Part I Overview Information


Department of Health and Human Services

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

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

Title: Reagent Development for Toll-like and Other Innate Immune Receptors (U24)

Announcement Type 
New

Request For Applications (RFA) Number: RFA-AI-08-021

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

Key Dates
Release Date: March 21, 2008
Letters of Intent Receipt Date: June 23, 2008
Application Receipt Date: July 22, 2008
Peer Review Date: November 2008
Council Review Date: January 2009
Earliest Anticipated Start Date: April 1, 2009  
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/ 
Expiration Date: July 23, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), invites new applications from institutions with multidisciplinary research teams to participate in the development of new reagents for Toll-like and other innate immune pattern recognition receptors (PRRs). The goal of this FOA is to support the development and wide distribution of reagents to the scientific community for use as research tools to study the expression and physiological functions of PRRs in humans and animal model systems. Examples of reagents to be created and characterized include antibodies, soluble receptors, fusion proteins, RNA-based inhibitors, and small molecules. Awardees will form an interactive Steering Committee to share information, expertise, and resources leading to the rapid development of novel research tools. In addition, an External Advisory Group will be formed by the NIAID after award to provide critical advice on reagent prioritization and changes in experimental methods or directions. The overall goal of this program is to facilitate the development of new vaccines, therapeutics, and diagnostics for the prevention and treatment of existing, emerging, and re-emerging infectious diseases. 

Background

The innate immune system comprises a broad array of cells and mediators that initiate host responses to potentially harmful infectious organisms and help direct the adaptive immune system to generate long-lived pathogen-specific T and B cell responses and immune memory. Innate immune pattern recognition receptors (PRRs) detect invariant molecular topographies that are found in microorganisms but not in mammals, or are found in cellular compartments not usually occupied by the mammalian counterpart. PRRs are targets of adjuvant components of successful vaccines, and they provide non-specific stimuli that synergize with pathogen-specific antigen responses to promote long-lasting adaptive immunity.  In addition, activation through PRRs alone may stimulate protective, but transient, nonspecific immune responses to mitigate acute infections. The immunopathology associated with certain infections is likely to be caused by excessive activation of PRR-induced signaling pathways, and greater understanding of these responses is needed to aid the development of novel therapeutics to prevent or reverse tissue damage. Finally, more detailed information on PRR-induced innate immune mechanisms may lead to improved diagnostic tools for assessing the type, stage, or severity of an infection, and may help to define immune correlates of protection to evaluate new vaccine adjuvant candidates.

Although much information has been obtained from basic research in this area over the past decade, much still remains to be learned about individual innate immune PRRs and their pathways of action; about the interactions and integrated responses induced by engagement of multiple PRRs over the course of infection or vaccination; and about the interplay between innate and adaptive immune responses. In part, progress is impeded by the lack of reliable reagents to study many of the innate immune components. In particular, both structural and biochemical studies are needed to advance understanding of PRRs, but experimental set-backs have slowed progress. For example, difficulties in protein expression for some of the PRRs, and the lack of specific ligands or antibodies for their detection, has hindered progress in defining their functional importance.

An expert panel workshop (http://www3.niaid.nih.gov/about/organization/dait/conferences.htm) on the development of reagents for Toll-like and other innate immune receptors was sponsored by the NIAID in June 2007. Recommendations from that panel include a practical and focused investment in the creation of reagents needed by the scientific community to advance the analysis of innate immune activation and regulation in the context of infectious disease. This new program will support reagent development for mammalian PRRs and will promote synergistic interactions among the awardees to facilitate the generation and characterization of new reagents for the research community.

Research Scope

Multidisciplinary research teams will be supported to develop novel reagents to study PRRs of the mammalian innate immune system. Applicants are encouraged to include experts in immunology, chemistry, biophysics, or other areas as required by the research topic. Applications may be submitted from single institutions or consortia of institutions. Studies on human PRRs are especially encouraged, although a focus on animal model systems is also permitted if sufficiently justified. Any type of reagent(s) may be proposed for development if it is a PRR or is focused on reactivity with a PRR. Applications should include well-justified approaches based on a compelling need for the reagent and be supported by strong preliminary data and documented technical capability.

Research areas of interest include, but are not limited to:

The following research areas are excluded from this FOA:

Applications that include research in excluded areas will be considered non-responsive to this FOA and will not be reviewed.

Steering Committee

Project Directors/Principal Investigators (PDs/PIs) funded under this program will form a Steering Committee after award, to foster collaborations among the awardees, to facilitate access to resources from other NIAID programs, and to provide advice on research direction, experimental problems encountered during the funding period, and methods for distribution of reagents to the scientific community. After award, a PRR Reagent Development website will be established by the NIAID with input from the Steering Committee members to facilitate communications and data and resource sharing within the group. Awardees will confer by teleconference on a quarterly schedule and will participate in an annual face-to-face meeting to discuss results and research plans.

External Advisory Group

After award, the NIAID will establish a PRR Reagent Development External Advisory Group of scientists to provide expert advice to the Steering Committee and the NIAID on reagent prioritization issues, novel technical approaches, and technical feasibility issues during the funding period. Based on expert advice from the External Advisory Group and the Steering Committee, the NIAID may approve changes in research direction for individual projects. Such changes will be considered for the purpose of developing the highest priority reagents by the most efficient methods.

Sharing Research Resources

All awardees will be required to share the reagents developed under this program with the general scientific research community. Separate from and in addition to the Resource Sharing Plan(s) described in Section IV.6., which do not factor into determining the priority score for the application, applicants must propose a Sharing Novel Reagents Plan for sharing new reagents.

Because of the highly focused and practical nature of this FOA, certain aspects of the PHS 398 Research Plan should be especially well developed:

Background and Significance

The choice of PRR target(s) proposed for reagent development must be well justified in the context of: a compelling need for the reagent within the research community; the importance of the targeted PRR pathway to innate immune response and regulation; the potential impact of its use in research on infectious diseases; and its ultimate potential impact on human health.

Research Design and Methods

The technical approaches proposed to generate and validate a new reagent(s) should be supported by strong preliminary data and described in sufficient detail to allow ready evaluation of: the appropriateness of the approach; the technical advantages and limitations of the approach; the availability of and expertise in alternative approaches; and the overall feasibility of generating a useful reagent that can be distributed to and used by the broader scientific research community. Proposed animal models or in vitro human cell/tissue systems should be justified within the rationale for choice of experimental systems. Potential pitfalls, interpretations of expected results, and alternative interpretations and experimental approaches should also be provided.

Investigators

Applicants are strongly encouraged to include investigators with documented expertise and clearly defined roles for each scientific discipline required for reagent generation and characterization. Expertise may be incorporated through the use of collaboration, consortium, or subcontract agreements established before submission of the application and fully described within the application.

Sharing Novel Reagents Plan

Separate from and in addition to the Resource Sharing Plan(s) described in Section IV.6, a Sharing Novel Reagents Plan must be included, which details a description of the methods by which a validated reagent developed under this program will be provided to the research community in a timely manner. The Plan description is limited to five pages and should be included in the application as a separate unit at the end of the Research Plan, Item 5 (Research Design and Methods). Entitle this part of Item 5 as “Sharing Novel Reagents Plan.” It does not count against the 25 page limit for Research Plan, Items 2-5 . Budgetary items to cover anticipated costs for transfer of new reagents to appropriate repositories, etc., should be included in the regular Budget and Budget Justification Sections of the application.

The following suggestions may assist applicants in developing the reagent sharing plan:

Because widespread dissemination of different types of reagents may require different approaches for distribution, there is no standard plan for this activity. Applicants should consult the NIH Grants Policy Statement for additional guidance.

FOR THIS FOA, THE SHARING NOVEL REAGENTS PLAN WILL BE CONSIDERED AND COMMENTED ON BY THE PEER REVIEW GROUP, BUT WILL NOT BE USED IN DETERMINING SCIENTIFIC MERIT AND PRIORITY SCORE.   AFTER AWARD, THE PLAN MAY BE RE-NEGOTIATED WITH THE NIH PROGRAM OFFICIAL.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the U24 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 the “Just-in-Time” information concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).

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

2. Funds Available

The estimated amount of funds available for support of 4-5 projects awarded as a result of this announcement is $2 Million for fiscal year 2009. Future year amounts will depend on annual appropriations.

An applicant may request a project period of up to five years and a budget for direct costs not to exceed $350,000 per year unless prior written approval is obtained from the Scientific Contact listed in Section VII.

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

Facilities and administrative 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 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.

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

Applicants are not permitted to submit a resubmission application in response to this FOA.

Renewal applications are not permitted in response to this FOA.

Applicants may submit more than one application, provided each application is scientifically distinct in both the PRR(s) targeted and the experimental approach(es) proposed. Thus, even if focused on a different reagent, the scientific approach must also be substantially different in a second application. For example, it is NOT acceptable to use the same approaches to create reagents to two different Toll-like Receptors (TLR) in two separate applications, if the applicant is only changing the name of the TLR and other incidental parameters within each application.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed on lines 1 and 2 of the face page of the application form and the YES box must be checked.
 
Annual Scientific Meetings

Travel costs to attend an Annual Scientific Meeting of all awardees must be included in the budget request. Assume that the Annual Scientific Meeting will require two days and take place in the Bethesda, Maryland area. Travel costs for the PD/PI and up to five additional key personnel should be requested for each annual meeting. 

In addition, Annual Meetings of the Steering Committee will take place in conjunction with the Annual Scientific Meetings. Awardees must agree to the “Cooperative Agreement Terms and Conditions of Award” described in Section VI.2.A “Award Administration Information” regarding  mandatory participation in the Steering Committee.

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/archive/grants/policy/nihgps_2003/index.htm#_Toc54600260.

In addition, for applications from foreign organizations:

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.

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.

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: June 23, 2008
Application Receipt Date: July 22, 2008
Peer Review Date: November 2008
Council Review Date: January 2009
Earliest Anticipated Start Date: April 1, 2009

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Katrin Eichelberg, Ph.D.   
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3128, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Phone: 301-496-0818
Fax: 301-480-2408
Email:  keichelberg@niaid.nih.gov

3.B. Sending an Application to the NIH

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

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

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

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

Katrin Eichelberg, Ph.D.   
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3128, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Phone: 301-496-0818
Fax: 301-480-2408
Email:  keichelberg@niaid.nih.gov

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

6. Other Submission Requirements and Information

Appendix Materials

All paper PHS 398 applications submitted for May 25, 2008 and subsequent due dates must provide appendix material on CD only, and include five identical CDs in the same package with the application.  Paper applications submitted for due dates prior to May 25, 2008 may voluntarily provide the appendix on five identical CDs; if submitting CDs it is not necessary to include a paper appendix. (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: Regardless of the amount requested, investigators are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

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

(c) Genome-Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  A genome-wide association study is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

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


1. Criteria

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

2. Review and Selection Process

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

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

The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a meritorious priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Is the choice of PRR target(s) well justified? Will the new reagent(s) be of broad benefit to the scientific community to advance research on infectious diseases?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the studies on the use of animal model systems well justified, if proposed? For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs? Does the proposed Sharing Novel Reagents Plan adequately describe the methods by which newly developed reagents will be made available to the research community? Is the proposed reagent(s) likely to be sufficiently stable and functional with properties appropriate for use by other members of the research community? Is the timeline proposed for distribution of the reagent appropriate? Is the proposed means of distribution appropriate?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Is there a compelling need in the research community for the reagent(s) to be developed?

Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the PD/PI(s) and other researchers? Do the PD/PI(s) and the investigative team bring complementary and integrated expertise to the project (if applicable)? Does the application include all the expertise needed for reagent development and characterization? Is the PD/PI(s) highly committed to the principles of open sharing of research resources? For applications designating multiple PDs/PIs, does the Leadership Plan ensure that there will be sufficient coordination and communication among the PDs/PIs? Are the administrative plans for the management of the projects appropriate, including plans for resolving conflicts?  

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the rating:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan section on Human Subjects in the PHS 398 instructions).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five points described in the Vertebrate Animals section of the Research Plan will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Whether the project presents 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 will be assessed.

2.C. Resource Sharing Plan(s)

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise in the FOA. Program staff within the IC will be responsible for monitoring the resource sharing.

Review Considerations

Reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or priority score. Program staff will be responsible for overseeing the data sharing policy and for assessing the appropriateness and adequacy of the proposed data-sharing plan.

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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/archive/grants/policy/nihgps_2003/index.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/archive/grants/policy/nihgps_2003/index.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 research plan; cooperating with NIAID programmatic, technical, and administrative staff; and administratively managing the U24 grant. Each PD/PI will be a voting member of the Steering Committee, will participate in all Steering Committee activities, and will follow the policies and procedures developed by the Steering Committee. The PD/PI must agree to accept the close cooperation and participation of the PRR Reagent Development External Advisory Group and the Steering Committee in the relevant aspects of scientific and technical management of the project. The PD/PI must also be committed to making the reagents developed under this program available to the broader research community, subject to the rights described below.

Monitoring Clinical Studies

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

Intellectual Property

The successful development of reagents for innate immune receptors will aid the advancement and improvement of novel therapeutic interventions, adjuvants, and diagnostics to regulate and enhance innate and acquired immune responses to infection. The NIAID recognizes that intellectual property rights are likely to play an important role in achieving the goals of this program. To this end, all awardees understand and acknowledge the following:

Awardees are encouraged to reach early consensus with any proposed partners regarding intellectual property and other legal matters that may arise during the project. In addition, awardees are expected to exercise their Bayh-Dole rights in a manner that does not conflict with the goals of this award or the intent of the Bayh-Dole act to promote the utilization, commercialization, and availability of U.S. Government-funded inventions for public benefit. Awardees are expected to make new reagents known to the research community in a timely manner through publications, web announcements, and reports to the NIAID, or other mechanisms; and to make the reagents available through existing publicly accessible repositories or other appropriate channels.

Highly Pathogenic Agents and/or Select Agents or Toxins (Agents)

The research proposed in this grant may involve Select Agents and/or Highly Pathogenic Agents.

NIAID defines a Highly Pathogenic Agent as an infectious Agent or Toxin that, under some circumstances, may warrant a biocontainment safety level of BSL3 or higher according to any one of the following sources:

If there is ambiguity in the BMBL guidelines and/or there is disagreement among the BMBL, an institutional committee or institutional official, the highest recommended containment level must be used.

At the beginning of each Progress Report clearly indicate:

Whether or not any research with a Highly Pathogenic Agent or Select Agent has been performed or is planned to be performed under this grant.

If yes, describe if your IBC or equivalent body or official has determined, for example, by conducting a risk assessment, that the work being planned or performed under this grant may be conducted at a biocontainment safety level that is lower than BSL3.

If the work involves Select Agents and/or Highly Pathogenic Agents.  Also address the following points:

Any changes in the use of the Agent(s) or Toxin(s) that have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable, as determined by your IBC or equivalent body or official.

If work with a new or additional Agent(s)/Toxin(s) is proposed in the upcoming project period, provide:

For domestic work with Select Agents provide documentation of Registration status of all domestic organizations/entities where Select Agent(s) will be used.

Please be advised that changes in the use of a Select Agent not previously described in the original application or last progress report will likely be considered a change in scope and, therefore, require NIH awarding office prior approval.

Publications

The PD/PI will be responsible for the timely submission of all abstracts, manuscripts, and reviews (co)authored by members of the grant and supported in part or in total under this Agreement. Publications or oral presentations of work performed under this Agreement are the responsibility of the PD/PI and will require appropriate acknowledgement of NIAID support. Timely publication of major findings is encouraged.

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

2.A.2. NIH Responsibilities

An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

A program official from the NIAID Division of Allergy, Immunology, and Transplantation (DAIT) will serve as the NIH Project Scientist for this program, facilitating but not directing activities. In conjunction with other NIAID scientific program staff, the Steering Committee, and the External Advisory Group, the NIH Project Scientist will: assist awardees in refining and implementing the Sharing Novel Reagents Plan after award; provide advice and guidance on technical issues; participate in the design of activities recommended by the Steering Committee or External Advisory Group; advise in the selection of sources or resources (e.g., determining where a particular reagent may be found); or advise in management or technical performance. The NIH Project Scientist will help to maintain the overall scientific balance on the program commensurate with emerging research opportunities, and will participate as a non-voting member of the Steering Committee. The NIH Project Scientist will also: serve as the administrative liaison to the External Advisory Group; attend meetings of the External Advisory Group; help coordinate program activities through the Steering Committee; assist in promoting and encouraging the sharing of unique research resources developed under this program; and lead the development of the NIAID website on PRR Reagents. The NIH Project Scientist will schedule the meetings of the Steering Committee and the External Advisory Group.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

Steering Committee

PDs/PIs funded under this program will form a Steering Committee after award to:

Each PD/PI will be a voting member of the Steering Committee. A Steering Committee Chair will be elected by majority vote from among the U24 PDs/PIs at the first Steering Committee meeting. A website will be established by the NIAID with input from the Steering Committee members to facilitate communications and data and resource sharing within the group. Awardees will confer by teleconference on a quarterly schedule and will participate in an annual face-to-face meeting in the Bethesda, MD area to discuss results and research plans, as well as recommendations obtained from the External Advisory Group. The annual Steering Committee meetings will be held in conjunction with the Annual Scientific Meetings (see below). Each full member will have one vote. In order for a decision or course of action to be recommended by the Steering Committee, a majority of the possible votes must be cast in favor of the decision or course of action. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

NIAID intends to support the peer-reviewed studies proposed in the awarded grant applications. However, under special circumstances, the Steering Committee will establish guidelines and review procedures to evaluate and determine opportunities for redirection or modification of the peer-reviewed projects. Such recommendations may be initiated by advice from the External Advisory Group, from an individual PD/PI, or from NIAID staff. All recommended changes must be reviewed and approved by the NIAID program official prior to implementation and redirection of funds.

External Advisory Group

After award, the NIAID will establish an External Advisory Group comprised of three to five investigators that are not affiliated with this U24 program. The External Advisory Group will meet periodically with the PDs/PIs and with the NIH Project Scientist and other NIAID program staff to evaluate progress and provide advice on future directions. The External Advisory Group will meet in person at least once each year and will provide scientific evaluations of progress and help ensure that the needs of the broader scientific community are being met. The External Advisory Group will also consult on the incorporation of emerging technologies into specific research projects. Members will be selected for their broad expertise in relevant areas of research, and additional members may be added during the funding period as dictated by the needs of the program. Members of the External Advisory Group may attend certain Steering Committee meetings. Periodically, at intervals determined by the NIH Project Scientist, a formal request for advice on specific subjects may be submitted to the External Advisory Group for written response.

Annual Scientific Meetings

All awardees will participate together in an initial scientific meeting, arranged by the NIH Project Scientist, to be held soon after award in the Bethesda, Maryland area; and will also participate in face-to-face scientific meetings of all PDs/PIs to be held annually thereafter. All PDs/PIs are required to attend these meetings, and may include additional staff from their grants when appropriate. The scientific meetings are open to members of this U24 program and to NIH extramural staff, and will provide opportunities for members to report recent results, exchange new ideas and information, and establish collaborations. Members of the External Advisory Group may be included at these meetings as determined by the Steering Committee.

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


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:

Helen Quill, Ph.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3013, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601

Telephone: (301) 496-7551
FAX: (301) 480-2381
Email: hquill@niaid.nih.gov 

2. Peer Review Contacts:

Katrin Eichelberg, Ph.D.   
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3128, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616 (U.S. Postal Service or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Phone: 301-496-0818
Fax: 301-480-2408
Email:  keichelberg@niaid.nih.gov

3. Financial or Grants Management Contacts:

Victoria Connors
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2122, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-5065
Fax: (301) 480-3780
Email: connorsv@niaid.nih.gov

Section VIII. Other Information


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 public 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/archive/archive/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. Applications that do not provide this information will be returned without review.

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 or Health Systems Agency review. 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.


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