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 Disease (NIAID), (www.niaid.nih.gov)
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (www.niddk.nih.gov)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), (www.niams.nih.gov)
Office of Research on Women's Health (ORWH), Office of the Director, (http://orwh.od.nih.gov/)
National Institute of Neurological Disorders and Stroke (NINDS), (http://ninds.nih.gov)

Title:  Autoimmunity Centers of Excellence (U19)  

Announcement Type
This is a reissue of RFA-AI-02-006, which was previously released May 13, 2002.

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

Request For Applications (RFA) Number: RFA-AI-08-010

Catalog of Federal Domestic Assistance Number(s)
93.855, 93.846, 93.847, 93.853, 93.121

Key Dates
Release Date: April 11, 2008
Letters of Intent Receipt Date: June 16, 2008 - (New Date July 1, 2008 per NOT-AI-08-047)
Application Receipt Date: July 15, 2008 - (New Date August 1, 2008 per NOT-AI-08-047)
Peer Review Date: November, 2008
Council Review Date: January, 2009
Earliest Anticipated Start Date: April, 2009
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/budget/qa/  
Expiration Date: July 16, 2008 - (New Date August 2, 2008 per NOT-AI-08-047)

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), the National Institute of Neurological Disorders and Stroke (NINDS), and the Office of Research on Women's Health (ORWH) invite applications for the Autoimmunity Centers of Excellence (ACE) program.  This cooperative research program seeks to:

Background    

Autoimmune diseases result from an immune response directed against the body's own tissues.  The most common autoimmune diseases include systemic lupus erythematosus, multiple sclerosis, type 1 diabetes mellitus, and rheumatoid arthritis.  Autoimmune responses can affect many organs, resulting in a wide variety of diseases, including autoimmune myositis, thyroid disease, hepatitis, hemolytic anemia, inflammatory bowel disease, pemphigus, alopecia, and many others.  Although many individual autoimmune diseases are rare, autoimmune diseases as a group afflict millions of Americans. Women are disproportionately affected. The costs of these diseases are enormous, including hospitalizations, outpatient visits, lost productivity, and reduced quality of life for patients and their families. 

Clinically divergent autoimmune diseases are likely to have common as well as unique immune aspects. For example, self-reactive T and B lymphocytes probably initiate, exacerbate, or modulate different diseases. The number, activity, and specificity of these cells are determined by many different molecules, cells, and processes. These include: the frequency and affinity of specific antigen receptors on lymphocytes; the binding of antigen to the molecules of the major histocompatibility complex (MHC, HLA in humans) and presentation by different cell types; the presence of co-stimulatory molecules; the activity of regulatory T cells; the concentration of extracellular mediators including cytokines and chemokines; and the relative strengths of intracellular signaling pathways leading to activation, anergy, or apoptosis (programmed cell death). Strategies to modify the immune response at any of these steps could prevent or reduce autoimmune disease. Agents that block co-stimulatory signals or cytokines, interrupt or alter binding of antigen to MHC molecules, or modulate the appearance and activity of regulatory cells have been evaluated for treatment of multiple autoimmune diseases.  Approaches currently under evaluation target molecules in many pathways, including CD3, CD11a (LFA-1), CD19, CD20, CD22, CD25 (IL-2Ra), CD40 ligand (CD154), CD52 IgE, Fc Receptors (including CD23), and CTLA-4.  The mechanisms of therapeutic action of treatments proven to be effective, such as transient ablation of mature B cells with anti-CD20 (Rituximab), remain unclear and would likely be highly informative if better understood. 

Understanding how current and new therapies work can guide development of the next generation of more effective and targeted therapies.  Mechanisms of action are best defined by basic studies performed in parallel with clinical testing of immune interventions.  Currently, autoimmune diseases are treated by multiple clinical specialists because the affected organ systems vary and overlap. Thus, multiple sclerosis is treated by neurologists; type 1 diabetes, Graves' disease, and Hashimoto's thyroiditis by endocrinologists; systemic lupus erythematosus, rheumatoid arthritis, and scleroderma by rheumatologists; pemphigus by dermatologists; and inflammatory bowel disease by gastroenterologists.  A cooperative group of scientists who are able to evaluate new therapeutic agents in several autoimmune diseases offers many advantages.  By working together in planning, performance, and evaluation of clinical trials/studies, clinical specialists, clinical scientists, and basic scientists can accelerate the evaluation of new therapies and improve our understanding of their underlying mechanisms of action.

Research Objectives and Scope

The major goal of this program is to support an integrated basic and clinical research program focused on tolerance induction and immune modulation to prevent or treat autoimmune disease.  Basic researchers and clinicians, working together, can accelerate the translation of advances from the laboratory to the clinic and better utilize patient materials for testing mechanisms of action.  NIAID, NIDDK, NIAMS, NINDS, and ORWH seek multidisciplinary centers with scientists who have new ideas, take novel approaches, and use state of the art technology to improve our understanding of the basic mechanisms of autoimmunity and self tolerance and the translation of that knowledge to design and evaluate clinical interventions to prevent or treat autoimmune diseases. The Clinical Components of the Autoimmunity Centers of Excellence will perform early clinical trials, typically phase I and phase II, and mechanistic studies, hereafter designated clinical trials/mechanistic studies, in patients with autoimmune disease(s) to test, evaluate, develop, or determine mechanism of action of agents or interventions to prevent or treat autoimmune disease by induction of tolerance or immune modulation. While industry has supported some translational activities, industry-supported trials have generally not focused on the basic mechanisms of action of these agents.  Collaboration of the Autoimmunity Centers of Excellence with industry in performance of clinical trials/mechanistic studies and autoimmune disease research is encouraged.

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

The ACE Program will NOT support:

ACE Program Components

Each ACE application must include the components described below:

1.      a Clinical Component, incorporating clinical specialists in several autoimmune diseases to conduct clinical trials and associated mechanistic studies that have been developed by the Center and approved by the ACE Steering Committee (see below);

2.      a Research Component, consisting of two or more individual research projects investigating the mechanisms of autoimmunity, self tolerance, or immune modulation;

3.      a Pilot Research Project with discrete benchmarks of short duration and limited funding; and

4.      one or more Cores that support the work within and among the Centers.

1.  Clinical Component (required)

The Clinical Component will be responsible for the implementation and execution of single- and multi-site clinical trials and associated mechanistic studies.  The description of the Clinical Component should contain sufficient detail to permit an assessment of the ability of the Center to successfully design, develop, and execute single- or multi-site clinical trials. Specialists in at least 3 different disciplines (e.g., dermatology, endocrinology, gastroenterology, neurology, ophthalmology, rheumatology, etc.) must participate.  Within each specialty, applicants must identify one or more autoimmune disease(s) on which the Center will focus. 

The description of the Clinical Component must include (a) demonstrated evidence of the capability of the Center to perform clinical trials, and (b) two clinical trial concepts. 

a)     Clinical Trial Capability

Applicants must provide evidence of the ability of the Center to lead or participate in clinical trials and associated mechanistic studies, including the availability of an appropriate patient population and clinical infrastructure support at the applicant institution. See Section IV.2.B. below for additional application submission information. 

b)     Clinical Trial Concepts

Applicants must propose two potential phase 1 or phase 2 single- or multi-site clinical trials in different autoimmune diseases that the Center could lead.  The trial concepts should balance feasibility and innovation.  The trial concepts should be reasonable candidates for implementation within the 5 year program.  Applicants who propose multi-site trials may assume that other Centers within the ACE network will be able to enroll patients in numbers similar to those of the proposing site.  Each clinical trial concept must be described in the form of a protocol synopsis and must be accompanied by mechanistic studies designed to expand our understanding of the mechanism of action of the agent or intervention (see Section IV.2.B. below for additional application submission information). The protocol synopsis should contain sufficient detail to permit an assessment of the ability of the Center to successfully design, develop, and execute the proposed single- or multi-site clinical trial. Methods of data analysis and sample size justification must be included. Applicants must not submit a detailed, final clinical protocol. A final clinical protocol will be developed prior to study initiation, as indicated in the NIAID Clinical Terms of Award (see Section VI.2.A.1. Cooperative Agreement Terms and Conditions of Award – “Principal Investigator Rights and Responsibilities”).

No budgetary support for the Clinical Component should be requested in the application.  After award, additional resources to support the development and implementation of clinical trials and associated mechanistic studies may be requested from the ACE Steering Committee and paid from the ACE Discretionary Fund (see Section VI.2.A.3.a).   

Statistical, Data Management, Pharmacy, and Clinical Trial Operations Support

NIAID will provide statistical, data collection and management, pharmacy, and clinical trial operations support through a separately-funded Statistical and Clinical Coordinating Center for Autoimmune Diseases Clinical Trials (SACCC-ADCT) contract. Each participating institution will be responsible for providing primary study data to the SACCC-ADCT.  Timeliness and accuracy of submitted data will be monitored by the SACCC-ADCT and evaluated by the Steering Committee.  SACCC-ADCT responsibilities are further described under Section VI.2.A.3. Cooperative Agreement Terms and Conditions of Award – “Collaborative Responsibilities.”

2.  Research Component (minimum 2 research projects required)

Applicants must propose a robust research component describing at least two research projects with up to 5 year research plans and strongly supported by preliminary studies.

All projects must focus on human autoimmune diseases.  Applicants may propose to study disease in animals only if the animal is a highly relevant model of human autoimmune disease with a clear potential to translate findings to the clinic.

3.  Pilot Research Project (required)

Applicants must describe one pilot research project with a 2 year research plan with scope and aims consistent with the goals of the ACE.  The pilot research project should emphasize innovation and need not be supported by preliminary studies.  Benchmarks to be achieved at 18 months must be stated.  These benchmarks will be used by the ACE Steering Committee to measure progress.  The Steering Committee will review the progress of the pilot research projects after 18 months.  Based upon the ACE Steering Committee review, additional support may be provided by the ACE Discretionary Fund to continue the successful pilot research project beyond the initial 2 years.  To be eligible to receive additional discretionary funds, the Pilot Research Project Leader will be required to  provide the ACE Steering Committee with an updated research plan for continued support.  Leaders of successful pilot research projects will be encouraged to apply for NIH unsolicited R01 support.

Support for the pilot research project will be provided from the ACE Discretionary Fund.  Funds requested for the pilot research project should NOT be included in the overall budget of the application.  However, a budget for the pilot research project should be included. 

The pilot research project will be of least consideration in the overall score for the Center’s application.

4.  Core Components

a. Administrative Core (required)

The Administrative Core is responsible for coordinating the Center’s efforts and may sponsor activities to advance the Center’s integration.

NOTE: Applications without the above required components will be considered non-responsive and will not be reviewed.

b. Scientific Cores (optional)

One or more Scientific Cores may be proposed.  Each Scientific Core must be used by at least 2 research projects.  Applicants may indicate whether the Scientific Core will support the studies associated with the clinical component.  However this will not substitute for the requirement that Scientific Cores support 2 research projects. 

Scientific cores are limited to providing standard assays, reagents, technologies, or other available services to ACE investigators.  Scientific Cores must be well justified and clearly non-duplicative of other services or facilities available to ACE investigators.  If during the funding period the use of a Scientific Core is significantly changed through the modification, deletion, or addition of pilot research projects and clinical trials/mechanistic studies, funds may be re-budgeted within the ACE after approval by NIAID.  Scientific Cores may include clinical, technical (e.g., flow cytometry, microarray, microdissection), informatics, or other non-administrative activities that directly support the research program.

If appropriate to the particular ACE, repositories for cells, tissues, reagents, or large data sets may be proposed as Scientific Core activities.  In this case, applications should include methods to obtain, protect, and archive relevant clinical information or family history.  In addition, appropriate informatics capability should be provided to track data and link to other data sets.  A plan for the distribution of samples, reagents, data, and other resources should be included and conform to the NIH policies on data and resource sharing (see Section IV.6. Other Submission Requirements and Information).

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

c. Discretionary Fund Management (DFM) Core (optional): 

Applicants proposing to manage the ACE Discretionary Fund (DF) must include in the application a detailed plan to support the responsibilities associated with the disbursement, administration and reporting on the use of the funds. This Core is optional and will not be considered in the overall evaluation of the application.  Such applications must include a plan for the DFM Core describing: 

(1)   an administrative structure that should include a full-time administrator;

(2)   methods/procedures to support the Steering Committee in soliciting, evaluating, prioritizing, selecting, and monitoring the progress of projects supported by the DF;

(3)   plans for interacting with investigators, both within and outside the ACE network, who are applying for, or in receipt of DFs;

(4)   the experience/qualifications of the DFM core leader and all proposed DFM Core staff;

(5)   proposed procedures, format and timing for reporting on the status of DF use;

(6)   documentation of institutional commitment to the administration of the DF.

A separate budget for the DFM Core must be provided and is not to be included in the total budget of the Center. The DFM Core will be evaluated by the review panel, but will not influence the overall score of the application.

Center External Advisory Board (Center EAB) 

Applicants may propose a Center External Advisory Board (EAB).  Applicants should not contact nor identify individuals who might be invited to serve on the advisory board for their ACE.  Applicants may describe the expertise required for individuals to serve on the advisory board.  For competing renewal applications, if an advisory board exists already, the names of current advisory board members should be provided so that conflicts may be efficiently managed.  An individual may serve on two different Center EABs.  Investigators participating in one ACE may serve as a Center EAB member on another ACE. 

ACE Clinical and Research Representatives

A Clinical Representative and a Research Representative must be identified among the Key Personnel in each Center.  The PD/PI must serve as the Clinical Representative or the Research Representative.  For multiple PDs/PIs, one PD/PI must be selected to serve as the Clinical Representative, and a different PD/PI must be selected to serve as the Research Representative.   One individual may not serve as both Representatives.

The clinical and research components of all Centers will work cooperatively to select, design, and perform the clinical trials and the adjunct mechanistic studies as well as collaborative basic and translational research projects.

Steering Committee

A Steering Committee will be established to direct the collaborative work of the Centers and approve use of ACE discretionary funds.  All major scientific and budgetary decisions will be made by the majority of the voting members of the Steering Committee. To permit comprehensive reporting and discussion by the entire Committee, the formation of subcommittees or working groups and the delegation to them of discrete responsibilities and authorities is strongly encouraged. The Clinical Representative and Research Representative from each ACE will serve as voting members of the Steering Committee. Other voting members will include one NIAID Representative and one representative from the SACCC-ADCT supporting the ACE network.  See Section VI.2.A.3. for a full description of Steering Committee responsibilities.

Discretionary Fund

NIAID plans to set aside approximately $4.9 million in total costs per year in a Discretionary Fund (DF) to support clinical trials and mechanistic studies, pilot research projects, and other group activities such as working groups or subcommittees formed by the Steering Committee with narrow focus and short duration (e.g., establishing immunocompetence criteria or comparing measurements of regulatory T cells).  Members of the Steering Committee may apply for DF support, and they may sponsor proposals from investigators either at their institution or at other institutions.  The ACE Steering Committee will establish the goals, priorities, and evaluation criteria for the use of the DF. Management of the Discretionary Fund will be awarded to a single ACE institution from among successful ACE applicants who proposed acceptable DFM Cores. 

Annual ACE Plenary Meetings

The NIAID will hold an annual two-day plenary meeting to share recent findings and encourage collaborations.  All key personnel are expected to attend and participate.  Funds for travel and accommodations should be included in the budget request for the Administrative Core. The research aims and status of all projects from all Centers will be presented in brief talks.  The highlights from each Center’s recent findings should also be presented.  All annual ACE plenary meetings will be held in the Bethesda, Maryland area.  The initial plenary meeting will be held in Bethesda, Maryland within 2 months of award.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH Multi-project Cooperative Agreement (U19) award mechanism. 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 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, the NIAID has not determined whether or how this solicitation will be continued beyond the present FOA.

2. Funds Available

NIAID, NIDDK, NIAMS, NINDS, and ORWH intend to commit approximately $12.1 million in FY 2009 to fund up to 9 new and/or competing renewal grants in response to this FOA.  An applicant may request a project period of up to 5 years and a budget for direct costs up to $450,000 per year.  Of the $12.1million total, approximately $4.9 million per year will be available in a Discretionary Fund to support clinical trials including associated mechanistic studies, pilot research projects, and other group activities. 

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.

Note that multiple Project Leaders or Core Leaders are not allowed for individual Research Projects, the Pilot Research Project, or the Scientific Cores. The Core Leader(s) of the Administrative Core will be the PD/PI(s) of the overall 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

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 in item (box) 2 only of the face page of the application form and the YES box must be checked.

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 PI may be changed during the project period. The contact 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 (see below under Supplemental Instructions for the Preparation of Multi-project Applications).

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 the Clinical Component – describe modifications to PHS Form 398 instructions on selected items to address specific requirements for this component.

C.   Specific Instructions for the Research Component Projects and Pilot Research Project – describe modifications to PHS Form 398 instructions on selected items to address the collaborative or interactive role of the project.

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

A.   General Instructions

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

Note that pages in excess of the allowed limits will be removed from the application and will not be reviewed.

The order of presentation should be as follows:

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 PDs/PIs of the multi-project application, followed by the Clinical and Research Representatives, Project and Core Leaders of the research component projects, pilot research project, and cores, other key personnel, and then other significant contributors.

When multiple PDs/PIs are proposed, list the Contact PI first, then all additional PDs/PIs in alphabetical order.  Then list all Key Personnel, giving name and organization.

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.

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. A page reference should be included for the budget for each project and each 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.)

Do not include the budget for the Clinical Component, the Pilot Research Project, or the (optional) DFM Core in the Composite Budget.   The clinical trials/studies and pilot research project will be supported through the ACE Discretionary Fund.

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.

150,000

150,000

150,000

150,000

150,000

  750,000

Project 2. Study

175,000

175,000

175,000

175,000

175,000

  875,000

Core A. Admin. Core.

  50,000

  50,000

  50,000

  50,000

  50,000

  250,000

Core B. DNA

  25,000

  25,000

  25,000

  25,000

  25,000

  125,000

Totals

400,000

400,000

400,000

400,000

400,000

2,000,000

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.  Detailed budgets are required within the descriptions of each project and core (see below).

6.      Biographical Sketch Format Page

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

7.      Resources Format Page

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

8.      Program Overview (Research Objectives and Strategic Plan)

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.

Within this overview, applicants must:

If the application is a competing renewal of a prior ACE, this section should also highlight the major accomplishments from the prior funding period.  In addition to discussing results from individual projects and clinical trials/studies, describe the synergy and collaborations that occurred.  For individual projects that will be continued, additional details should be provided in the Progress Report section of the Research Plan within the application for the Research Component (see below Section IV.2.C.7.). Other points to include are: the numbers and quality of publications; whether any patents were filed; if researchers were brought into the study of autoimmune diseases; and how the ACE was managed.

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

For applications designating multiple PDs/PIs, a Leadership Plan must be included and is limited to 3 pages (see item 14 of the PHS 398 Research Plan for additional guidance). The governance and organizational structure of the leadership team and their relationship with the overall ACE should be described, including communication plans, process for making decisions on scientific direction, intellectual property issues, and procedures for resolving conflicts. The roles and shared administrative, technical, and scientific responsibilities for the 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.

10. Checklist

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

11. Appendix

A change in policy limiting Appendix materials began with receipt dates on or after January 3, 2007 (NOT-OD-07-018). http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html .

For each project or core in the multi-project application, 3 publications (see below) plus other approved material are allowed. The Appendix may not be used to circumvent the page limitations of the Research Plan. The Appendix material should be collated as one body of material and submitted on CD only, as indicated below. Each document file must include header information clearly indicating the project or core to which it applies.

Do not include unpublished theses, or abstracts/manuscripts submitted (but not yet accepted) for publication.

Note: Include the URL or PMC submission identification numbers along with the full reference in the Literature Cited section, the Progress Report for Competing Renewals section, and/or the Biographical Sketch section.

Beginning May 25, 2008 and for all subsequent due dates, all paper PHS 398 applications must provide appendix material on CD only, and include five (5) identical CDs in the same package with the application. (See NOT-OD-08-031; http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-031.html

Please note that a summary listing of the items included in the appendix is encouraged but not required.  When including a summary it should be the first file on the CD.

When preparing CDs:

For materials that cannot be submitted electronically or materials that cannot be converted to PDF format; (e.g., medical devices, prototypes, DVDs, CDs), applicants should contact the Scientific Review Officer (SRO) for instructions following notification of assignment of the application to a study section.

B.   Specific Instructions for the Clinical Component 

Except for the requirements below, follow the PHS 398 instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing the Clinical Component.

The Clinical Component portion of the application must include:

Note:  Budgets pages should be omitted.

1.  Cover Page

The Face Page of the PHS 398 Form should not be used as a cover page for the Clinical Component within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about the Clinical Component. A Cover Page must demarcate the Clinical Center Description and each Clinical Trial Concept, and should contain the following information items:

Project Number and Title:  (e.g., Clinical Trial Concept 1. “Rituxan, Tolerance, and Lupus”)

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

Proposed Period of Support:

From: (mm/dd/yyyy - e.g., 07/01/2009)

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

Applicant Organization:

(full address)

2.   Form Page 2

Provide an abstract of the Clinical Component according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should describe how the Clinical Component 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 Clinical Representative, the Research Representative, and the Project Leaders for each of the clinical trial concepts, followed by other key personnel, and then other significant contributors.

3.      Form Page 3

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

4.      Biographical Sketches

Do not place biographical sketches here; they are placed together at the end of the overall application.

5A.  Clinical Center Description (maximum 25 pages)

Clinical Center Capability: Applications must provide evidence of the capability of the Center to conduct clinical trials and associated mechanistic studies.  This section of the Clinical Component should include the following:

a.      Experience in performing clinical trials.   

b.      Information on the potential participants in clinical trials for each of the autoimmune diseases identified:

c.       Information on resources available to assist in conducting clinical trials:

d.      Examples of successful collaborations among basic scientists and clinical scientists.  

5B. Clinical Trial Concepts (2 required, each 10 pages maximum)

Each Clinical Trial Concept must include a protocol synopsis and a brief description of the mechanistic studies that would accompany the trial.   

a. Protocol Synopsis: include the following information (maximum 5 pages):

b. Mechanistic Studies: include the following information (maximum 5 pages):

6.      Appendix

Do not place a separate appendix for the Clinical Component here.  All appendix materials should be collated as one body of material at the end of the application as described above.

C.   Specific Instructions for the Research Component Projects and Pilot Research Project

Except for the requirements below, follow the PHS 398 instructions found at http://grants1.nih.gov/grants/funding/phs398/phs398.doc#_Toc130797900 in preparing each individual Research Project and the Pilot Research Project.

Each individual Research Project and Pilot Research Project must include:

1.      Cover Page

The Face Page of the PHS 398 Form should not be used as a cover page for individual research projects within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing specific information about each Research Project and the Pilot Research Project.  Demarcate each project with a cover page containing the following items (these constitute a subset of the information provided on a PHS 398 Face Page):

Project Number and Title:  (e.g., Research Project 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., 12/13/2007,or "Pending")

(and)

Federalwide Assurance (FWA) number:

Vertebrate Animals: (Yes or No)

If Yes, IACUC Approval Date: (e.g., 11/17/2007, or Pending)

(and)

Animal welfare assurance number:

Proposed Period of Support:

From: (mm/dd/yyyy - e.g., 04/01/2009)

To: (mm/dd/yyyy - e.g., 03/31/2114)

Costs Requested for Initial Budget Period: (e.g. 04/01/2009-03/31/2010)

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

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

Note: Pilot Research Project budget request must not exceed $100,000 per year in direct costs.

Costs Requested for the Entire Budget Period: (e.g., 04/01/2009-03/31/2014)

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

Applicant Organization:

(full address)

2.      Form Page 2

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

List the performance sites where the research will be conducted.

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

3.      Form Page 3

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

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

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

5.      Biographical Sketches

Do not place biographical sketches here; they are placed together at the end of the overall application.

6.      Resources Format Page

Provide information on resources available for the project.

7.      Research Plan (Items 2-5 cannot exceed 25 pages for each Research project and 15 pages for the Pilot Research Project)

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/Progress Report:

A list of publications, manuscripts accepted for publication, patents, and other printed materials will be included elsewhere; do not include that information here.

Item 5 – Research Design and Methods

Describe the research design conceptual or clinical framework, procedures, and analyses to be used to accomplish the specific aims of the project. Unless addressed separately in Item 17 of the Research Plan, describe how the data will be collected, analyzed, and interpreted, as well as the data-sharing plan as appropriate. Describe any new methodology and its advantage over existing methodologies. Describe any novel concepts, approaches, tools, or technologies for the proposed studies. Discuss the potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims. As part of this section, provide a tentative sequence or timetable for the project. Point out any procedures, situations, or materials that may be hazardous to personnel and the precautions to be exercised.

Although no specific number of pages is recommended for the Research Design and Methods section, be as succinct as possible. There is no requirement to use all pages allotted for items 2-5.

8.      Appendix

Do not place a separate appendix here.  All appendix materials should be collated as one body of material at the end of the application as described above.

D.   Specific Instructions for Cores

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

Each Core must include:

1.      Cover Page

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

Core Letter and Core Title:  (e.g., A. 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., 5/14/06, or Pending)

(and)

Federalwide Assurance (FWA) number

Vertebrate Animals (Yes or No)

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

(and) Animal welfare assurance number

Proposed Period of Support

From: (mmddyy, e.g., 07/01/2007)

To: (mmddyy, 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)

2.      Form Page 2

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

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

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

3.      Form Page 3

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

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

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

5.      Biographical Sketches

Do not place biographical sketches here; they are placed together at the end of the overall application.

6.      Resources Format Page

Provide information on resources available for the core.

7.      Core Research Plan (Items 2-5 cannot exceed 5 pages for the Administrative Core, 10 pages for each Scientific Core, and 10 pages for the [optional] Discretionary Fund Management Core.)

8.       Appendix

Do not place a separate appendix here.  All appendix materials should be collated as one body of material at the end of the application as described above.

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 16, 2008
Application Receipt Date: July 15, 2008
Peer Review Date: November, 2008
Council Review Date: January, 2009
Earliest Anticipated Start Date: April, 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:
 
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)
Telephone: (301) 435-9369
FAX: (301) 480-2408
E-Mail: pmehrotra@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:

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)
Telephone: (301) 435-9369
FAX: (301) 480-2408
E-Mail: pmehrotra@niaid.nih.gov

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed. Upon receipt, applications will be evaluated for completeness by the CSR and 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 competing renewal 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 or competing 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/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements and Information

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

Research Plan Page Limitations

See Section IV.2. ”Content and Form of Application Submission” for Research Plan page limitations for the individual ACE components.

Resource Sharing Plan(s)

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

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

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

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

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by 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 high 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.

Review Criteria for the Overall Application

The following items will be considered in the determination of overall scientific merit and priority score for the entire 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 overall score will depend on the perceived ability of the proposed work to advance development of therapies for autoimmune diseases.  The clarity and completeness of the application’s combined components with regard to specific goals, proposed feasibility, and progress towards stated goals are critical.

An application with fewer than 2 scored required Research Projects and the required Clinical Component will be considered "not recommended for further consideration" (NRFC). 

Review criteria for the overall application:

Review Criteria for the Clinical Component, Individual Research Projects, and the Pilot Research Project

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? What is the likelihood that the results of the proposed mechanistic research study will be translated into new approaches for treatment and prevention of autoimmune disease?

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? Is there a focus on human autoimmune disease? If animal studies are proposed to study human autoimmune disease, is that animal disease an excellent model for human disease?  Are there clear paths to translating findings from animal studies to humans?  For clinical studies involving human samples, is the rationale for the relevance of the proposed clinical study to human autoimmune disease sound and with high impact? 

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?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project?

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?

In addition to the above criteria, the following criteria will be applied to applications in the determination of scientific merit and the priority score.

Clinical Component: Is there evidence of ability to perform and participate in clinical trials and associated mechanistic studies?  Have potential participants for clinical trials for selected autoimmune diseases been appropriately identified? Are adequate resources available to assist in the conduct of clinical trials, including availability of dedicated clinics, established clinical trial units, or other clinical infrastructure support? Have successful collaborations among basic and clinical scientists been established to facilitate the translation and interpretation of basic and applied scientific knowledge of autoimmune disease into sound clinical trials? Are the rationale and scientific merit of the proposed clinical trials sound and with high scientific merit?  Is there potential for the clinical trial to advance the treatment or prevention of autoimmune disease? 

Pilot Research Project: Are the plans to monitor success of the Pilot Research Project adequate? Is it feasible to achieve the research goals in 18 months?

The Pilot Research Project will be of least consideration in the overall score for the Center’s application.

Review Criteria for Cores

Administrative Core

Scientific Cores (if applicable)

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 E on Human Subjects in the PHS Form 398).

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 E on Human Subjects in the PHS Form 398).

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.

Discretionary Fund Management (DFM) Core (if applicable)

The Plan for Discretionary Fund Management is optional and will not be factored into determining the overall priority score. The review panel will consider the following criteria:

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.

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).

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

Monitoring Clinical Studies

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

http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.

Federally Mandated Regulatory Requirements for Clinical Trials

Each institution participating in a clinical trial is required to meet DHHS regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents.  At a minimum, these include:

External Advisory Board

After award, the PD/PI may establish a Center External Advisory Board (Center EAB) comprised of up to three (3) individuals.  Investigators participating in one ACE may serve as a Center EAB member on another ACE.  No more than one Center EAB member may be a participant in another ACE program.  The Center EAB will meet annually with Center personnel to evaluate the program and provide advice on future directions.  Meeting costs will be borne by the Center.

Pilot Studies

The PD/PI will be responsible for ensuring that all pilot studies involving human or animal subjects have the appropriate clearances (i.e. IRB, FWA, IACUC, human subjects’ research training, and other required documentation) prior to implementation.

Intellectual Property

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

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

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

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

Discretionary Fund Management

Discretionary funds will be awarded to one ACE institution that will be responsible for managing the Discretionary Fund.  This institution must agree to take responsibility for managing the funds, including the disbursement, administration, and reporting on the use of discretionary funds as approved by the Steering Committee. Discretionary fund expenditures will be restricted until a process for the prioritization, solicitation, review and evaluation of projects and the disbursement of funds is established and agreed upon in writing by the Steering Committee.  Once this process is established, funds will be available for distribution. 

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:

NIAID will provide statistical, data management, and clinical trial operations support through a Statistical and Clinical Coordinating Center for Autoimmune Disease Clinical Trials (SACCC-ADCT) contract that is supported separately by NIAID.  Support will include:

1)      statistical leadership for the design and analysis of clinical trials;

2)      clinical site monitoring and training;

3)      data collection, management and quality assurance programs;

4)      regulatory support for IND and associated regulatory submissions, including serious adverse event data collection, evaluation and report preparation;

5)      distribution and quality control of study products; and

6)      technical and administrative functions of the clinical trial consortiums.

NIAID may also provide regulatory guidance independent of the SACCC-ADCT when the Project Scientist deems it practical and efficient.  It is expected that NIAID will hold the IND for most studies where needed.  A NIAID Representative, not the Project Scientist, will serve as a voting member of the Steering Committee.    

DATA AND SAFETY MONITORING BOARD (DSMB).  The NIAID will appoint an independent Data and Safety Monitoring Board to monitor the endpoint and safety data for all trials/studies conducted by ACE awardees.  Depending on the study, the DSMB may function as an independent data and safety monitoring committee.  The DSMB will provide oversight on an ongoing basis, but at least once a year.  The DSMB is advisory to the NIAID. A summary of DSMB recommendations will be provided to investigators.  The DSMB will be funded separately from the ACE. 

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

2.A.3.a  Steering Committee

A Steering Committee will be established to serve as the governing board of the ACE program, to direct the collaborative work of the Centers, and determine the use of the ACE Discretionary Fund.  All major scientific and budgetary decisions will be determined by the Steering Committee, with each member having one vote. To permit comprehensive reporting and discussion by the entire Committee, the formation of subcommittees and the delegation to them of discrete responsibilities and authorities is strongly encouraged.   

The Clinical and Research Representatives, the NIAID Representative, and a representative from the SACCC-ADCT will be permanent members of the Steering Committee.  The NIAID Representative will serve as the voting member for the Government.  The permanent members will choose an additional two (2) members from among the key personnel at participating Centers to join the Steering Committee and complement their collective expertise.  These two (2) additional members will serve one year, renewable terms.  

The Chair of the Steering Committee will be selected by the Steering Committee from among the non-Federal members during the first meeting, to be convened by the NIAID Representative. 

The Committee will meet twice each year in person and monthly by teleconference.  Use of internet-enabled collaborative tools, including websites, email, conferencing, web logs (blogs), and community-moderated discussions is strongly encouraged.  A public website for the ACE (www.autoimmunitycenters.org) and a password-protected secure site will be maintained by the SACCC-ADCT.  

The Steering Committee will:

The clinical and research components of each Center must be willing to work cooperatively and collaboratively both within their Center and with other Centers.  Clinical trials/studies will proceed into the implementation stage only with the concurrence of the Steering Committee and the NIAID Project Scientist.  The majority vote of the Steering Committee decides which group activities the DF will support.

2.A.3.b  Annual ACE Plenary Meetings

The ACE will hold an annual 2 day plenary meeting to share recent findings and encourage collaborations.  All key personnel are expected to attend and participate.  The research aims and status of all projects from all Centers will be presented in brief talks.  The highlights from each Center’s recent findings should also be presented.  The initial plenary meeting will be held in Bethesda, Maryland within 2 months of award. 

2.A.3.c  Steering Committee External Advisory Board

The Steering Committee will select and invite at least two members of the autoimmunity research community to attend the Annual Plenary Meeting and to offer informal, non-binding advice on the progress and goals of the ACE.  Travel and accommodations for the External Advisory Board will be provided through the ACE Discretionary Fund.  ACE applicants should NOT name potential Steering Committee External Advisory Board members.

2.A.3.d. Data Coordination and Management

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

The Steering Committee will determine how data from multiple Centers collaborating on a study will be analyzed.  Centers wishing to perform their own analysis of local data or of single site studies must obtain approval for the planned analysis from the Steering Committee.

2.A.3.d Publication and Presentation of Clinical Trials/Studies Findings

The Steering Committee will establish procedures for the publication and oral presentation of results or data collected within the Centers network.  The results of any collaborative work must be approved by the Steering Committee before it is made public.  Publications and oral presentations of work performed under this agreement should acknowledge support by the Autoimmunity Centers of Excellence and NIAID. 

Awardee members of the Steering Committee will be required to accept and implement policies approved 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. The members shall be: (1) one designee of the Steering Committee chosen without NIH staff voting, (2) one NIH designee, and (3) one designee with expertise in the relevant area who is chosen by the other two members. 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

The PD/PI(s) of each ACE will be responsible for organizing an annual report on all of the activities of their Center to be presented at the Annual ACE Plenary Meeting.   The lead investigator on clinical trials/mechanistic studies will be responsible for providing monthly status reports to NIAID and an annual report to the Steering Committee.    

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) 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:

NIAID

David R. Johnson, Ph.D. 
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3034, MSC-6601
6610 Rockledge Drive
Bethesda, MD  20892-7640
Telephone: (301) 496-7104
FAX: (301) 480-1899
E-Mail: drjohnson@niaid.nih.gov

NIAMS

James Witter MD, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701 Democracy Blvd., Suite 800
Bethesda, MD 20892
Telephone: (301) 594-1963
Fax: (301) 480-4543
E-mail: witterj@mail.nih.gov

NIDCR

Alicia Dombroski, Ph.D.
Division of Extramural Activities
National Institute of Dental and
Craniofacial Research
Room 660, MSC 4878
6701 Democracy Blvd.
Bethesda, MD  20892-4878
Telephone:  (301) 594-4800
Fax:  (301) 480-8303
E-Mail:  adombroski@mail.nih.gov

NIDDK

Beena Akolkar, PhD
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 6105
Bethesda, MD 20892
Telephone: (301) 594-8812
FAX: (301) 480-3503
E-Mail: akolkarb@niddk.nih.gov

NINDS

Ursula Utz, Ph.D., MBA
Program Director
NINDS, NIH
6001 Executive Blvd, Room 2134
Bethesda, MD 20892-9521
Telephone: (301) 496-1431
FAX: (301) 480-2424
Email: utzu@ninds.nih.gov

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)
Telephone: (301) 435-9369
FAX: (301) 480-2408
E-Mail: pmehrotra@niaid.nih.gov

3. Financial or Grants Management Contacts:

Maggie C. Wells
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases 
Room 2250, MSC-7614
6700-B Rockledge Drive 
Bethesda, MD  20892-7614 
Telephone: (301) 594-9847
Fax: (301) 493-0597
E-mail: wellsmaggie@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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