Part I Overview Information


Department of Health and Human Services

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

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

Title:  Immune Defense Mechanisms at the Mucosa Cooperative Study Group (U01)

Announcement Type
This is a reissue with modifications of RFA-AI-08-020.

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

Request For Applications (RFA) Number:  RFA-AI-10-008

Catalog of Federal Domestic Assistance Number(s)
93.855

Key Dates
Release Date: April 23, 2010
Letters of Intent Receipt Date(s): September 22, 2010
Application Receipt Dates(s): October 22, 2010
Peer Review Date(s): February, 2011
Council Review Date(s): May, 2011
Earliest Anticipated Start Date:  July, 2011
Additional Information To Be Available Date (Url Activation Date): http://www.niaid.nih.gov/ncn/qa/revniaid.htm
Expiration Date: October 23, 2010

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

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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. Dispute Resolution 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) invites cooperative agreement grant applications from institutions proposing studies to break new ground in understanding of immune defense mechanisms and immune regulation at the mucosal surfaces.  The purpose of this program is to discover and define novel basic immune mechanisms, cells, mediators, and pathways that provide a more sophisticated understanding of mucosal immune defense mechanisms; to explore innovative hypotheses; and to address difficult unsolved questions in mucosal immunity. The ultimate goal is to develop the knowledge base needed to facilitate future development of vaccines and immunotherapies to protect mucosal surfaces from infection and immune-mediated pathology. This program is not intended to support evaluation of mucosal vaccines or therapies, or research primarily focused on pathogens.

Background

The mucosal epithelium, with a combined surface area more than 100 times larger than skin, is both an initial barrier to pathogen entry and the primary site of entry for many pathogens (e.g. influenza virus, human immunodeficiency virus, herpes simplex virus, enterotoxigenic Escherichia coli, Vibrio cholerae). Since most pathogens first contact the host through the mucosal surface, and efficient person-to person transmission of many pathogens results from an initial mucosal infection, development of vaccines and therapies that target and protect mucosal surfaces would be a significant achievement. Despite several successes in mucosal vaccination (e.g. oral polio vaccine, FluMist, RotaRix, oral cholera vaccine), and substantial research devoted to mucosal vaccine development, the critical elements required for protective mucosal immunity are not well understood.

The mucosal immune system must satisfy a range of diverse requirements from maintaining sterility in the lungs and upper reproductive tract to coexisting with up to 1014 bacteria in the colon. An imbalanced mucosal immune response to food, to the normal microbial flora, or even to pathogens can lead to chronic inflammation and possibly death, so responses at the mucosa require tight controls. Recent studies have provided new clues about the strategies and cellular and molecular components used at different mucosal surfaces to detect and respond to pathogens without causing chronic inflammation, but much remains unknown.

In January 2008, the NIAID sponsored a workshop to discuss recent research advances in mucosal immune defense mechanisms. The workshop participants concluded that multiple gaps exist in the understanding of the basic immune mechanisms responsible for induction of broad systemic and mucosal immunity, priming, protection, and tolerance. These gaps hamper progress in developing therapeutic and vaccination strategies to provide mucosal and systemic protection from mucosal pathogens and inflammatory diseases.

Research Objectives and Scope

This FOA will support a cooperative study group focused on research to define fundamental aspects of immunity at mucosal surfaces. This FOA is intended to stimulate new basic and applied research that will contribute toward understanding broadly applicable host mechanisms of mucosal immune defense. If infectious organisms/vaccines/adjuvants are used for the proposed studies, they must be as model agents to probe host mucosal immune responses to discover new information about mechanisms of immunity.

Areas of interest and examples of research studies responsive to this FOA include, but are not limited to those listed below. Many of the following areas of investigation are not new, but advances in the past few years now suggest that these areas have matured to a level where directed research efforts can have impact. These and other research areas may be addressed in this FOA in the context of defining new mechanisms relevant to immune responses at the mucosa.

Mucosal Epithelium. Mucosal surfaces are separated from the external environment by tightly joined epithelial cells that provide both a physical barrier between the body and the microbial flora and also a first line of immune defense against microbial invasion. Mucosal epithelial cells secrete a wide array of substances such as mucins, defensins, trefoil peptides, cathelecidins, lysozyme and nitric oxide, which non-specifically shield the mucosa from microbial damage. Epithelial innate immune receptors such as TLRs and Nod molecules recognize more defined microbial motifs to signal production of cytokines and chemokines that activate and mobilize immune cells. Epithelial adhesion molecules participate in cell trafficking and localization of mucosal lymphocytes; polymeric Ig receptors and neonatal Fc receptors transport antimicrobial antibodies across the epithelium; and specialized follicle associated epithelial cells play a role in antigen sampling. Although the myriad of active roles mucosal epithelial cells play in host defense have begun to be recognized, many questions remain including the importance of each role in maintaining homeostasis with the host flora versus protection against pathogen invasion. How epithelial cells interact with and respond to commensals and pathogens, and the resultant elaboration of factors involved in immune cell recruitment and function are examples of research areas that still need to be addressed. Examples of potential research studies in this area include, but are not limited to:

Mucosal IgA and Mucosal B Cell Responses. IgA isotype antibodies dominate the mucosal surface and are considered a first line of defense against microbial invasion through the mucosa. Despite the abundance of IgA, and discoveries that have provided a framework for understanding induction of IgA B cells and transport of IgA across the epithelial barrier, much still remains unknown about the source and function of IgA. For example, mouse models of deficiencies in IgA or components of IgA transport or secretion provide conflicting evidence for the requirement of IgA for protective responses to mucosal pathogens. Recent evidence supports new roles for IgA in maintaining homeostasis with the normal flora and prevention of inflammation triggered by the normal flora and harmless antigens. Also, there is now evidence to suggest that IgA switch recombination may occur at non-traditional sites such as the lamina propria and that epithelial cell cytokines can influence this recombination. To facilitate mucosal vaccine development, more information is needed to understand where and how local IgA is produced, and to identify the precise role for IgA in protection from infectious pathogens and maintaining a balance with commensal microbes. Examples of research studies in this area include, but are not limited to:

Mucosal Antigen Sampling and Presentation. The mucosal immune system requires specialized mechanisms to access inhaled or ingested antigens which are separated from the submucosal immune tissues by a tight epithelial cell barrier.  A specialized follicle-associated epithelium (FAE) contains “gateway” epithelial cells, the microfold or M cells, which overlay Peyer’s patches in the gut and the nasopharynx-associated lymphoid tissue (NALT) of the respiratory tract. M cells transport antigens to intraepithelial dendritic cells (DC) in the pockets below the M cells to initiate antigen specific immune responses. More recent studies support the presence of lamina propria DCs that express tight junction proteins and directly sample the luminal compartment by extending dendrites between epithelial cells. In addition, new studies have revealed that the mucosal DC population is comprised of several subpopulations with distinct phenotypes and functions, and these populations vary depending on their precise location within the gut, airway, reproductive tract or other mucosal site. Different mucosal DC subsets have been shown to promote differentiation of B cells into IgA secreting cells, induction of regulatory T cells, or induction of Th17 cells. These new findings imply that mucosal DCs play a key role in orchestrating the balance of effector responses to mucosal pathogens and homeostasis with the microbial flora. The mechanisms, cells, and pathways governing presentation and detection of mucosal antigens in promoting either a protective or tolerogenic host response are important areas for further study. Examples of research studies in this area include, but are not limited to:

Mucosal Immunity and Inflammation.  The mucosal immune system is challenged to respond to harmful organisms while regulating the resultant influx of immune cells to prevent inflammatory tissue destruction. In the gut, several lines of evidence support the idea that the commensal flora exert an anti-inflammatory influence on the mucosa. Alterations in the normal homeostasis with the microbial flora may lead to inappropriate responses in which commensal microbes serve as surrogate pathogens and thus stimulate a chronic inflammatory response. In the relatively sterile surfaces of the respiratory airways, failure to tightly control immune responses to invasive pathogens can also lead to chronic inflammation and tissue destruction. To limit inflammatory responses, the airways, gut and other mucosal surfaces employ a range of complex physical, innate, and adaptive immune defenses to prevent infection. Alterations of any of these defenses could promote an intemperate inflammatory response that while limiting infection may cause tissue injury. The complex mucosal systems to prevent responses to harmless antigens and limit inflammatory responses to pathogens are not well understood and are an important area for further study.

Examples of research studies in this area include, but are not limited to:

The Immune Defense Mechanisms at the Mucosa Cooperative Study Group program is intended to support studies that break new ground in the understanding of mucosal defense and mucosal immunoregulation.  Proposed studies may include mucosal microbes/pathogens/vaccines/adjuvants/infections as probes to gain new insights into mucosal immune defense mechanisms.

Examples of research areas NOT supported by this FOA are listed below. Applications containing research in these areas will be considered non-responsive and will not be reviewed.

New investigators and established investigators working in fields not traditionally directed toward mucosal immunity, as well as new and established investigators already working in the field, are encouraged to apply as PIs or as part of a multidisciplinary teams that open up new collaborations in novel directions.  Investigators new to any research field can introduce new ideas, approaches and technologies that address the difficult questions remaining in immune defense mechanisms at the mucosa.

Additional Information and Requirements

Steering Committee.  A Steering Committee composed at a minimum of the Principal Investigators of each of the awarded grants and an NIH Project Scientist serving as representative of the NIH will be established to direct the overall efforts of the Cooperative Study Group. The Cooperative Study Group refers to the collective research group of all investigators  involved in each of the U01 projects awarded through this FOA. The Steering Committee will be responsible for development and implementation of the Study Group Plan (see below), and will make recommendations for continuation or redirection of ongoing projects, incorporation of additional expertise or resources needed for accomplishing project or program goals, and extensions and modifications to the Study Group Plan. The Steering Committee will be responsible for developing the plan to solicit, receive, and review projects to be supported by the Infrastructure and Opportunities Fund. All major scientific and budgetary decisions on the use of the Infrastructure and Opportunities Fund (see below) will be made by majority vote of the Steering Committee members.

Infrastructure and Opportunities Fund.  An Infrastructure and Opportunities Fund (IOF) will be made available after award to create a shared research infrastructure and to support a range of innovative, collaborative, and pilot/feasibility projects consistent with the goals of this Program and the Study Group Plan. These projects may be submitted by members of the Cooperative Study Group or by outside investigators.

Study Group Plan.  After award and formation of the Steering Committee, the Steering Committee will be responsible for development of the Study Group Plan, which will articulate the goals, specify the approaches, and define milestones for the research activities of the Cooperative Study Group. The purpose of the Study Group Plan is to set an overall agenda for the Cooperative Study Group’s activities designed to produce maximum progress in the field of mucosal immune defense.

Infrastructure and Opportunities Fund Management Plan

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

See Section IV.6 for additional information on FOA-specific application requirements, including the IOF Management Plan.  Applicants are encouraged to discuss any questions with the Scientific/Research Contact listed in Section VII.1 below.

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 cooperative agreement (U01) award mechanism(s). The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

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

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".  At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present FOA.

2. Funds Available

The estimated amount of funds available for support of 7-9 projects awarded as a result of this announcement is $4.0 million for fiscal year 2011. Future year amounts will depend on annual appropriations.  A portion of the available funds will be used for an Infrastructure and Opportunities Fund (IOF) to support additional projects and activities as determined by the Cooperative Study Group.  For more information on the IOF, please see Section IV.6 Other Submission Requirements and Section VI.2.A.3. Collaborative Responsibilities.

Requested annual direct cost amounts for individual awards are expected to range between $200K and $250K.  The total project period for an application submitted in response to this funding opportunity may not exceed 5 years.

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. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

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

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

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

Section IV. Application and Submission Information


1. Address to Request Application Information

The current 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

Prepare all applications using the PHS 398 application forms and in accordance with the PHS 398 Application Guide (http://grants.nih.gov/grants/funding/phs398/phs398.html).

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

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

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

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

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

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

Applications with Multiple PDs/PIs 

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

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

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

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

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

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date(s): September 22, 2010
Application Receipt Dates(s): October 22, 2010
Peer Review Date(s): February, 2011
Council Review Date(s): May, 2011
Earliest Anticipated Start Date:  July, 2011

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:

B. Duane Price, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3139, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616

(For Express Mail:  20817-1821)
Telephone: (301) 451-2592
FAX: (301) 480-2408
Email: pricebd@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:

B. Duane Price, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3139, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616

(For Express Mail:  20817-1821)
Telephone: (301) 451-2592
FAX: (301) 480-2408
Email: pricebd@niaid.nih.gov

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

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

When clinical studies are a component of the proposed research, awards will be subject to the NIAID Clinical Terms of Award (information available at http://www.niaid.nih.gov/ncn/sop/ctoa.htm).    

Expenditure of any Infrastructure and Opportunities Funds allocated to the Cooperative Study Group under this RFA will be restricted to projects approved by the Steering Committee as meritorious and consistent with the goals of this program and the guidelines of the Study Group Plan (see Section VI.2.A.3). Any Infrastructure and Opportunities Funds will be restricted until the Infrastructure and Opportunities Fund expenditure report is submitted and accepted by NIAID staff.

6. Other Submission Requirements

Infrastructure and Opportunities Fund Management Plan

Each application must include a plan for the administration of the Cooperative Study Group’s Infrastructure and Opportunities Fund (IOF). It is anticipated that the IOF management award will be made to one awardee, with subsequent funding decisions determined by the Steering Committee.  See Section VI.2.A.3 for more information on IOF management. This Plan must address, at a minimum:

Additional Budget and Justification Requests

In the budget section of the application and in addition to the costs associated with the proposed research, applicants must include a budget and budget justifications to support:

PHS398 Research Plan Sections

All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:

Budget

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

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

Appendix Materials

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

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

Resource Sharing Plan(s)

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

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

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

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

As part of the Terms and Conditions of this award:

It is expected that all animal models developed with funds from this FOA will be made available to the research community in a timely manner. Applicants may request funds in their application to cover costs related to deposition of these models into existing public repositories (shipping, re-derivation, etc), such as:

Specific Instructions for Foreign Applications

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

Section V. Application Review Information


1. Criteria

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

2. Review and Selection Process

Review Process

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

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

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

Overall Impact

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

Scored Review Criteria

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

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Will the proposed studies provide a more sophisticated understanding of mucosal immune defense mechanism, explore novel hypotheses, or address difficult unsolved questions in mucosal immunity?

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

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

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

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

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

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

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

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

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

Resubmission Applications.  Resubmission applications are not applicable to this FOA.

Renewal Applications.   Renewal applications are not applicable to this FOA.

Revision Applications.  Revision applications are not applicable to this FOA.

Additional Review Considerations

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

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

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

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

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

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

Selection Process

The following will be considered in making funding decisions:

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.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

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

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

2.A. Cooperative Agreement Terms and Conditions of Award

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

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

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator(s) will have the primary responsibility for:  all aspects of the proposed studies. All investigators funded under this FOA, including recipients of Infrastructure and Opportunities Fund awards, are required to accept and implement policies and activities approved by the Steering Committee. All PIs funded under this FOA including those supported by Infrastructure and Opportunities Fund awards are required to participate in an annual meeting. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the Immune Defense Mechanisms at the Mucosa Cooperative Study Group and the NIAID. Timely publication of major findings is expected, and investigators are to submit manuscripts to the NIAID Program Officer promptly upon acceptance for publication. Publication of findings linked to clinical trials (for example, mechanistic studies that utilize samples from a clinical trial) must adhere to the policies enacted by the governing body of the clinical trial and the sponsor of the trial.

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 staff assistance will be provided by a Program Official from the Clinical Immunology Branch, Division of Allergy, Immunology and Transplantation, NIAID, and/or an appointed designee, who will serve as the NIAID Project Scientist. During the performance of this award, the NIAID Project Scientist, with assistance from other scientific staff who are designated based on the research topic and their relevant expertise, may provide assistance, advice, and guidance by: participating in the design of the activities of the Cooperative Study Group; advising in the selection of sources or resources; advising in project management and technical performance; serving as liaison to other mucosal immunity-related NIH programs; recruiting external advisors to the Cooperative Study Group from the international mucosal immunity research community and soliciting their advice and attendance at Cooperative Study Group meetings; and participating in the preparation of publications for collaborative projects, as appropriate. However, the role of the NIAID Project Scientist will be to facilitate, and not to direct, the activities of the Cooperative Study Group. It is anticipated that decisions in all activities will be reached by consensus and that funding agency staff will be given the opportunity to offer and/or solicit ideas and opinions during this process. The manner of reaching consensus and the final decision-making authority will rest with the Cooperative Study Group Steering Committee.

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

2.A.3. Collaborative Responsibilities

Steering Committee

A Steering Committee will serve as the governing body of the Cooperative Study Group and will be responsible for development and implementation of the Study Group Plan (see below). At a minimum, voting members of the Steering Committee will be composed of the Principal Investigators of each of the awarded grants, and the NIH Program Official serving as a representative of the funding ICs and agencies. The Steering Committee and/or the NIH may identify and appoint other non-voting members, as appropriate. A Chairperson will be selected by the Steering Committee from among the non-federal Committee members. Subcommittees of the Steering Committee may be established as necessary. The Steering Committee will meet face-to-face at least twice in the first year and at least annually thereafter. The NIAID Project Scientist will schedule the meetings of the Steering Committee and actively assist the Chairperson in developing the meeting agendas. Each Steering Committee member will be expected to participate in all meetings and other Steering Committee activities, such as conference calls and subcommittee meetings, as may be necessary to accomplish the work of the Cooperative Study Group.  Each full member will have one vote.  

The Steering Committee will also be responsible for ensuring that the activities of all Cooperative Study Group members are coordinated, productive, collaborative when appropriate, and directed toward the goals expressed in the Study Group Plan and the overall goal of breaking new ground in the understanding of basic mucosal immune defense mechanisms that would facilitate future development of vaccines and immunotherapies to protect mucosal surfaces from infection and infection-induced immunopathology.  The Steering Committee will convene investigator meetings to which PIs and appropriate Cooperative Study Group investigators are invited to facilitate review of the progress of all projects on an annual basis. The NIAID may also invite external experts in the field of mucosal immunity to attend these meetings for the purpose of providing additional advice to NIAID. The Steering Committee will make recommendations for continuation or redirection of ongoing projects, incorporation of additional expertise or resources needed for accomplishing project or program goals, and extensions and modifications to the Study Group Plan.

An Infrastructure and Opportunities Fund will be available to the Steering Committee to  support:

1) Cooperative Study Group activities and collaborative projects consistent with the goals of this program and the Study Group Plan

2) innovative pilot and feasibility projects

3) development of reagents and resources, including cooperative resources, required to accomplish the goals expressed in the Study Group Plan

The Steering Committee’s responsibility to conduct and oversee these activities is intended to encourage those cooperative and collaborative efforts, among Cooperative Study Group members and the research community at large, that are best suited to achieve the goals of the program and to advance the understanding of immune defense mechanisms at the mucosa.  As part of this effort, the Steering Committee will devise and implement means to make the immunology research community aware of the Cooperative Study Group’s Infrastructure and Opportunities Fund program and to ensure appropriate participation by researchers outside the Cooperative Study Group.

Study Group Plan

After award and formation of the Steering Committee, the Steering Committee will be responsible for development of the Study Group Plan, which will articulate the goals, specify the approaches, and define milestones for the activities of the Cooperative Study Group. The purpose of the Study Group Plan is to set an overall agenda for the Cooperative Study Group’s activities designed to produce maximum progress in the field of mucosal immune defense. It is anticipated that development of an optimal plan will involve consultation with experts from the international mucosal immunity research community, as facilitated by the NIAID Project Scientist. The initial Study Group Plan will outline critical areas to be addressed through collaborative, coordinated, and/or pilot projects as described above. As part of the Steering Committee’s annual review of all Cooperative Study Group projects and activities, the Study Group Plan will also be reviewed and modified as necessary to address new opportunities and problems in the field.

2.A.4. Dispute Resolution 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 Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

3. Reporting

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

The awardee will submit an annual report, in paper and/or electronic format, to the NIAID Program Officer containing at a minimum the following information:

This report will be due each year on the same date as the Non-Competing Continuation Grant Progress Report (PHS 2590) for the Cooperative Study Group awards.

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:

Annette L. Rothermel, Ph. D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 6617, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-7104
FAX: (301) 480-1450
Email: arothermel@niaid.nih.gov  

2. Peer Review Contacts:

B. Duane Price, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3139, MSC-7616
6700B Rockledge Drive
Bethesda, MD 20892-7616

(For Express Mail:  20817-1821)
Telephone: (301) 451-2592
FAX: (301) 480-2408
Email: pricebd@niaid.nih.gov

3. Financial or Grants Management Contacts:

Laura Amidon
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2240, MSC-7614
6700B Rockledge Drive
Bethesda, MD 20892-7614

Telephone: (301) 451-2687
FAX: (301) 493-0597
Email: amidonl@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.

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

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/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-09-116.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

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

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

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

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


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