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EXPIRED

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 Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)

Title: Environmental Health Sciences Core Center Grants (P30)

Announcement Type
This is a reissue of RFA-ES-07-008.

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

Request For Applications (RFA) Number: RFA-ES-09-002

Catalog of Federal Domestic Assistance Number(s)
93.113

Key Dates
Release Date: January 21, 2009
Letters of Intent Receipt Date: February 28, 2009
Application Receipt Date: March 27, 2009
Peer Review Date: July 2009
Council Review Date(s): January 2010
Earliest Anticipated Start Date: April 1, 2010
Additional Information To Be Available Date (Url Activation Date): Not Applicable
Expiration Date: March 28, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
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

The National Institute of Environmental Health Sciences (NIEHS) invites applications from qualified institutions for support of the Environmental Health Sciences Core Centers. These Centers are designed to build infrastructure in the field of environmental health sciences, including those needed to conduct basic, translational, clinical and public health research. By facilitating the use of shared research resources that serve the research in the mission areas of the NIEHS, investigators who are associated with EHS Core Centers will be poised to lead the field in new and important directions. The mission of NIEHS is to improve human health by using environmental sciences to understand human biology and human disease.

A P30 Core Center Grant is an institutional award, made in the name of a principal investigator, to bring together multidisciplinary groups of scientists to identify scientific opportunities and tackle compelling problems in environmental health sciences. By supporting centralized resources and facilities and fostering scientific exchange, new technologies and approaches can be brought to bear on new and existing research projects. The P30 Core Center Grant is awarded competitively, initially for up to four years, and may be renewed for periods of up to five years. By providing a Center structure and Core resources, this support is intended to enhance the productivity of traditional research grants at the institution, focus investigators on environmental science issues relevant to human biology, human disease, and public health, and thereby improve the health of communities and the nation. A Core Center Grant helps to integrate and promote research in existing projects and provides an administrative framework within one or several central themes; however, no funds are provided for direct support of research projects, except for pilot projects, recruitment of select new investigators, and research program development.

The Core Centers are expected to identify promising opportunities for collaboration and support which would translate environmental health research and related basic science into domains which enhance our understanding of human disease and public health. The Core Center, thus, is charged with recognizing unique opportunities and capitalizing on them to foster scientific excellence using new methods, technologies, and novel scientific approaches that focus on using environmental health science to understand human biology and disease. The emphasis should be on fostering scientific excellence by providing resources and scientific interactions unlikely to be attained by individual investigators, promoting collaborations among basic biomedical and applied researchers, reaching out to innovative investigators in complementary fields, and facilitating cutting edge research that addresses exposures and health issues in a timely manner.

In addition to support services for research, the Center should foster career development for future research leaders in environmental health sciences. This can include training and mentoring junior faculty in environmental health sciences, promoting interactions with established investigators in related disciplines, and helping young scientists and clinician-scientists to build foundations for careers in NIEHS-sponsored research. Investigators and trainees are encouraged to interact with NIEHS program officials with the goal of promoting grantsmanship and eventual funding by NIEHS. NIEHS encourages training and career development of women and underrepresented minorities.

Goals and Expected Outcomes

NIEHS expects that an EHS Core Center will:

Stimulate integration of basic and applied research in order to better understand the impact of environmental exposures on human disease.

Provide intellectual leadership and innovation in basic science, translational and clinical sciences and public health research in environmental health.

Facilitate and develop new interdisciplinary research strategies to advance the field.

Incorporate novel technologies and methods into EHS research.

Provide career development for future research leaders. Membership in the Center should help investigators enhance research and build careers n the fields of basic biology, translational research, clinical research, and public health through mentoring, training, and interactions with programs developed by NIEHS.

Stimulate and support new ideas and collaborations on topics of unique scientific opportunity that are relevant to environmental health sciences.

NIH defines human clinical research as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies. (2) Epidemiologic and behavioral studies. (3) Outcomes research and health services research.

NIEHS defines translational research as efforts along the spectrum of steps that transform scientific discoveries arising from laboratory, clinical, or population studies into clinical or population-based applications to reduce disease incidence, morbidity, and mortality.

General Description and Required Components

The overall goal of the EHS Core Center is to enhance the capabilities of existing programs in environmental health sciences, to assist with building the programmatic and scientific capacity for environmental health sciences, and to support the development of future directions and future leaders needed for the field to mature. The EHS Core Center must be an identifiable organizational unit within a single university, medical center, or a consortium of cooperating institutions with a university affiliation. The EHS Core Center grant mechanism provides core support to foster integration, coordination, and interdisciplinary cooperation among a group of established investigators conducting high-quality research clearly related to the effects of environmental factors on human health. The NIEHS uses this mechanism to integrate and build upon existing programs and institutional resources such as university-wide facilities and services that encourage and enhance research on environmentally-induced disorders. While the EHS Core Center grant provides support for core resources and facilities to be used by Center investigators, it does not provide direct funding for ongoing research projects, although limited funds are provided for pilot projects, support for recruitment, and career development of promising investigators in environmental health sciences.

To qualify for an EHS Core Center the applicant institution must already have a substantial base of ongoing, independently supported, peer-reviewed research projects clearly dedicated to the study of environmental health sciences or environmental medicine, a substantial portion of which should be supported by NIEHS. This currently funded research base provides the major support for a group of investigators who would benefit from shared resources. The research base must exist prior to the submission of an application and will be considered by program staff. Focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity, are all considerations in judging the adequacy of the research base.

Required Components are:

1. Center Director: the designated leader of the EHS Core Center who provides scientific and administrative leadership for the total program. The Center Director is required to commit a minimum of 20% effort to the Center.

2. Administrative Core: oversees organizational, budgeting and reporting aspects and provides the leadership for scientific and programmatic activities of the EHS Core Center.

3. A Pilot Projects Program is required and is considered to be an integral part of the support provided. This program provides modest support for new initiatives or feasibility projects for either new investigators or for established investigators who are moving into research areas of direct interest to the EHS Core Centers. Up to 25% of the budget may be allocated to the pilot projects program.

4. Facility Cores: the major function of the EHS Core Center, shared facilities enhance research or improve cost effectiveness of services, techniques, or instrumentation used by the member investigators. Cores should extend, support, and contribute to the work of the Center members. The facility cores are expected to be dynamic and respond to the needs of EHS Core investigators as these needs evolve. A Center should have a minimum of two facility cores - including the required Integrative Health Sciences Facility Core (see below) - and each facility core must serve at least three users.

The Integrated Health Sciences Facility Core is intended to facilitate translational and clinical investigations, either patient-oriented or population-based research, that enhance translation of basic research findings into practical impacts for patients and communities. Services available through this Core may, for example, provide the opportunity for Center members to obtain clinical samples and patient data needed for their research. These services could also be directed at studies of the etiology, pathogenesis, and prognosis of disease in patient populations.

5. Community Outreach and Education Core (COEC) is optional and serves as a source of information and expertise to the surrounding communities and stakeholders in order to further scientific collaborations and dissemination of research results. If a COEC is included, the Center may request an additional $100,000 annual direct costs.

Recent Changes to the EHS Core Center Guidelines

Changes in Tables A, C, D, and E Simplifications have been made to these tables that are provided to applicants to assist in completion of the application. Applicants are encouraged to download the updated tables from the EHS Core Center Program web page at: http://www.niehs.nih.gov/research/supported/centers/core/guidelines.cfm

As of September 1, 2006, the following change took effect for new and competing applications to the Environmental Heath Sciences Core Centers:

Applications may include up to 10% of the budget - up to $100,000.00 in any one budget period may be dedicated to a Director’s Fund to be used for rapid responses to new and emerging opportunities in environmental health sciences. A direct cost cap of $200,000 is imposed at all times and, with NIEHS approval, EHS Core Centers may carry forward a maximum of $200,000 within the Director's Fund.

As of September 1, 2005, the following changes took effect for new and competing applications to the Environmental Heath Sciences Core Centers:

1. NIEHS merged the NIEHS Core Centers and Marine Freshwater Biology Centers programs into a single program entitled, The Environmental Health Sciences Core Centers Program (EHS Core Centers).

2. Site visits are no longer conducted as part of the review process. Program staff may decide to visit selected applicants to gain further information on which to base funding decisions.

3. The program endeavors to focus investigators to a greater extent on clinical applications, translation, and interdisciplinary research that will have a greater impact on human disease and public health.

4. In order to provide increased flexibility in organization and structure of the EHS Core Center, the Director may develop a dynamic structure which meets the on-going intellectual needs of the Center. This structure can change as the intellectual needs change to accommodate new opportunities for collaboration. Research Cores are no longer required as organizational units in the Center. The proposed Center organization must include the required components outlined above, but, beyond those, no additional structure is imposed by NIEHS.

5. An Integrative Health Sciences Facility Core is required.

6. Community Outreach and Education Cores (COEC) which focus on partnering with stakeholders in order to disseminate EHS Center research results are optional. Centers that choose to develop a Community Outreach and Education Core are eligible for an additional $100,000 direct costs. Kindergarten-Grade12 curriculum development is not allowed as a COEC activity.

7. Page limits apply to the application (see Section IV, Part 6 Other Submission Requirements of this FOA). Applicants can download preformatted tables to facilitate completion of the application from the NIEHS website at http://www.niehs.nih.gov/research/supported/centers/core/guidelines.cfm.

REQUIRED ELEMENTS IN THE APPLICATION

A. Strategic Vision and Impact on Environmental Health

A vision, theme, and set of goals must be developed and described in the application. The Center Director must provide a written strategy for how the Center will implement this vision and which future directions will likely be followed during the project period. The plan will outline the existing skills, technologies and scientific research base and other resources at an institution. This plan should describe how the Core Center will enhance ongoing projects, assist in the introduction of outstanding new projects, respond to future challenges and opportunities, and promote collaborations, advances in technology, and progress in environmental health sciences. The Center Director must detail expected scientific outcomes including a description of anticipated impact on human disease and public health. An organizational chart should be included to illustrate the structure, interactions, and leaders of the Core Center. The application must define, in this section, the eligibility criteria for Center membership and note which individuals play key leadership roles in the Center.

This plan must address the following critical elements:

Theme Provide the central theme(s) of the EHS Core Center and the likely supported research, resources, and relevance to environmental medicine. The theme may be broad or focused, depending upon the goals of the Core Center.

Goals and directions Describe current and future directions for the Core Center in the forthcoming project period. How will the research supported by the EHS Center impact the understanding of environmental health sciences and, ultimately, public health? Describe the short, mid and long-term goals and measures of success. What are the likely advances expected in the field of environmental health and how can these advances be applied to human disease and public health? Describe any basic science work that has successfully been translated to the bedside or community or plans to enhance that translation in the next project period. What expected, widely-applicable research tools and scientific advances will emerge from the Center’s emphasis? Document how the Center will organize and lead the team towards these advances. Identify levels of risk for these goals, potential roadblocks to achieving them, and how the Center might respond to these challenges. Competing continuation applications must also describe the accomplishments of the Center in the preceding project period and how it intends to build upon its successes. These accomplishments should be presented in three areas: basic science, clinical research, and public health. The impact of Center-based science should be discussed in detail.

Integration of investigators of multiple skills and talents Outline steps the Center will take to promote interdisciplinary studies and collaborations, especially among basic scientists and clinical researchers. What types of initiatives will stimulate the teams and attract high-caliber professionals? To what degree will high-risk / high-payoff research that may require long-term support be implemented?

Building research capacity Provide details on the special talents and resources that will be drawn to and built upon at the Center. How will these talents be harnessed and used to promote new collaborations and produce multidimensional teams to address more complex questions? Include a plan for bringing investigators into the Center from within and outside the area of environmental health sciences. What expertise will these individuals share with the Center? Describe academic and research partnerships that will be pursued by the Center to advance its goals and missions.

Provide a plan to determine the need for services and instrumentation of the Center. Address the steps that will ensure that the Core Center proceeds at the cutting edge of technology and concepts. It is expected that facility cores needs may change with time. Include information on the process of re-evaluation of needs and implementation of changes.

Provide a plan to evaluate emerging opportunities in environmental health sciences and describe how the Director’s Fund and other Center resources (facility cores and pilot projects) will be re-deployed to capitalize on exciting new challenges.

Research Cores, if included, are to be discussed within the Strategic Vision. Brief examples of ongoing or planned research should be discussed as appropriate with reference to the supporting Facility Core. Do not provide an exhaustive list of ongoing incremental research. Weave significant findings and advances throughout the narrative of this section to demonstrate the leadership and impact of the center on building its environmental health sciences program.

Plans for a COEC (if included) must indicate how this entity will integrate with the Center and fulfill its mission with the targeted audience(s).

B. Environmental Health Identity and Impact of Research Base

The EHS Core Center grant mechanism fosters interdisciplinary cooperation among established investigators conducting high-quality research in environmental health science. Therefore, existence of a strong research capability in environmental health sciences is fundamental to establishment of a new, or continuation of an existing, EHS Core Center. To qualify for EHS Core Center support, an institution must demonstrate this research capability so as to have a clearly identifiable, major scientific focus in environmental health research. Consequently, an existing program of excellence in biomedical research in the field of environmental health science is a basic prerequisite for establishment of an EHS Core Center. Furthermore, a Center must be able to capitalize upon these research capabilities and resources to advance significantly our understanding of its chosen scientific focus.

At the time of submission of a new or competing continuation application, any institution or consortium wishing to qualify for the EHS Core Center grant must have a minimum of three active NIEHS-supported research grants from three distinct principal investigators. Acceptable grant support includes R01, R21, R37, P01, P42, P50, Cooperative Agreements (U-grants) or Research Career Development Awards (K-grants), not including administrative extensions, either with or without additional funds. Each multi-component (e.g., P01, P50, or U01) award will count as one qualifying research project. A sub-project of a multi-component award (e.g. P01) that is sub-contracted to the applicant institution can be counted only once towards the research base.

Research grant support from NIH and sources other than PHS should be listed and will be considered in the determination of its suitability of focus on environmental health sciences if the research is (1) related to human health in areas where there is evidence for the involvement of environmental factors in disease etiology or phenotypic expression, (2) of outstanding quality, and (3) funded by an entity using peer or internal review of rigor comparable to that of PHS. NIEHS will have the final decision in determining whether the applicant Center Institution has the critical mass of grants, investigators, and projects in the area of environmental health. Prior to submission of an application, the proposed Center Director must consult with Institute Staff regarding the adequacy of the research base.

Applicants must detail grants and funding sources in this section by completing, for example Table A: Grant Support http://www.niehs.nih.gov/research/supported/centers/core/docs/table-a-grantsupport-07.pdf) and by describing environmental health sciences research at the applicant institution(s) that emphasizes the focus, interactions, relationships, and scientific excellence of the projects and investigators and the impact on advancing scientific knowledge relevant to environmental health issues. Include in the Appendix a brief abstract of approximately one half of a page for each project.

Competing continuation applications need to describe how the existing Center facilitated a leading role in environmental health at its home and associated institutions and should document the outcomes and impact of the Core Center on research efforts during the preceding funding period. This should include a summary of research highlights which were accomplished as a result of Center infrastructure and support, how facilities were made available to the maximum number of qualified investigators, the changes in resources that might have been made to accommodate altered user needs and/or increased demand, a composite list of publications, examples of subsequent funding for new directions highlighting collaborations fostered by the Center, and career advances and training outcomes. To assist in preparing the application, Table D1: Publications Resulting from Center Involvement, and, if appropriate, Table D2: Publications Resulting from Pilot Program Funding Applicants, which have been preformatted to facilitate completion, can be downloaded from the NIEHS website at http://www.niehs.nih.gov/research/supported/centers/core/docs/tabled-pubs-07.pdf. Measures of accomplishment also include: pilot projects that led to NIH or other peer-reviewed research applications; new or improved tools, discoveries, or patented inventions (and documentation of the wide use of such tools); training and recruiting of new investigators who have advanced in their careers in environmental health; and, where applicable, outreach to affected communities and appropriate educational outcomes.

C. Center Director

Each applicant institution will specify an experienced and respected Center Director with authority to oversee the organization and operation of the Center and to provide scientific and administrative leadership for the total program. The Center Director should devote at least 20% total effort to the Center. A Deputy Center Director must also be designated to serve in the absence of the Director, with other responsibilities described. The background and scientific and administrative expertise of the Center Director and the Deputy Director should be described fully in the application. For competing applications, an assessment of past performance is required. It is expected that the both the Center Director, as well as the Deputy Center Director will have distinguished records of scientific and administrative accomplishment. In the event that either of these individuals is to be replaced, the new individual would be expected to be a leader of similar talents and abilities.

D. Career Development for Environmental Health Investigators

Emphasis on career development for environmental health scientists is strongly encouraged. The application should address plans that will promote training of new investigators and bring new expertise into the area of environmental health sciences by supporting the career development of established investigators. Specify the plans to cross-train researchers in current techniques that are absent from the EHS Core center or individual research programs. Training and cross-training may include collaborations that will introduce a focus on human subjects and tissues into laboratory-based studies. NIEHS strongly encourages training and career development of women and underrepresented minorities.

The following activities are consistent with this aspect of the EHS Core Center.

1. New Investigator

Temporary salary support (up to 75%) and equipment may be provided in the application for a Named New Investigator in a specified area of research. The investigator can work in the basic sciences, clinical research, or public health disciplines relevant to environmental health. Former post-doctoral assistants and fellows are eligible for this position.

This investigator is eligible to compete for support for up to two years through the pilot project program. Subsequently recruited individuals are to be named by the Center Director and submitted for approval to the Center's Internal or External Advisory Board, as appropriate.

2. Recruited Center Investigators

The EHS Core Center grant may provide partial salary support (up to 75%), technical support, and equipment for independent investigators newly recruited from outside the Center. This mechanism is intended to infuse Center research with novel technologies and approaches by supporting independent investigators, ideally, who are at the beginning stages of their research careers, and will add needed expertise to the Center structure. The recruit would be expected to bring new technologies or novel scientific areas of expertise into the environmental health sciences arena that enhance the Center’s research capabilities. Former graduate students and postdoctoral fellows of Center members should not be considered for support unless, in exceptional cases, it can be demonstrated that they have established independent research careers and will provide critical expertise.

Funds awarded under this section may be used for salary, technical support, and equipment. The remaining salary support for the Recruited Center Investigator must be derived from other than Center funds. For each investigator, the duration of support as a Recruited Center Investigator will be limited to no more than two years. Specific individuals to be awarded Recruited Center Investigator support need not be identified in the application, but the amount budgeted for this purpose should be declared, and, to the extent possible, the types of individuals sought and their expected roles in the Center described. Competing continuation applications should include a discussion of how these funds were used in the previous project period in terms of who was recruited and how these individuals benefit the Center programs.

3. Career Development Activities in Translational and Clinical Research

The EHS Core Centers mechanism encourages clinical and basic scientists with a broad range of skills to work together on a unified theme. Therefore, it presents a rich environment for young translational and clinical investigators to be exposed to and develop additional research skills. Mid-level investigators and scientists in other fields may also be attracted by opportunities in the Center to focus their attention on issues in environmental health sciences and human disease. Financial support can be provided for training and mentoring of physician scientists to study environmental health issues that are relevant to translational and clinical research or public health. In addition environmental health scientists can be supported to engage in activities which increase their understanding of clinical research. The objective of this activity would be to assist new investigators in progressing to more senior status and eventual NIEHS funding by enhancing their research skills and knowledge in translational and clinical research. These activities can be constituted as an independent Facility Core, or as part of the Administrative Core.

The career development activities should be directed by an investigator with strong mentoring credentials who will devote a defined percent effort (5% suggested). To facilitate mentoring and multidisciplinary developmental activities, active involvement by senior investigators within the Core Center is strongly encouraged in an effort to match mentors with candidates. The plan for career development activities will be evaluated in terms of potential effectiveness in developing the skills and research capabilities of investigators as reflected in the following required elements of the application:

A discussion of how mentoring and the professional development of the investigators will be achieved, including their progression to a more independent status.

A plan for monitoring the progress of the career development of selected investigators.

Examples of planned scientific enrichment activities for selected investigators including training experiences, mini-sabbaticals, special lectures, visiting scientist symposia, seminars, workshops, and short courses both at the parent institution or off-site.

In order to increase diversity in the student and faculty populations and the participation of individuals currently under-represented in the biomedical, clinical, behavioral, and social sciences, applicants are encouraged to designate new and recruited investigators from the following groups: women, under-represented racial and ethnic groups; individuals with disabilities; and individuals from socially, culturally, economically, or educationally disadvantaged backgrounds that have inhibited their ability to pursue a career in health-related research.

Direct costs for the sum of career development activities should not exceed $150,000 annually. This figure does not include salary for the Center’s New Investigator or Recruited Center Investigator described above. Assisting new investigators in attaining independent status or established investigators in developing new promising areas of expertise should be an objective of the Core activities. Sponsored participants should be encouraged to apply for NIEHS sponsored Career Development Awards, patient-oriented research grants, or other types of independent support. Contact with NIEHS program staff is encouraged at an early stage in submission of new applications.

E. Institutional Commitment

The Institutional Commitment at the applicant institution will be a major consideration in ensuring the goals of the Core Center. The parent institution should recognize the EHS Core Center as a formal organizational component and provide documented evidence of space dedicated to the needs of Center, protected time to devote to Center activities, staff recruitment, dedicated equipment, or other financial support for the proposed Center. The parent institution should provide assurance of its commitment to continuing support of the EHS Core Center in the event of a change in directorship and a well-defined plan for this eventuality should be in place. In addition, it is expected that the Institution will support the goal of providing to Center members priority access to Institution’s and Center’s facilities and services at minimal cost.

Organizational and Operational Elements of EHS Core Centers

The organization and structure of the EHS Core Center should reflect the goals of the center, encourage collaboration, develop and implement Center-wide initiatives, and promote the use of shared resources and pilot project funds. The structure can change as needed based on new scientific opportunities and partnerships. This major underpinning of the EHS Core Centers allows for modifications of programmatic and scientific activities and areas of support to fully capitalize on the most exciting research opportunities in environmental health sciences.

The application should include a description of the organization and structure of the Center and illustrate all components in an organizational chart.

Center Components

1. Administrative Core

It is expected that organization of the Administrative Core will provide a supportive structure sufficient to ensure accomplishment of the following:

Coordination and integration of Center components and activities.

Assessment of productivity, effectiveness, and appropriateness of Center activities and determination of Center membership assessment of scientific opportunities and areas for collaboration among Center members.

Organization of Center activities, such as retreats, invitation of consultants, meetings, and focus groups.

Organization of the Internal and External Advisory Groups.

Record keeping of meeting minutes and measures of success including: use of EHS Core Center facilities, publications, pilot project awards, and new grant applications resulting from preliminary data enabled by the Center.

Interactions with other Centers, the NIEHS, and other appropriate individuals, groups, or organizations.

The administrative structure must include an Internal Advisory Committee (IAC) and an External Advisory Committee (EAC). Further details for constitution of these committees are available in the complete set of Guidelines for Environmental Health Sciences Core Center Grants http://www.niehs.nih.gov/research/supported/centers/core/guidelines.cfm. Updated September 1, 2005).

Renewal applications must document the functions and effectiveness of the External and Internal Advisory Committees.

The Administrative Core may include a Director’s Fund, with up to ten per cent of a Center’s annual budget (direct costs), to be used in rapid response to special needs and to exploit emerging scientific advances and novel opportunities. Examples of such opportunities include, but are not limited to: recruiting additional investigators or engaging collaborators with needed expertise; fostering translation of advances to the human disease or public health arena; updating equipment to improve the available technology and thereby enhance productivity and scientific discovery; responding to unforeseen events with a direct environmental health connection, or Community and Education Core expenses. Expected uses of these funds should be described in the application. A process for expending the Director’s Fund should be briefly described in the application and input should be sought from the Center's governing boards and external advisors when making allocations. Decisions regarding the Director’s Fund and subsequent outcomes should be described in annual progress reports. No more than $100,000 (direct costs) may be placed within the Director’s Fund in any budget period. In general, no more than $200,000 (direct costs) will be approved for carry-forward within the Director’s Fund.

To assist in preparing the application Table B: Center Members, which has been preformatted to facilitate completion, can be downloaded from the NIEHS website at http://www.niehs.nih.gov/research/supported/centers/core/docs/tableb-members-07.pdf and inserted into this section.

2. Facility Cores

The major function of the Center grant is to support Facility Cores which are designed to furnish groups of Center investigators with techniques, services, or instrumentation that will enhance the research in progress, consolidate manpower effort, and contribute to cost effectiveness. At least three investigators with independently funded projects and demonstrated need for such a core service form the minimum required research base to establish a core facility. Additionally, the minimum of three funded investigator users does not in itself provide sufficient justification for establishment of a Facility Core. The Center must have at least two facility cores. A new requirement is the Integrative Health Sciences Facility Core, which is described below. To assist in preparing the application, Table C: Facility Core Use, which has been preformatted to facilitate completion, is provided and can be downloaded from the NIEHS website at http://www.niehs.nih.gov/research/supported/centers/core/docs/tablec-facilityuse-07.pdf. Separate Tables, such as Table C, are to be provided for each Facility Core.

Facility cores should draw on Center research needs, including, but not limited to: animal use and transgenics, imaging, tissue culture, pathology support, statistical support, oligonucleotide synthesis, analytical chemistry, proteomics, bioinformatics, exposure assessment, and handling of human tissue specimens. Establishment and continued support for Facility Cores by an EHS Core Center application must be justified on the basis of use by independently funded Center investigators. The utilization of Facility Cores by pilot projects is encouraged. Use of core facilities by projects funded by research and development contracts will be evaluated on an individual basis. In general, use of Core facilities by contracts must be paid in full from the contract funds, not from the EHS Core Center grant funds.

Facility cores for the EHS Core Center should be unique and are not to duplicate services or facilities that already exist at the parent or collaborating institutions or can be purchased commercially. University-wide facility cores providing services in areas relevant to environmental health research have become more widely available at many research centers. EHS Core Centers should utilize existing facility cores where appropriate and describe in the application how members of the EHS Core Center would receive priority access, favorable cost arrangements, and training on unique technologies. If facilities within a university-wide facility are not sufficient to meet the needs of the EHS Core Center, then the applicant is to provide information on the existing facilities and on how the Center and greater university facility plan to partner. Proposed Center facility cores that appear to replicate services already available at the applicant institution will not be allowed without extensive justification. Facility cores should not duplicate services that can be purchased in the private sector at prices below University-derived costs.

The application must provide the total operating budget for each Facility Core together with the percentage of support requested from the Center Grant. User logs or similar information used to complete the on-line form should be maintained and made available on request to the NIEHS in order to validate the extent of use and degree of sharing. In the case of new proposed Centers or new Facility Cores within an existing Center, similar information regarding anticipated use of the Cores should be provided. Define the use or expected use of the Facility Core by Center members and/or projects in terms of Low, Medium, or High (on a scale of 1-3).

Each Facility Core must have a designated leader who will be responsible for core activities. The application should explain the organization and proposed mode of operation of each core. It should include a plan for prioritizing investigator use of the core as well as a definition of qualified proposed and potential users. This definition need not be too narrow, since limited use of a core might be an enticement to established investigators in other fields to lend their expertise to the field of environmental health. The use of the Facility Core for training purposes is encouraged, and, if so planned, a description of the extent of and approach to this training should be included.

Although Facility Cores are meant to provide services for Center members, they also play an important role in developing new methodologies, adapting instrumentation for Center needs, and educating Center members of the value and utility of services and methods. Limited funds can be designated to support these aspects of the Facility Cores and discussion of how these activities will be performed should be included in the application.

3. Integrative Health Sciences Facility Core

The Integrative Health Sciences Facility Core is required and should be designed to facilitate the translation of basic research findings into clinical or public health applications. This Core provides new and critical resources and will be a vital component of the progression of environmental health sciences from the bench to the bedside and to affected communities. It is expected that the concepts and goals of environmental medicine will be integrated into the range of activities that the greater Core Center undertakes.

This Core is to be designed to support collaborative efforts among basic scientists, clinical researchers, and/or public health practitioners by:

Providing services and access to instrumentation and technologies that foster integration of basic science, public health research including epidemiology and intervention studies, and patient-oriented clinical research.

Supporting research to improve early detection, prevention, and/or therapy for environmentally related disorders.

Enhancing partnerships between researchers and community based organizations that impact on conduct of clinical and public health research.

Among its functions, the Integrative Health Sciences Facility Core may provide services that capitalize on access to well-characterized patients and control subjects for research projects. These can include study subject recruitment and retention activities, and follow-up by mail, phone or in-person to gather needed data for research projects. Clinical services may include clinical laboratory or other assessments, pathology services, collection, processing and long-term storage of human tissue samples, blood, urine or other biospecimens, and preparation of questionnaires or other assessment tools. The IHSFC can facilitate and support partnerships between study investigators and human populations or communities, health care providers or others. Description of services, equipment, and other activities of this core need to be well documented. When applicable, procedures for collecting, storing, and distributing biological samples should be included in the application. Partnerships with other units at the institution which support these types of activities (e.g. Clinical and Translational Science Awards) are encouraged and letters of support should be included in the application. As for all Facility Cores, the application should include a description of the types of research projects and/or clinical trials that use or plan to use the core. Include specific examples and the likely benefits to other research activities.

For the purposes of the EHS Core Centers, clinical research is as defined by NIH. This definition can be found in the Guidelines for Environmental Health Sciences Core Center Grants at http://www.niehs.nih.gov/research/supported/centers/core/guidelines.cfm.

4. Pilot Projects Program

Inclusion of a Pilot Projects Program is required and is an integral part of the EHS Core Centers. A plan to support pilot studies for basic or clinical biomedical, epidemiological, educational, or behavioral research should be included and budgeted in the application. The description of a plan to solicit, review, and administer pilot grants must be included in the Administrative Core and a separate budget, including the total request for pilots, must be submitted. Criteria for review of pilot studies must be developed and included in the application. Up to 25% of the direct cost budget for each year should be allocated to the Center Pilot Projects Program to support short-term projects to explore the feasibility of new areas of study which leads to collection of sufficient data to pursue support through other funding mechanisms. Include a clear description of the process designed to award and evaluate progress in pilot projects. Investigators are encouraged to consult with NIEHS program staff for submission of new NIH applications based on pilot project-supported data.

Competing continuation applications should provide documentation of the existing pilot projects program. Include the process for application review and award and the measures of success, such as publications, subsequent funding, and career advancement of the sponsored individuals. A competing continuation application should include: historical overview of the Pilot Project Program during the last program period; a description of the management of the program; and a listing of all pilot projects which were supported during the last project period. To assist in preparing the application, Tables E1: Pilot Projects Outcomes and E2: Grant Details for Pilot Projects, which have been preformatted to facilitate completion, are provided and can be downloaded from the NIEHS website at http://www.niehs.nih.gov/research/supported/centers/core/docs/tablee-pilots-07.pdf and inserted into this section.

Pilot projects are primarily intended to:

1. Provide initial support for new investigators to establish new lines of research.

2. Allow exploration of possible innovative new directions representing a significant departure from ongoing funded research for established investigators in environmental health sciences. Ideas of particular importance in environmental health sciences are paramount.

3. Stimulate investigators from other areas of endeavor to apply their expertise to environmental health research and environmental medicine.

4. Foster opportunities that meet goals set out in the EHS Core Center Plan. Pilot projects should strive to fill in gaps in research areas relevant to the scientific focus of the Core Center.

5. Community Outreach and Education Core (Optional Core)

NIEHS Core Centers have the option to develop and sustain community outreach and education activities. The objective of the Community Outreach and Education Core (COEC) is the translation of research information into knowledge for various professional and public stakeholders. Therefore, each Center that chooses to develop a COEC must demonstrate that the objectives, activities, and products are aligned and integrated with the research strengths and focus of their Center.

Programs developed by COECs will lead the field of environmental health outreach and education at the local and national level. To this end, the goals of the COEC are to:

Develop partnerships with stakeholders to translate and disseminate EHS Core Center science.

Work with community-based organizations, disease advocacy groups, and other local, state, or regional partners to enhance the dialogue on environmental health issues in their regions.

Develop and implement appropriate outreach and educational programs to increase awareness and understanding of environmental health research being conducted at the EHS Core Centers.

Evaluate outreach models, disseminate results at local and national levels, and promote models for national implementation.

To meet these goals, it is essential for COECs to state clear and measurable objectives; possess appropriate expertise to fulfill its stated objectives; identify specific environmental problems; demonstrate alignment to research strength and focus of the Center; identify existing and future partners; prioritize short, mid, and long-term activities to be implemented; list and describe expected products; state anticipated impacts and their significance for environmental public health; and define evaluation tools to measure the impact of core activities.

For the purposes of the EHS Core Center Program, there are three target audiences of interest: Community, Policy-makers, and Public Health and/or Health Care Professionals. COECs are required to choose one target audience, but may select more than one. Examples of activities are in the EHS Core Center Application Guidelines at: http://www.niehs.nih.gov/research/supported/centers/core/guidelines.cfm.

Should a Core Center choose to support a COEC:

(a) The COEC is required to establish a Stakeholder Advisory Board to strengthen the bi-directional interaction between the Core Center and partners. The purpose of this advisory group is to ensure Center understanding of community and other stakeholder needs, as well as to insure more effective dissemination of Center research in appropriate venues. The Center should develop a specific plan and set of integrated activities for COEC, particularly with respect to the Center’s defined community and target audience. COEC must be a logical outgrowth of the scientific focus of the Center and exhibit the potential for mutual benefit due to interactions with Center investigators.

(b) COECs must possess the appropriate expertise for the identified target audience and outlined activities. It is important that COECs be directed by staff trained in public health, outreach and education, and other relevant disciplines at a Master’s or Doctoral level.

(c) Collaborations among COECs in EHS Core Centers are desirable. Support of collaborations can be from NIEHS/NIH or other agencies and foundations.

(d) COECs are encouraged to collaborate with NIEHS staff within the Division of Extramural Research and the Office of Communication and Public Liaison in developing printed and audiovisual educational materials. These outreach activities must be identified as programs supported by the NIEHS Core Center. All COEC-produced materials must be submitted to the Community Outreach Resource Center.

(e) Support for appropriate staff positions, travel, equipment, and supplies for this activity is allowed.

(f) Although COEC is not intended to include human subject research, epidemiology, clinical trials, clinical services delivery, or community-based research, the Core may be useful in establishing a relationship with a community-based organization that could form the foundation of a research grant application. In such cases, appropriate COEC proposals may be considered for pilot project funding. The program should not go beyond public and community education concerning environmental disease risk and/or hazard exposure recognition, as the COEC is not intended to give medical, legal, political, social, or economic advice.

(g) K-12 curriculum development is not allowed as a COEC activity.

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 P30 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). Detailed categorical budgets for the "Initial Budget Period" and the "Entire Proposed Period of Support" are to be submitted with the application.

2. Funds Available

The estimated amount of funds available for support of four to five projects awarded as a result of this announcement is $7.2 million for fiscal year 2010. Future year amounts will depend on annual appropriations.

New or first-time applicants can apply for up to four years of support. New applications are limited to requests for no more than $500,000 in direct costs in the first year; $600,000 in direct costs in the second year; $700,000 in direct costs in the third year; and $800,000 in direct costs in the fourth year. An additional $100,000 in direct costs in each year may be requested if a COEC is to be included.

Renewal applications may request up to five years of support and up to $1,000,000 per year direct costs. The application may request up to $1,100,000 per year if it includes a COEC, with a minimum of $100,000 devoted to that core.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Eligibility for award is limited to domestic institutions.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

The applicant institution must have an Identity in Environmental Health Sciences, defined as a substantial base of ongoing, independently supported, peer-reviewed research projects related to the study of environmental health sciences or environmental medicine, a substantial portion of which should be supported by NIEHS. The research base must exist prior to the submission of an application and will be considered by program staff. Focus, relevance, interrelationships, quality, productivity, and, to some extent, quantity, are all considerations in judging the adequacy of the research base. At the time of submission of a new or competing continuation application, any institution or consortium wishing to qualify for the EHS Core Center grant must have a minimum of three active NIEHS-supported research grants from three distinct principal investigators. Acceptable grant support includes R01, R21, R37, P01, P42, P50, Cooperative Agreements (U-grants), and Research Career Development Awards (K-grants), not including administrative extensions, either with or without additional funds. Sub-projects of multi-component grants will count only once and at the level of support of the contributing sub-project only. Support for consultants will not count towards the totals. To assist in preparing the application, Table A: Grant Support, that has been formatted to facilitate completion, is provided and can be downloaded from the NIEHS website at http://www.niehs.nih.gov/research/supported/centers/core/guidelines.cfm. Include in the Appendix a brief abstract of approximately one half of a page for each supported project.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016 Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Applicants may submit a renewal application.

The application must name a Center Director as the designated leader of the EHS Core Center to provide scientific and administrative leadership for the total program. The Center Director must commit a minimum of 20% effort to the Center.

The application must include an Administrative Core to oversee organizational, budgeting and reporting aspects and a framework for leadership of scientific and programmatic activities of the EHS Core Center.

A Center should have a minimum of two facility cores. Facility Cores are shared facilities that enhance or provide cost effectiveness for services, techniques, or instrumentation used by the investigators within the EHS Core Center. Cores should extend, support, and contribute to the work of the Center members. Each Facility Core must have at least three users and be designed to furnish Center investigators with techniques, services, or instrumentation to enhance research in progress, consolidate manpower effort, and contribute to cost effectiveness. A new requirement for the Core Centers is the Integrative Health Sciences Facility Core that is intended to facilitate clinical investigations that would enhance translation of research findings into practical impacts for patients and/or provide the opportunity for Center members to obtain clinical samples and patient data needed for their research. These services could also be directed at studies of the natural history and prognosis of disease in patient populations.

A Community Outreach and Education Core is optional.

A Pilot Projects Program is required. This program provides modest support for new initiatives or feasibility projects for either new investigators or for established mid-level investigators who are moving into research areas of direct interest to the EHS Core Centers. Up to 25% of the annual budget can be allocated to the pilot projects program.

Section IV. Application and Submission Information

1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

To assist in preparing the application, Table A: Grant Support; Table B: Center Members; Table C: Facility Core Use, which have been preformatted to facilitate completion, are provided and can be downloaded from the NIEHS website at http://www.niehs.nih.gov/research/supported/centers/core/guidelines.cfm and inserted into the application.

Competing continuation (renewal) applications will also find Table D1: Publications Resulting from Center Involvement; Table D2: Publications Resulting from Pilot Project Funding, Table E1: Pilot Projects and Outcomes; and Table E2: Grant Details for Funded Pilot Projects that are provided for their convenience at http://www.niehs.nih.gov/research/supported/centers/core/guidelines.cfm.

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: February 28, 2009
Application Receipt Date: March 27, 2009
Peer Review Date: July 2009
Council Review Date: January 2010
Earliest Anticipated Start Date: April 1, 2010

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Linda Bass, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 530, Room 3074
P.O. Box 12233, K3-03
530 Davis Drive
Research Triangle Park, NC 27713
Telephone: (919) 541-1307
FAX: (919) 541-2503
Email: [email protected]

3.B. Sending an Application to the NIH

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

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

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

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

Linda Bass, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 530, Room 3074
P.O. Box 12233, K3-03
530 Davis Drive
Research Triangle Park, NC 27713
Telephone: (919) 541-1307
FAX: (919) 541-2503
Email: [email protected]

3.C. Application Processing

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

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or renewal award if such costs: 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 renewal award.

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

6. Other Submission Requirements and Information

Research Plan Page Limitations

Applicants should use the following guidance, in addition to the instructions accompanying the PHS 398 form.

PAGE LIMITS

1. Strategic Vision and Impact on Environmental Health 25 pages

2. Environmental Health Identity and Impact of Research Base 25 pages

3. Center Director - 5 pages

4. Career Development 10 pages

5. Institutional Commitment 5 pages

6. Administrative Core 25 pages

7. Each Facility Core 25 pages

8. Pilot Projects 25 pages

9. COEC (optional) 25 pages

Template Tables and appendix material do not count towards the page totals.

ALLOWABLE BUDGET ITEMS

New or first-time applicants can apply for up to four years of support. New applications are limited to requests for no more than $500,000 in direct costs in the first year; $600,000 in direct costs in the second year; $700,000 in direct costs in the third year; and $800,000 in direct costs in the fourth year. An additional $100,000 in direct costs in each year may be requested if a COEC is to be included. Competing renewal applications may request up to five years of support and up to $1,000,000 per year direct costs. The application may request up to $1,100,000 per year if it includes a COEC, with a minimum of $100,000 devoted to that core.

To aid in review of the application, it is recommended that separate budget pages be prepared for each of the following elements. For expanded details on allowable and non-allowable budget items, please see http://www.niehs.nih.gov/research/supported/centers/core/guidelines.cfm

1. Administrative Core

2. Each Facility Core

3. Pilot Projects

4. Optional COEC

A. Personnel Salaries

Salaries are permitted only for the following:

1. Senior Leadership including the Director, Deputy Director, and Facility Core Leaders.

2. Core Center Leaders including designated directors or coordinators of the identified Facility and Research Cores of the application. For each Facility Core or Research Core, a single Leader or Director must be identified.

Salaries for Co-Directors, consultants, or other investigators within a Facility or Research Core are not permitted without significant, extraordinary justification. If present, terms such as Co-investigators, etc must be clearly defined and the role of individuals identified as such require clear justification in order to qualify for salary support. This aspect of the application will be considered by the reviewers as will the proposed level of effort for the stated role.

3. Recruited Center Investigators, Named New Investigators

4. Administrative and Technical Support Personnel.

5. Trainees and Career Research Support: Allowable costs for Career Development Activities in Clinical Research include salary support for the Core Leader and other participating senior investigators and staff, travel costs for new investigators, and costs for courses, seminars, workshops, and other activities directly related to the development plan.

Approval from NIEHS will be required for salaries beyond the senior leadership or other individuals specifically described in this section.

B. Equipment/Facilities

This category includes items for broad use in the Center within a Facility Core. Center grant funding is particularly useful for purchases and operations of large items of equipment which are difficult to justify in individual grant applications. When equipment is requested, similar items already available must be reported and a clear justification of the function for the new ones must be provided. The application should provide a list of potential users and projects, giving grant numbers, if possible. The applicant must also provide, on the budget justification page, any duplicate requests which have been made for funding the equipment requested.

C. Supplies

Consumable supplies, such as office materials, glassware, animals, chemicals, etc. may be requested, provided they are items used in common by Center personnel and serve to reduce the cost requirements for individual projects. The requested budget for supplies should be in the appropriate Administrative, Facility, or COEC Core providing this service.

D. Travel

Appropriate travel requests include:

1. Annual Centers Meeting: A two day annual meeting of the EHS Core Centers Program will be held at a location determined by the Center Directors in consultation with NIEHS Staff. Applicants must budget travel costs associated with the meeting for the Center Director and Deputy Director in their application. Funds may also be allocated for trainees such as the Named New Investigator to attend the annual meeting.

2. Travel of the Center Director, one other Center scientist, and an administrator to meetings with other EHS Center Directors or to other center facilities pursuant to administration of the Center.

3. Travel of scientific, technical, or administrative staff for training that would enhance the quality or is required to maintain the operation of a Facility Core or COEC operation.

4. Travel of Named New Investigators and Newly Recruited Center Investigators to relevant scientific meetings.

All travel should be budgeted within the appropriate core unit.

E. Consultants

Travel and expenses for consultants and members of the External Advisory Committee and their associated costs may be included. Support of consultants must be fully justified in terms of program needs.

F. Pilot Projects

Pilot projects are required and up to 25% of the direct costs of each year's budget may be allocated to their support.

Competitive and non-competitive renewal applications should clearly delineate and report the specific allocations of grant funds to the pilot projects program for each year of funding, providing details as described earlier.

G. Other Expenses

Maintenance contracts on general use equipment, duplication costs for annual reports, computer rentals, etc., may be included if fully justified by the application. Requests for funds for equipment maintenance must specify what items are to be maintained, the total yearly cost for maintaining each item, the main users of the item, any other source requesting funding for maintenance of these items, and the amount being contributed from other sources. Publication costs and page charges related to research results of pilot projects are allowed. However, publication costs and page charges for dissemination of other research results by staff investigators are not allowable. Costs of developing, printing, and distributing educational materials are permissible to the extent authorized by PHS policy. Inclusion of a statement recognizing that the document was created in whole or in part with NIEHS/NIH funds should be included on publications. The requested budget for these expenses should be in the appropriate Administrative, Facility, or COEC Core providing this service.

H. Alterations and Renovations

Funds for alteration and renovation of existing facilities may be requested so long as required for operation of Center programs. However, NIEHS Staff should be consulted as early as possible in the planning of these facilities for special instructions, limitations, etc. Funds for alterations and renovation will not be allowed unless there will be at least two years remaining on the grant at completion of the proposed alterations and renovations.

I. Contracts and Consortium Arrangements

These require special budgetary and reporting formats. The NIEHS staff should be consulted prior to submission for special instructions.

Items Not Fundable Under a P30 EHS Core Center Grant Include:

A. Direct support of individual research projects.

B. Salary and support for central institutional administrative personnel, usually paid from institutional overhead charges.

C. Salary and support for administrative activities such as public relations.

D. Travel of investigators, other than Recruited Investigators and Named New Investigators to scientific meetings.

E. Page and publication charges for staff investigators.

Appendix Materials

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

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

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their NIH program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

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

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

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 NIEHS 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 following will be considered in making funding decisions:

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

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

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

Significance. Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s). Are the PD/PIs, collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the Center Director have the ability to provide scientific and administrative leadership and direction? Does the application indicate that the Center Director has the authority to appoint new members to the Center and discontinuing membership status, when appropriate? Is the Deputy Director qualified to serve in the absence of the Director?

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?

Strategic Vision and Impact on Environmental Health: Are the plans for the current and future direction of the Center clear and appropriate? How will the research supported by the Center impact our understanding of environmental health sciences and, ultimately, public health? Are the Center’s plans sufficient to promote multi-disciplinary studies and collaborations, especially among basic scientists and clinical researchers? Are the Center’s plans targeted towards building research capacity? Will the plans, as proposed, bring investigators into the Center from within and outside environmental health sciences?

For renewal applications, the following additional criteria will be included: What were the Center’s accomplishments in the preceding project period and how did they build upon its successes? Has the Center been successful in the translation of basic science advances to the bedside or to public health and are their plans for enhancing the transition in the next project period adequate?

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? Does the Center have the skills, technologies, and capacity to foster interdisciplinary, state-of-the-art, and innovative research that would lead to results in important discoveries or major scientific advances in the chosen areas of scientific focus? Are the size and breadth of the research grant base in the Center directly relevant to environmental health sciences and to the theme of the Center, placing special emphasis on NIEHS-supported grants? Does the Center take advantage of the capability of its research base to maximize scientific productivity, particularly through interdisciplinary coordination and collaboration?

For renewal applications, the following additional criteria will be included. Has the Center made major progress and achievements since its last competitive renewal? Explain these accomplishments. Have there been any changes in the environmental health sciences research orientation of the Center? If yes, what are the impacts of these changes on the Center since the last review?

What specific resources provided to the Center by the institution, such as personnel, appropriate facilities, financial support, and other forms of support will assure the success of the Center?

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

Institutional Commitment: There must be a strong institutional commitment to the Center. The following review criteria will be included:

For renewal applications, the following additional criteria will be included.

Performance and Productivity:

Career Development for Environmental Health Investigators:

For competing continuation applications, the following additional criteria will be included.

Administrative Core:

The Administrative Core will be assessed based on the following criteria:

For competing continuation applications, the following additional criteria will be included.

Facility/Service Cores:

The Facility/Service Cores will be assessed based on the following criteria:

Integrative Health Sciences Facility Core:

The Integrative Medicine Facility Core will be assessed based on the following criteria:

Pilot Project Program:

The Pilot Project Program will be assessed based on the following criteria:

For new applications, the following additional criteria will be included.

For competing continuation applications, the following additional criteria will be included.

Community Outreach and Education Core (COEC) (optional):

The COEC will be assessed based on the following criteria:

For competing continuation applications, the following additional criteria will be included.

NIH considers the following in evaluating Center grant applications:

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.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewal Applications. When reviewing a Renewal application (formerly called a competing continuation application), the committee will consider the progress made in the last funding period.

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

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

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

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

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

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

3. Anticipated Announcement and Award Dates

Not Applicable

Section VI. Award Administration Information

1. Award Notices

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

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

3. Reporting

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

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

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Leslie Reinlib, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 530, Room 3072
P.O. Box 12233 (K3-12)
530 Davis Drive
Research Triangle Park, NC 27713
Telephone: (919) 541-4998
Fax: (919) 316-4606
E-mail: [email protected]

2. Peer Review Contacts:

Linda Bass, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 530, Room 3074
P.O. Box 12233 (K3-03)
530 Davis Drive
Research Triangle Park, NC 27713
Telephone: (919) 541-1307
FAX: (919) 541-2503
Email: [email protected]

3. Financial or Grants Management Contacts:

Aaron Nicholas
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 530, Room 3053
P.O. Box 12233 (K3-11)
530 Davis Drive
Research Triangle Park, NC 27713
Telephone: (919) 541-0039
Fax: (919) 541-2860
E-mail: [email protected]

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/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. 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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