring an annual B Cell Immunology Partnership Program workshop for HIV-1 Vaccine Discovery, which will be organized and may be hosted on a rotating basis by the awardees of this RFA. The Administrative Partnership Plan should describe mechanisms to facilitate communication between the individual cooperative agreements funded under this announcement, and NIH NIAID staff responsible for the program in order to exchange data, resources and technologies to accelerate discovery. This may be achieved through scheduled conference calls, email, or WIKI sites or other technologies

Scientific Cores. A scientific core is a resource to the multi-project grant as a whole and must support at least two of the proposed research projects. The application must indicate the specific projects to be served by the Scientific Core(s).  This section of the application should present a clear picture of the facilities, techniques, and skills that the core will provide and describe the role of the Scientific Core Leader and each of the key participants.  The apportionment of dollars or percentage of dollars that will be required to support each component research project which will utilize each scientific core should also be presented.

All Cores

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. Monoclonal Antibody Production 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., 5/14/2006, or Pending)
(and)
Federal Wide Assurance (FWA) number

Vertebrate Animals (Yes or No)
If Yes, IACUC Approval Date (e.g., 4/15/2007, or Pending)
(and) Animal welfare assurance number

Proposed Period of Support
From: (mmddyyyy, e.g., 07/01/2007)
To: (mmddyyyy, e.g., 06/30/2012)

Costs Requested for Initial Budget Period
(e.g., Direct Costs: $50,000)
(e.g., Total Costs: $70,000)

Costs Requested for the Entire Budget Period
(e.g., Direct Costs: $212,323)
(e.g., Total Costs: $297,252)

Applicant Organization
(full address)

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 research will be conducted.

Under "Key Personnel", list the Principal Investigator of the multi-project application, followed by the Project Leaders of the component research projects and cores, other key personnel, and then other significant contributors.

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

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).

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

• Item 2 - Specific Aims: List in priority order, the broad, long-range objectives of the proposed core. In addition, state the core's relationship to the multi-project program goals and how it relates to the research projects or other cores in the application.
• Item 3 - Background and Significance: Use this section to describe how the proposed core activities will contribute to meeting the program’s goals and objectives and explain the rationale for the selection of the general methods and approaches proposed to accomplish the specific aims. In addition, this section should indicate the relevance of the core to the primary theme of the multi-project application.

Appendix. Do not create an appendix for a core.

Resource Sharing Plan. Do not create a resource sharing plan for a core.

For all other items in the individual core application, follow the usual PHS 398 instructions

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

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.

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: Investigators seeking $500,000 or more in direct costs in any year 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/.

Specific Instructions for Foreign Applications

All foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

Section V. Application Review Information

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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 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:

• Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned a priority score.
• Receive a written critique.
• Receive a second level of review by the National Advisory Allergy and Infectious Diseases Council.

The following will be considered in making funding decisions:

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

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. 

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?

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? Does the investigative team bring complementary and integrated expertise to the project? Does the research team comprise and benefit from generally recognized experts in B cell immunology and HIV who are considered to be uniquely qualified to address the goals of this FOA?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the project address an innovative hypothesis or critical barrier to progress in developing a preventive HIV-1 vaccine? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

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

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

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

Additional Review Criteria for Multi-Project (U19) Applications Only

Review Criteria for Cores

Administrative Core

Reviewers will consider each of the criteria below in the determination of scientific and technical merit. Is the administrative and organizational structure appropriate to the central focus of the overall program and sound to facilitate attainment of the objective(s) of the proposed program? Are plans for management and accountability of funds and communication within the overall program appropriate? Are the plans for coordination, problem identification and resolution, and the establishment of a strong collaborative environment for the program appropriate? Is the experience, level of commitment, and availability of the Administrative Core Leader and administrative staff adequate to manage the overall program? Are plans to organize an annual workshop for the HIV and B cell community to present and discuss current advances and challenges in eliciting HIV-1 antibody responses adequate? Is internal quality control of on-going research and management of day-to-day program activities sufficient? Are plans for communication and cooperation among program leaders and/or program investigators including plans for management of contractual agreements, resolution of disputes and allocation of funds adequate?

Scientific Cores (if applicable)

Reviewers will consider each of the criteria below in the determination of scientific and technical merit. Are the justification and usefulness of the core services and resources to the individual Research Projects appropriate, sound, and support at least two research projects? Is the relationship of each core to the central focus of the overall program strong and justified? Are the quality of the relevant facilities or services provided (including procedures, techniques, quality control) and criteria for prioritization and usage acceptable, appropriate, and used effectively? Are the qualifications, competence, and commitment of the Core Leader and key personnel appropriate?

Review Criteria for Evaluating the Overall Application

Overall score: a single numerical priority score will be assigned to the whole application after consideration of all of 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 following items will be considered in the determination of the overall scientific and technical merit and priority score for the entire application in addition to the standard review criteria: Is the program as a whole scientifically meritorious? Do the individual research projects and cores together relate to the common theme, showing cohesiveness, multidisciplinary interactions, coordination, and synergy? Are the overall program goals significant and focused on studies that increase knowledge in the field? Does the PD/PI possess the leadership skills and scientific ability to develop a program of integrated research projects with a well-defined central research focus? Have the PD/PI and other Project/Core Leaders planned to devote adequate time and effort to the program and commit adequate time onsite? Does the PD/PI demonstrate a strong management approach in terms of staffing, organization, communication, leadership, lines of authority, as well as the ability to manage subcontracts and consultants? Are the proposed timelines for the initiation and completion of proposed studies appropriate and feasible?

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 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).

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

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).

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

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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.

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 NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for: defining the research plan and goals; overseeing/performing the scientific activities of the plan; monitoring the accomplishment of successful completion of milestones within the timeframe and budget proposed; cooperating with NIAID programmatic, technical and administrative staff; and administratively managing the U19.

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. However, awardees must be committed to making research samples and tools, methods, data and materials that they develop under this program available to other U19 members of this program as well as the research community.

If clinical studies 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. 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.

All clinical research activities performed under this award must be in compliance with all U.S. Federal regulations, guidance and NIH policies applying to the conduct of research involving human subjects and regulatory applications for new drug or biological licenses when applicable. These include, but are not limited to: U.S. Code of Federal Regulations (CFR) Title 21, Parts 11, 50, 54, 56, 312, 314, 601 and Title 45, Part 46; ICH guidance for Good Clinical Practice (GCP); and NIH grants policy (refer to http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). In addition, the awardee must assure that all sites in the U.S. and outside the U.S. comply with the following:

a. Each institution engaged in human subjects research has a current, approved Assurance Number on file with the DHHS Office for Human Research Protections (OHRP).

b. Each protocol and informed consent document is approved by the responsible Institutional Review Board (IRB)/Ethics Committee (EC) prior to subject entry.

c. For Investigational New Drug (IND) studies, each local Investigator of Record has supplied a completed FDA Form 1572 to NIAID for each protocol conducted at each site.

d. Each study investigator and sub-investigator has provided current curriculum vitae to NIAID.

e. Each study participant (or legal representative) will sign an IRB/EC-approved protocol consent prior to entry on study as part of the Informed Consent Process.

All clinical research activities performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for protection of human subjects.

2. A.2. NIH Responsibilities

NIAID Program staff will have substantial involvement that is above and beyond the normal stewardship role in awards, as described below.

Program staff will monitor progress of each award by participating in conference calls and meetings, will keep the awardees updated on progress from other NIAID-supported initiatives, will offer linkages to the investigators with other researchers funded by NIAID, and will help facilitate the accomplishment of stated research objectives. Program staff will also participate in meetings and the annual reviews organized by the grantees, but will not have any decision-making authority or voting rights regarding the execution of the research. Program staff will also participate in inter-program conference calls and will facilitate access to resources through the AIDS Reagent Repository or contract sources within the Division of AIDS and other NIAID resources.

The NIAID Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Official will monitor program progress, approve changes, have access to data generated under these awards and may periodically review the data and progress reports. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study. The Program Officer will be named in the award notice and may also serve as the NIH Project Scientist.

The NIAID Project Scientist will review the performance of each awardee through consideration of annual reports and site visits. The Project Scientist will provide advice and guidance on technical issues, such as reviewing progress or approving changes in proposed milestones. Administrative assistance will be provided by the NIAID Project Scientist.

The NIAID Division of AIDS will serve as a liaison between pharmaceutical companies, the Food and Drug Administration (FDA) and program investigators if and when regulatory guidance or review is required. In accordance with NIH policy, all clinical studies performed through this program must be conducted in accordance with applicable Federal regulations.

2.A.3. Collaborative Responsibilities

Scientific Meetings

Each awardee will participate in scientific meetings to be held annually. All Principal Investigators are required to attend these meetings, together with additional scientific staff from their grants when appropriate. All travel costs for U19 personnel to attend the Scientific Meetings will be borne by the Principal Investigators and must be included in the proposed budget. The annual scientific meeting is open to members of this program and NIH extramural staff, and is a forum for members to provide the latest update on their research, exchange ideas and information, and discuss collaborations among program members. Meeting participants will identify the group’s tangible resources, capabilities and needs to advance overall program goals. The Principal Investigators are required to make oral presentations on current and planned activities and projects.

2.A.4. Arbitration Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: 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 arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 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.

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.

Section VII. Agency Contacts

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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:

Jeffrey Ahlers, PhD
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 5138, MSC-5138
6700-B Rockledge Drive
Bethesda, MD 20892-5138
Telephone: 301-594-2518
FAX: 301-402-3684
Email: [email protected]

Jorge Flores, M.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 5140, MSC-7628
6700-B Rockledge Drive
Bethesda, MD 20892-7628
Phone: 301-435-3758
FAX: 301-402-3684
Email: [email protected]

2. Peer Review Contacts:

Priti Mehrotra, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3138, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Phone: 301-435-9369
Fax:      301-480-2408
Email:   [email protected]

3. Financial or Grants Management Contacts:

Howard England
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2229, MSC-7614
6700B Rockledge Drive
Bethesda, Maryland 20892-7614
Voice Mail/Phone: 301-594-9875
FAX: 301-493-0597
Email: [email protected]

Section VIII. Other Information

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Required Federal Citations

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 Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) 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 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 http://grants.nih.gov/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, 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 new PHS Form 398; 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 Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award. 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 (DHHS) 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 DHHS 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) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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 FOA 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 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 the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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 NIH Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

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:
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.