Part I Overview Information


Department of Health and Human Services

Participating Organizations          
National Institutes of Health (NIH) (http://www.nih.gov)
U.S. Environmental Protection Agency (EPA) (http://www.epa.gov/)

Components of Participating Organizations
National Institute of Environmental Health Sciences (NIEHS) (http://www.niehs.nih.gov)
National Center for Environmental Research (NCER) (http://www.epa.gov/ncer)

Title: Children’s Environmental Health and Disease Prevention Research Centers (P01)

Announcement Type
This is a reissue of RFA-ES-05-004.  

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

Request For Applications (RFA) Number: RFA-ES-08-002

Catalog of Federal Domestic Assistance Number(s)
93.113, 66.509

Key Dates
Release Date:  January 21, 2009
Letters of Intent Receipt Date:  March 30, 2009
Application Receipt Date: April 30, 2009
Peer Review Date: June 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 1, 2009
Additional Information To Be Available Date (Url Activation Date):  Not Applicable
Expiration Date: May 01, 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

Background

Ten years ago, NIEHS and US EPA concurrently funded a program called the Centers for Children’s Environmental Health and Disease Prevention Research, also commonly referred to as the Children’s Environmental Health Centers (CEHCs) http://www.niehs.nih.gov/research/supported/centers/prevention/index.cfm, and http://es.epa.gov/ncer/childrenscenters/. The CEHCs have been examining the interaction between environmental exposures and child health outcomes. Combining research and outreach, these Centers form a national network to address a range of health outcomes that may result from environmental exposures, including impairments in overall growth and development, nervous system development and respiratory dysfunction. The Centers work with communities, health care providers, researchers and government officials to conduct research with the goal to prevent and reduce childhood diseases in these areas.

The current structure of the CEHCs has evolved over the past 10 years to emphasize an interdisciplinary approach that includes basic, applied, and community-based participatory research.  The Centers are required to translate and apply their research findings into information for the public, policymakers and clinical professionals with the ultimate goal of protecting the health of children.

Scientific Knowledge To Be Achieved:

NIEHS and US EPA will continue to support and facilitate clinical, basic laboratory, and public health science to:  (1) identify the influences of environmental exposures on normal physiological function of organs and systems of the fetus/child during gestation and/or early childhood; (2) determine the mechanisms of vulnerability to environmental stressors of the developing fetus and young child at all stages of early development; and (3) understand the impact of the complex environment on children’s health including chemicals, diet and nutrition, physical activity and psychosocial factors, from birth through young adulthood.  Nutrition, social and cultural factors cannot be considered alone, but they can be included as secondary or modifier variables to the primary environmental stressor. 

Research Objectives, Results and Outcomes

NIEHS and US EPA have developed a joint program with multiple opportunities to enhance the research in children’s environmental health to meet each agency’s mission as well as fill the identified research gaps.  This Funding Opportunity is one of two simultaneous efforts of the joint program that will serve to create the next phase of the Children’s Environmental Health and Disease Prevention Research Centers (CEHCs).  This FOA (P01) is characterized by strong multidisciplinary research with multiple projects and a well-developed program of cutting-edge research.  A companion announcement, “Children’s Environmental Health and Disease Prevention Centers: Formative Centers” (P20) may be found at RFA-ES-08-004.  The purpose of the CEHC Formative Centers is to foster and stimulate new research ideas in children’s environmental health that are in the early phase of scientific inquiry and where the preliminary data or support or partnerships may be limited. 

NIEHS and EPA support a flexible and integrated multi-project approach to create the next generation of CEHCs (P01).   The objectives are to (1) capitalize on the research findings and resources from ongoing epidemiology and clinical studies of pregnant women and children; (2) enhance the dynamic application of novel findings and approaches in areas of basic or mechanistic research e.g., imaging, epigenetics and comparative biology to human studies; (3) develop and apply new or improved biomarkers to best characterize exposure effects on human biology and to predict long-term clinical consequences; (4) train new investigators who can address emerging issues in children’s environmental health with state of the art tools and methodologies; and (5) ensure active participation of the identified stakeholders in the research process and translation of research findings. 

NIEHS and EPA expect a variety of possible results and outcomes may result from this joint program including but not limited to the following:

Research Approaches

The types of research approaches that are encouraged to be submitted under this FOA include but are not limited to the following:

Research Topics of interest that applications may focus on under this FOA include, but are not limited to those listed below:

Required Components

Each Center will propose an overall scientific research theme and plan related to the role of the environment in the etiology, prevention or treatment of children’s health endpoints and that is responsive to the objectives of the NIEHS and EPA Children’s Centers Program. 

The application must contain a minimum of three (3) unique but integrated research projects related to the Center’s theme and three (3) essential elements:

Each Center must also include an Administrative Core to provide oversight, coordination and integration of Center activities.  Applications not containing at least three projects, the three essential elements and an Administrative Core will be considered non-responsive and not be  reviewed.

A Community Outreach and Translation Core (COTC) is optional. 

Detailed Description of Required Components in the Application

Each Center must propose an overall research theme and plan that is responsive to the objectives of the NIEHS and EPA Children’s Centers Program.  The application must contain three (3) essential elements (outlined below), a minimum of three (3) research projects and an Administrative Core.

A.  Each Center should be developed around a central scientific theme related to the role of the environment in the etiology, prevention or treatment of children’s health endpoints.  Each application will require three unique but integrated research projects (equivalent to an R01) related to the Center’s theme.  Research projects should be designed to answer important research questions identified as part of the research theme.  The research team can balance the scientific disciplines and approaches in any way to answer the questions posed by the Center.  Some approaches that are relevant to the field of children’s environmental health include but are not limited to:

·         Basic scientific discovery and mechanistic research using in vitro laboratory research in molecular and cellular models

·         Translation from animal models to clinical investigation

The inclusion of clinical studies with humans or human biospecimens is encouraged, but not required. For example, a Center consisting of three basic science projects may be appropriate if there is a compelling rationale for the relevance of the information to be gained to children’s environmental health but the direct translation to clinical science is premature or not immediately feasible. In that case, the application should provide a clear plan for how the research findings emerging from the basic science projects will move the field towards translation into human studies by the end of the five-year period.

B.  To accomplish the research objectives of the program, the Centers will be required to incorporate several essential elements into the proposed program.  These essential elements include: 

(1) Community engagement (CE).  Each Center must demonstrate meaningful and active participation of relevant stakeholders that may have concerns about children’s environmental health and/or the environmental exposures under investigation.  Applicants are encouraged to consider a variety of mechanisms for community engagement, including, but not limited to: formation of community advisory boards, inclusion of a Community Outreach and Translation Core (COTC), or use of a community-based participatory research (CBPR) approach for one or more of the projects. Evidence of a productive working relationship between the community and Center researchers is a necessary component of each Center.  This active engagement should be described fully in the Administrative Core portion of the application.  Responsiveness to this criterion will need to be apparent to the administrative reviewers to judge responsiveness as well as to the peer-reviewers, so the applicant must clearly define the approach the Center will take to incorporate Community Engagement in Section II of the P01 application.   

(2) Pediatric Health Specialist.  Each Center must have at least one clinical expert who is an active researcher, who is qualified to assist with coordination and integration of the scientific projects, and who will help ensure that the science under investigation will translate to clinical practice or have a positive impact on public health. This person may come from any discipline that traditionally has direct contact with young children in a treatment-based environment; however, the expertise should be suited to the Center’s scientific theme.  This individual should be distinct from the Center PI. This function can be supported as part of the Administrative Core at no less than 10% effort.  The pediatric health specialist may serve as a project leader or co-leader or co-investigator with additional percent effort.

(3) Career Development.  In order to foster the next generation of creative new scientists in children’s environmental health, Center PI’s are required to support the research career development of new, junior faculty-level investigators within the structure of the Children’s Center.  One individual should be designated for Faculty Development in the application.  This person will be expected to devote a minimum of 30% time and effort to the award and have a long-term commitment to research in the environmental health sciences.  The Faculty Development Investigator (FDI) may hold either a health professional doctorate (M.D., D.O, Pharm. D., doctoral degree in nursing, or other equivalent degree) or a research doctoral degree (Ph.D., or equivalent), should have fewer than eight years of postdoctoral experience (excluding clinical training years) at the time the application is submitted, and should have demonstrated outstanding abilities in basic, clinical or population based research.   Designated Faculty Development Investigators must meet the NIH definition of New Investigator, http://grants.nih.gov/grants/new_investigators/resources.htm#definition.  The PI must include a description of the career development proposed to be undertaken by the Faculty Development Investigator and provide a letter of recommendation for the designee.  A letter from the FDI candidate outlining his/her career goals should also be included in the application. The Faculty Development plan should be included as part of the Administrative Core   If the candidate is unknown at time of application of submission, a general plan to recruit the FDI is required. 

C. Core(s):

1.  Administrative Core (required): Each Center must include an Administrative Core unit to provide oversight, coordination, and integration of Center activities.  An External Advisory Committee (EAC) to the Center Director should be established and be managed as part of the Administrative Core.  The function of the EAC is to assist in evaluating the merit, value and ongoing progress of each research project and the relevance and importance of individual organizational elements to accomplish the overall goals of the Center.  This group should consist of a group of three to five members having expertise appropriate for the Center's research focus, plus one representative from a community group.  Representation from a state or local health department is also encouraged.  At least two-thirds (67 percent) of the Committee members should be from outside the grantee institution.  The function of this Committee is to assist in evaluating the merit, value, and contribution of research projects; the relevance and importance of individual organizational elements to accomplishing the overall goals of the Center. The membership of the advisory committee must be approved by the Participating Agencies post review.  The EAC is required to meet at least once annually and NIEHS and EPA staff should be notified of the meeting and invited to attend. A brief report describing the recommendations of the EAC should be provided as part of the annual progress report. Names of potential EAC members should not be solicited or submitted in the application.  Individuals in senior leadership positions should provide intellectual, administrative, and scientific leadership for the Center and are critical to its overall effectiveness and evolution.  These individuals should be in place and committed to a defined percent effort.  Please only submit a description of proposed protocols and planned committee by representation and area of expertise.  If awarded, you will be asked to provide an identifiable list of membership to the EAC for approval by the funding agencies.  Unless otherwise performed by the COTC (optional), the Administrative Core should coordinate community engagement and facilitate meaningful exchange between Center investigators and the community of stakeholders.  Unless otherwise performed by the COTC (optional), the Administrative Core should coordinate community engagement and facilitate meaningful exchange between Center investigators and the community of stakeholders.

2. Community Outreach and Translation Core (COTC) (optional). , The purpose of this Core is to develop, demonstrate and evaluate strategies to translate and apply the scientific findings of the Center into information for the public, policymakers, and clinical professionals to use to protect the health of children.  This must include personnel from one or more of the following areas:  health educators, nurses, members of community or faith-based organizations, members of organizations which advocate for research and services pertaining to children's health, members of professional societies of health care professionals, and state and local health departments or medical service organizations. Examples of activities considered responsive are the creation of training materials for health professions, development of novel strategies for dissemination of research findings to the broad audience of stakeholders, and assessment of community understanding of research results and plans for action.  The Center PI may request up to $100,000 in direct costs to support a COTC within the Center Program.

3.  Other Cores (as needed): Each Center may support other cores that provide a technique, service, or instrumentation that will enhance ongoing research efforts.  Each core facility must serve at least two research projects.  Examples include animal resources, cell/tissue culture, pathology, biostatistics, molecular biology, neuropsychology, neuroimaging, analytical chemistry, exposure assessment, genotyping and resequencing.

Applicants must study an environmental agent/chemical/stressor to which there is human exposure and the potential for an in utero or childhood exposures.  This includes any endocrine active chemical(s) or organic solvents, particulate matter (PM), pesticides, phytochemicals or metals.  Nutrition, social and cultural factors cannot be considered alone, but applicants are encouraged to include them as secondary or modifier variables to the primary environmental stressor. 

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the NIH P01 award mechanism.

The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project

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

2. Funds Available

EPA and NIEHS plan to concurrently fund Centers with funding shared by EPA and NIEHS and managed by both EPA and NIEHS.  If a Center is concurrently funded, the Center will be supported by two awards: one which provides the EPA portion of the budget, and a companion award which provides the NIEHS portion of the budget.  There may be an opportunity for a Center to be funded by only one agency related to mission priorities or program needs, in which case the Center will receive one award by the funding agency. 

NIEHS and EPA intend to only award grants under this FOA.

In appropriate circumstances, EPA and NIEHS reserve the right to partially fund proposals/applications by funding discrete portions or phases of proposed projects. If EPA and NIEHS decide to partially fund a proposal/application, they will do so in a manner that does not prejudice any applicants or affect the basis upon which the proposal/application, or portion thereof, was evaluated and selected for award, and therefore maintains the integrity of the competition and selection process.

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 NIEHS and EPA 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 limitations; 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:

Nonprofit organizations described in Section 501(c) (4) of the Internal Revenue Code that lobby are not eligible to apply.  Profit-making firms are also not eligible to receive grants under this program.

National laboratories funded by Federal Agencies (Federally-Funded Research and Development Centers, “FFRDCs”) may not apply.  FFRDC employees may cooperate or collaborate with eligible applicants within the limits imposed by applicable legislation and regulations.  They may participate in planning, conducting, and analyzing the research directed by the applicant, but may not direct projects on behalf of the applicant organization.  The institution, organization, or governance receiving the award may provide funds through its assistance agreement from the EPA to an FFRDC for research personnel, supplies, equipment, and other expenses directly related to the research.  However, salaries for permanent FFRDC employees may not be provided through this mechanism.

Federal Agencies may not apply.  Federal employees are not eligible to serve in a principal leadership role on an assistance agreement, and may not receive salaries or augment their Agency’s appropriations in other ways through awards made under this program.

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.

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

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

Renewals. Renewal applications are permitted in response to this FOA.

Number of Applications. Applicants may submit more than one application, provided each application is scientifically distinct.

Each Center will propose an overall scientific research theme and plan related to the role of the environment in the etiology, prevention or treatment of children’s health endpoints and that is responsive to the objectives of the NIEHS and EPA Children’s Centers Program. 

The application must contain a minimum of three (3) unique but integrated research projects related to the Center’s theme and three (3) essential elements:

Each Center must also include an Administrative Core to provide oversight, coordination and integration of Center activities.  Applications not containing at least three projects, the three essential elements and an Administrative Core will be considered non-responsive and returned without review.

The Principal Investigator (also referred to as Program Director) of the Children’s Environmental Health and Disease Prevention Center will be required to commit a minimum of 20% effort to the Center.

Studies involving intentional exposure of human subjects who are children or pregnant or nursing women are prohibited by Subpart B of 40 CFR Section 26.  For observational studies involving children or pregnant women and fetuses please refer to Subparts C & D of 40 CFR Section 26. 

Applicants must study an environmental agent/chemical/stressor to which there is human exposure and the potential for an in utero or childhood exposure.  This includes any endocrine active chemical(s) or organic solvents, particulate matter (PM), pesticides, phytochemicals or metals.  Nutrition, social and cultural factors cannot be considered alone, but applicants are encouraged to include them as secondary or modifier variables to the primary environmental stressor.

In addition, to be eligible for EPA funding consideration, a project’s focus must consist of activities within the statutory terms of EPA’s financial assistance authorities; specifically, the statute(s) listed in Section VIII. Other Information Required Federal Citations “Authorities and Regulations”.

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

Guidance for Applicants Submitting a P01 Children’s Environmental Health Grant

Applicants should use the following guidance, in addition to the instructions accompanying the PHS 398 form.  The Children’s Environmental Health Center grant proposal must consist of five general sections of information:

Section I.  This section includes PHS 398 Form Pages 1-3, PHS 398 Form Page 4 - Detailed Composite Budget for the First 12-month Period Description and Form Page 5 – Composite Budget for All Years, All Projects as well as the corresponding budgets for each individual project and core supported by the CEHC application.  In addition, a table that indicates the percentage use of each facility core relative to the individual projects should be included to assist the reviewers in determining the relationship between Facility Cores and Research Projects. Biographical Sketches should be provided for all KEY investigators using the PHS 398 Biographical Sketch Format Page.  List the Center Director first followed by all other key personnel in alphabetical order.  Use duplicate copies of the Biographical Sketch Format page for each investigator. Include only one copy of each biosketch in the application.  Lastly, Section I should include Institutional Environment and Resources using the PHS 398 Resources Format Page.  Include a brief description of the environment where the overall program and other activities will be conducted. If more than one campus or location will be involved, briefly describe each setting. If unique resources are available, briefly describe these and their relevance to the proposed program.

Section II.  This section is unique to the P01 application.  The information covered in this section for the most part, is not covered in the PHS 398.  The page limit for this section is 15 pages. This section includes:

Program Introduction and Statement of Objectives

Describe the major theme of the Center, its goals and objectives, background information and the overall importance of the research to the missions of NIEHS and EPA.  This should include the children’s disease(s) and primary environmental stressors of study and the overall hypotheses to be tested.  The applicant must provide a compelling rationale for the environmental significance of the children’s disease(s) of interest. The program should be viewed as a group of interrelated research projects, each of which is individually scientifically meritorious but is also complementary to the other projects, and related to the overall theme developed for the Center.

Describe the rationale for the total proposed program.  Explain the strategy for achieving the expected results and outcomes defined for the overall program and how each research project and core relates to that strategy.  Highlight how the findings of the research efforts will impact clinical and public health practice and how the CEHC will facilitate this translation.

Indicate and describe any collaborative arrangements between investigators in the group and the anticipated unique advantages that would be gained by the interdisciplinary approach proposed for the research being conducted. 

Explain how different components of the organization, including key personnel, will interact, why they are essential to accomplishing the overall goal of the research, and how combined resources create capabilities that are more than the sum of the parts.  Very clear evidence that the key personnel will collaborate effectively must be presented in the application.

Describe briefly a summary of how the program will incorporate the essential elements of the Children’s Environmental Health and Disease Prevention Centers program including the approach for Community Engagement, the Pediatric Health Specialist, and Career Development.  

Organizational and Administrative Structure

Describe in detail and by diagram the organizational structure of the program including an administrative and management plan that achieve an integrated, coordinated interdisciplinary research program. 

In broad terms describe how the administrative core supports the goals and organization of the program.  Include a discussion of the function of advisory groups (both internal and external) used in the capacity of advisors and overseers of quality control.  Identify the expertise needed but do not identify by name the external consultants serving on advisory groups. Be aware that the external advisory committee must meet at least once a year and must present a written report to the NIEHS program staff two months prior to the end of the fiscal year in order to ascertain progress to secure the next year’s funding.

Describe the role of the Director and the investigators responsible for the direction of the research projects and core units. The Director of the overall CEHC is called the Principal Investigator; the leaders of the individual projects are referred to as Project Leaders.  Indicate where, in the chain of responsibility, advisory groups (internal and external consultants) would be used.

Describe how the CEHC will be used to advance cross-disciplinary training in environmental health sciences and children’s research.  Include a description of the existing training resources and activities available through the applicant institution and the potential pool of trainees, with clear delineation of how the Center will enrich/augment these existing resources.

Indicate how the Center’s progress towards expected scientific and training outcomes will be monitored and adjusted as needed. 

Describe the relationships between the proposed Center and other existing research, academic, and administrative units of the applicant institution such as schools, centers, institutions, departments, and central administration.

Sections III-V.  These sections contain the research plans of the individual research projects, facility cores, and administrative core.

General Instructions for All Projects and Cores:

All Projects and Cores

For the title page of individual projects/cores use the PHS 398 Continuation Page and clearly denote the project/core number, the title of the project/core, and the project/core leader.  The title must not exceed 56 characters/spaces.  DO NOT provide a face page (i.e., PHS 398 Form Page 1) for individual projects.

The "Description" of the project/core should be prepared on a duplicate copy of PHS 398 Form Page 2.  All performance sites and key personnel on the project/core should be identified.

The name of the Principal Investigator of the CEHC grant application is placed in the upper right corner of each page, not the name of the Project/Core Leader.  Also note: individual projects and cores must not exceed the 25-page limitation for items 2-5 of the Research Plan (follow PHS 398 instructions).

Subsequent pages (following the Description, Performance, and Key Personnel, Form Page 2) should use Continuation Pages and follow PHS 398 Instructions.  If collaborative or consortium arrangements are included in the application, follow PHS 398 Instructions.  Discussion should be included as to how the collaborative arrangements will be of value in achieving the specific objectives of the project.

The following information should NOT be included in the individual projects or cores. They should be included only in Section I of the application. "Face Page"(Form Page 1); "Research Grants Table of Contents" (Form Page 3); "Detailed Budget for Initial Cost Period" (Form Page 4); "Budget for Entire Proposed Period of Support" (Form Page 5); "Biographical Sketch Format Page"

Include “Letters of Commitment” and collaborative arrangements/consultants (Research Plan) that are identified in the application.

Include "Resources Format Page" within the individual Research Projects and Core sections. Include this at the end of the Research Plan.

Applicants should carefully read and adhere to the PHS 398 instructions concerning children, gender and minority inclusion in human study populations.

Section III – Individual Research Projects

Follow the instructions in the PHS 398 for the Research Plan for describing each research project.  Note that items 2-5 of the Research Plan may not exceed 25 pages (per project), including all tables and figures.

Each project should clearly state its overall objective and explain its relevance to the central theme of the CEHC program.  In addition, an explanation should be included describing how the project relates to and both complements and enhances the other research projects and cores of the program.

The instructions in the PHS 398 form should be used to complete items 6-17 for the individual research projects.

Section IV – Facility Cores

Follow the instructions in the PHS 398 Research Plan (1-17) as is appropriate for describing a Facility Core.  A Facility Core is defined as a resource for the CEHC that provides centralized services to two or more research projects.  Information that should be included is as follows:

Describe the function of the core as a resource to the program. This section must clearly present the facilities, techniques, and professional skills that the core will provide.  As justification for the core, briefly indicate the specific Research Projects that will use the resources of the core.  A Research Support Core is principally designed as a service or resource component; it would be highly unusual to include research in a core (a possible exception would be methodology development).  Please contact the NIEHS program staff if you require guidance on this issue.

Describe the role of the core as a resource to the program as a whole. Discuss ways in which these centralized services will produce an economy of effort and/or savings in overall costs compared to their inclusion as part of each project in the program.  To aid in the review of your application it is recommended that you prepare in tabular form information concerning the research projects that each facility core unit would serve and the proportion of the cost of the facility core unit associated with each research project involved.

NOTE:  An Applicant is not required to include facility cores in their CEHC. 

Section V – Administrative Core

Follow the instructions in the PHS 398 “Research Plan” (1-17) as is appropriate for describing the Administrative Core.

A successful CEHC application will include a well-integrated project plan.  Within the Administrative Core, the specific administrative and organizational structure that is needed to support the research and the synergies enabled by the Center needed to be clearly articulated. CEHC projects will be multidisciplinary and interdisciplinary and will draw from a variety of resources.  Thus, a well thought out and carefully described organizational structure will be required.

A narrative description should be provided that includes the planning and coordination of research activities; the integration of cross-disciplinary research; the tracking of progress towards Center outputs and outcomes,  the oversight of fiscal and resource management; and the maintenance of ongoing communication with NIEHS and EPA.  Indicate who will be responsible for each of these activities.  Describe the role(s) of advisory groups and consultants.

Describe how the Administrative Core will coordinate the research activities with existing training resources, activities or programs at the institution.  No specific funds should be used to develop new training programs or to directly support existing training programs, however, a listing of available training resources should be provided.  A plan for tracking the impact of CEHC on investigator training should be described.

Describe how the Administrative Core will coordinate meetings of CEHC investigators with investigators from other CEHCs. 

The applicant should budget travel funds sufficient for attendance of the Center Director and Project and Core leaders at an annual meeting, a one and one-half day meeting at the NIEHS in Research Triangle Park, NC or at the US EPA in Research Triangle Park, NC or Washington DC.

Describe the Pediatric Health Specialist and their expertise and role in the overall integration of the proposed projects and the support of the overall translation central theme of the Center.

Section VI – Community Outreach and Translation Core (optional)

A successful COTC should describe a plan to collect, integrate and disseminate research findings and Centers activities for the public, policy makers, and clinical professionals to use to protect the health of children. 

Describe the membership of the COTC and types of expertise to be recruited to enhance effective communication strategies. Describe the type of innovative methods that may be used to enhance COTC activities including ways of interacting with stakeholders or identified end-users of materials.

Describe plans of how the COTC investigators will be able to access the effectiveness of their developed products and whenever possible. 

Describe how the COTC will interact with Center investigators and the Administrative Core to develop materials and assist with the goals of the COTC.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letter of Intent Receipt Date: March 30, 2009
Application Receipt Date: April 30, 2009
Peer Review Date: June 2009
Council Review Date: August 2009
Earliest Anticipated Start Date: September 1, 2009

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIEHS and EPA 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.
Division of Extramural Training and Science
National Institute of Environmental Health Sciences
PO Box 12233, EC-30
111 T.W. Alexander Drive
Research Triangle Park, NC, 27709
Telephone: (919) 541-1307
FAX: (919) 541-2503
Email: bass@niehs.nih.gov

3.B. Sending an Application to the NIH

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

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

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

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

Linda Bass, Ph.D.
Division of Extramural Training and Science
National Institute of Environmental Health Sciences
PO Box 12233, EC-30
111 T.W. Alexander Drive
Research Triangle Park, NC, 27709
Telephone: (919) 541-1307
FAX: (919) 541-2503
Email: bass@niehs.nih.gov

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review, except for the following issue as stated by EPA below.

EPA Supplemental Information:

Executive Order 12372, “Intergovernmental Review of Federal Programs,” does not apply to the EPA Office of Research and Development's research and training programs unless EPA has determined that the activities that will be carried out under the applicants' proposal (a) require an Environmental Impact Statement (EIS), or (b) do not require an EIS but will be newly initiated at a particular site and require unusual measures to limit the possibility of adverse exposure or hazard to the general public, or (c) have a unique geographic focus and are directly relevant to the governmental responsibilities of a State or local government within that geographic area.

If EPA determines that Executive Order 12372 applies to an applicant's proposal, the applicant must follow the procedures in 40 CFR Part 29.  The applicant must notify their state's single point of contact (SPOC). To determine whether their state participates in this process, and how to comply, applicants should consult http://www.whitehouse.gov/omb/grants/spoc.html.  If an applicant is in a State that does not have a SPOC, or the State has not selected research and development grants for intergovernmental review, the applicant must notify directly affected State, area wide, regional and local entities of its proposal.

EPA will notify the successful applicant(s) if Executive Order 12372 applies to its proposal prior to award.  

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 or EPA 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 prior approval from NIH and EPA. If specific expenditures would otherwise require prior approval from NIH and EPA, the grantee must obtain approval from NIH and EPA before incurring the cost. 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 an award imposes no obligation on NIH or EPA 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.)

EPA Supplemental Information:

All award decisions are subject to the availability of funds.  In accordance with the Federal Grant and Cooperative Agreement Act, 31 U.S.C. 6301 et seq., the primary purpose of an assistance agreement is to accomplish a public purpose of support or stimulation authorized by federal statute, rather than acquisition for the direct benefit or use of a Federal Agency.  In issuing a grant, EPA and NIEHS anticipate that there will be no substantial Agency involvement in the design, implementation, or conduct of the research.  However, EPA and NIEHS will monitor research progress through annual reports provided by grantees and other contacts, including site visits, with the Principal Investigator.

Collaborative applications involving more than one institution must be submitted as a single administrative package from one of the institutions involved.

EPA award funds to one eligible applicant as the recipient even if other eligible applicants are named as partners or co-applicants or members of a coalition or consortium.  The recipient is accountable to EPA for the proper expenditure of funds. IF the grant is funded by both NIEHS and EPA, then the recipient is accountable to EPA and NIEHS for the proper expenditure of funds.

Funding may be used to provide subgrants or subawards of financial assistance, which includes using subawards or subgrants to fund partnerships, provided the recipient complies with applicable requirements for subawards or subgrants including those contained in 40 CFR  Parts 30 or 31, as appropriate.  Applicants must compete contracts for services and products, including consultant contracts, and conduct cost and price analyses to the extent required by the procurement provisions of the regulations at 40 CFR Parts 30 or 31, as appropriate. The regulations also contain limitations on consultant compensation. Applicants are not required to identify subawardees/subgrantees and/or contractors (including consultants) in their proposal/application.  However, if they do, the fact that an applicant selected for award has named a specific subawardee/subgrantee, contractor, or consultant in the proposal/application selected for funding does not relieve the applicant of its obligations to comply with subaward/subgrant and/or competitive procurement requirements as appropriate.  Please note that applicants may not award sole source contracts to consulting, engineering or other firms assisting applicants with the proposal based solely on the firm's role in preparing the proposal/application. 

Please note that when formulating budgets for proposals/applications, applicants must not include management fees or similar charges in excess of the direct costs and indirect costs at the rate approved by the applicants cognizant audit agency, or at the rate provided for by the terms of the agreement negotiated with EPA. The term "management fees or similar charges" refers to expenses added to the direct costs in order to accumulate and reserve funds for ongoing business expenses, unforeseen liabilities, or for other similar costs that are not allowable under EPA assistance agreements. Management fees or similar charges may not be used to improve or expand the project funded under this agreement, except to the extent authorized as a direct cost of carrying out the scope of work.

Successful applicants cannot use subgrants or subawards to avoid requirements in Federal grant regulations for competitive procurement by using these instruments to acquire commercial services or products from for-profit organizations to carry out its assistance agreement.  The nature of the transaction between the recipient and the subawardee or subgrantee must be consistent with the standards for distinguishing between vendor transactions and subrecipient assistance under Subpart B Section .210 of OMB Circular A-133 , and the definitions of subaward at 40 CFR 30.2(ff) or subgrant at 40 CFR 31.3, as applicable.  Neither NIEHS nor EPA will be a party to these transactions.  Applicants acquiring commercial goods or services must comply with the competitive procurement standards in 40 CFR Part 30 or 40 CFR Part 31.36 and cannot use a subaward/subgrant as the funding mechanism.  

EPA will not consider the qualifications, experience, and expertise of named subawardees/subgrantees and/or named contractor(s) during the proposal/application evaluation process unless the applicant complies with these requirements.

Each proposed project must be able to be completed within the project period and with the initial award of funds.  Applicants should request the entire amount of money needed to complete the project.  Recipients should not anticipate additional funding beyond the initial award of funds for a specific project. 

6. Other Submission Requirements and Information

Research Plan Page Limitations

Page Limitations. The page limitations specified for PHS 398 apply to the individual projects of the application. The component relating to the overall project should be as concise as possible. It is not appropriate for additional information such as the research description for individual projects to be included in the overall project description. An application that does not observe the required page limitations may be delayed in the review process.

Introduction Section: For new and renewal applications, the introduction must not exceed 10 pages total.

Research Project: Do not exceed 25 pages for Sections 2-5 of the research plan. This page limitation includes all tables, graphs, figures, and charts.

Core Components: Core components must not exceed 15 pages each.

Appendix Materials

All paper PHS 398 applications 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.

NIH Requirements and/or Expectations

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/.

EPA Confidentiality of Submitted Application

By submitting an application in response to this solicitation, the applicant grants the EPA permission to make limited disclosures of the application to technical reviewers both within and outside the Agencies for the express purpose of assisting the Agencies with evaluating the application.  Information from a pending or unsuccessful application will be kept confidential to the fullest extent allowed under law; information from a successful application may be publicly disclosed to the extent permitted by law.

In accordance with 40 CFR 2.203, applicants may claim all or a portion of the application as confidential business information (for example, hypotheses or methodologies contained in the research narrative that the applicant wishes to protect from possible public disclosure).  EPA will evaluate confidentiality claims in accordance with 40 CFR Part 2.  Applicants must clearly mark applications or portions of applications they claim as confidential.  If no claim of confidentiality is made, EPA is not required to make an inquiry to the applicant as otherwise required by 40 CFR 2.204(c) (2) prior to disclosure.

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 eligible applications will:

The following will be considered in making funding decisions by NIEHS and EPA National Center for Environmental Research (NCER)

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. 

Peer Review Process:

Peer review for scientific and technical merit emphasizes two major aspects of the Children’s Environmental Health Center application:

(1) Individual Center Components

§  Individual Research Projects

§  Administrative Core

§  Facility/Service Core Unit(s),

§  Community Outreach and Translation Core (optional)

(2) Review of the Overall Center

Individual Research Projects

Significance: Does this study address an important problem?  If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project?  Does the applicant acknowledge potential problem areas and consider alternative tactics?  For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

Innovation: Is the project original and innovative?  For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field?  Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?   Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work?  Is the work proposed appropriate to the experience level of the principal investigator and other researchers?  Do the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?

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

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

If the Research Project(s) include(s) Community Based Participatory Research as an aspect of the Project, then the following criteria will be  included in the evaluation. Are the Center’s activities appropriate to the needs of the community involved?  Is the research proposed focused on children’s environmental health or the exposure under investigation? Is there a mechanism present for regular communication and coordination among investigators and relevant stakeholders with concerns focused on children’s environmental health or environmental exposures?  Are the stakeholders involved in other aspects of the Center?  Does a productive working relationship exist between Center investigators and community stakeholders? Will information be adequately disseminated?

Administrative Core

What is the decision-making process within the proposed Center?  Is it adequate for the evaluation of research productivity, allocation of funds, and management of the resources?  Are procedures clearly outlined to measure and track Center goals, outputs and outcomes?

How will the Administrative Core promote joint planning and evaluation activities as well as collaborations and interactions among different Research Projects of the Centers?

What are the academic environment and resources in which the research will be conducted?  Is the there available and appropriate space, equipment, human subjects, animals, or other resources as required for potential interaction with scientist(s) from other departments to complete the scope of work as proposed?

What is the institutional commitment to the Center, including fiscal responsibility and management capability of the institution to assist the Principal Investigator and his/her staff in following DHHS, PHS, NIH and EPA policy?

Career Development. What are the Center’s plans for supporting the research career development of new junior level faculty members?  Does the Center’s plan provide high quality mentoring of junior investigators so as to foster their research careers? Is a mentoring plan proposed, and if so, is the plan adequate?  What are the Center’s plans for monitoring the progression and development of new junior level faculty members?

Pediatric Health Specialist. Is/are the Pediatric Health Specialist(s) appropriately qualified?  Is the Pediatric Health Specialist an active researcher from a discipline that has direct contact with children?

If the community engagement is discussed as a function of the Administrative Core, then the following criteria must be included in the evaluation. Are the Center’s activities appropriate to the needs of the community involved? How will the Center facilitate regular communication and coordination among investigators and relevant stakeholders with concerns focused on children’s environmental health or environmental exposures?  How are the stakeholders involved in other aspects of the Center and how they will interact with Center activities and develop a relationship with the Center Investigators?  If a Community Advisory Board is proposed, does it have appropriate and adequate membership to be successful?

Facility/Service Cores

What is the Core's utility to Center investigators?  Does each Core provide services for two or more research projects that are judged to have substantial merit?

What is the quality of the facility or services provided?

What are the availability and/or adequacy of the physical space, laboratory, clinic and/or equipment proposed for the Core?

What is the cost-effectiveness of the service provided?

Are the qualifications of the personnel involved, their experience, and commitment to the Core appropriate?

Community Outreach and Translation Core (optional)

Are the plans for the establishment of a Community Outreach and Translation Core appropriate and adequate for success?

Have particular community groups or organizations been identified and are their support and commitment adequate and appropriate?

Are the detailed plans and approaches for dissemination from the Core adequate for success?

Overall Center

Does the Center consist of a cohesive and multidisciplinary focus?  Does a coordinated interrelationship exist between the research projects and cores?  Are the components of the Center related to the common theme of the Center?

What is the scientific gain of combining the component parts into a Center?

For new applications, is there evidence of the degree of synergy (degree of interaction, collaborative research opportunities) that will be stimulated by the Center?  How do the research projects and cores relate to the central theme and the ability of the Center to meet its long range goals?

Will the specific scientific objectives of each project benefit significantly from, or depend upon collaborative interactions with other projects in the program (i.e., objectives that can be uniquely accomplished, specific contributions to the accomplishments of objectives in other projects, objectives that can be accomplished with greater effectiveness and/or economy of effort, etc.)?

Have Center investigators adequately addressed the criteria required for each Essential Element (Career Development, the inclusion of a Children’s Health Specialist, and community involvement)?

Have the investigators adequately conceptualized the Center’s expected results and potential benefits to their community of concern or the broader public?

In addition to the above, NIH considers the following in evaluating Center grant applications:

2.A. Additional Review Criteria:

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

Renewal Applications: Is there adequate evidence that the previous specific aims, as funded, have been accomplished and that the new research goals are logical extensions of ongoing work?

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

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

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

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

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research.

EPA Internal Review Criteria for all applications under consideration for EPA support: 

Applications fully discussed and receiving priority scores as a result of the NIEHS peer review will undergo an internal programmatic review, as described below, conducted by technical experts from the EPA, including individuals from the Office of Research and Development (ORD) and program and regional offices involved with the science or engineering proposed.  All other applications are automatically declined.

After the peer review, those applicants receiving priority scores will be asked to provide additional information for the programmatic review pertaining to the proposed Principal Investigator's (PI) "Past Performance and Reporting History."  The applicant must provide the EPA Project Officer with information on the proposed PI's past performance and reporting history under prior Federal agency assistance agreements (assistance agreements include grants and cooperative agreements but not contracts) in terms of: (i) the level of success in performing each agreement, and (ii) how progress towards achieving the results intended under each agreement was reported.  This information is required only for the proposed PI's performance under Federal assistance agreements initiated within the last three years that were similar in size and scope to the proposed project. 

The specific information required for each agreement is shown below, and must be provided within two weeks of EPA's request.  A maximum of three pages will be permitted for the response; excess pages will not be reviewed.  Note: If no prior past performance information and/or reporting history exists, you will be asked to so state.

1.  Name of Granting Agency.

2.  Grant/Cooperative agreement number.

3.  Grant/Cooperative agreement title.

4.  Brief description of the grant/cooperative agreement.

5.  A description of how the agreement is similar in size and scope to the proposed project and whether or not it was successfully performed; if not successfully performed, provide an explanation.

6.  Information relating to the proposed PI's past performance in reporting on progress towards achieving the expected results (outputs/outcomes) under the agreement.  Include the history of submitting timely progress/final technical reports, describe how progress towards achieving the expected results was reported/documented, and if such progress was not being made, provide an explanation of whether, and how, this was reported. 

7.  Total (all years) grant/cooperative agreement dollar value.

8.  Project period.

9.  Technical contact (project officer), telephone number, and E-mail address (if available).

The purpose of the programmatic review is to assure an integrated research portfolio for the Agency and help determine which applications to recommend for award.  In conducting the programmatic review, the EPA will consider information provided by the applicant and may consider information from other sources, including prior and current grantors and agency files.

The EPA internal programmatic review panel will assess:

1.    The relevance of the proposed science to EPA research priorities.

2.  The proposed PI's past performance [under Federal agency assistance agreements (assistance agreements include grants and cooperative agreements but not contracts) initiated within the last three years that were similar in size and scope to the proposed project in two areas:  First, in successfully performing these prior Federal assistance projects, including whether there is a satisfactory explanation for any lack of success.  Second, in reporting progress towards achieving results under these agreements, including the proposed PI's history of submitting timely progress/final technical reports that adequately describe the progress toward achieving the expected results (outputs/outcomes) under the agreements.  Any explanation of why progress towards achieving the results was not made will also be considered.  Applicants whose proposed PI has no relevant past performance and/or reporting history, or for whom this information is not available, will be evaluated neither favorably nor unfavorably on these elements.

2.C. Resource Sharing Plan(s)   

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

EPA and NIEHS will concurrently fund each award under this FOA, thus applicants under consideration for funding may receive 2 (two) separate formal notifications. 

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.

NIH Procedures:  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 Notice of Award 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 Notice of Award 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.

EPA Award Procedures:  Applicants to be recommended for funding will be required to submit additional certifications and an electronic version of the revised project abstract.  They may also be asked to provide responses to comments or suggestions offered by the peer reviewers and/or a revised budget.  EPA Project Officers will contact the Principal Investigator to obtain these materials.  Before or after an award, applicants may be required to provide additional quality assurance documentation.

EPA Quality Assurance Documentation:  For any project involving data collection or processing, conducting surveys, environmental measurements, modeling, or the development of environmental technology (whether hardware-based or via new techniques), EPA will require the recipient to submit a Quality Management Plan and other appropriate quality assurance documentation on the processes that will be used to assure that results of the research satisfy the intended project objectives. This is not required for application submission, but will be required for any applications that EPA chooses to recommend for funding. More detailed information on requirements can be found at http://es.epa.gov/ncer/guidance/qa.html.

EPA Award Information:  Non-profit applicants that are recommended for funding under this announcement are subject to pre-award administrative capability reviews consistent with Section 8b., 8c. and 9d. of EPA Order 5700.8 - Policy on Assessing Capabilities of Non-Profit Applicants for Managing Assistance Awards (http://www.epa.gov/ogd/grants/award/5700_8.pdf). In addition, non-profit applicants that qualify for funding may, depending on the size of the award, be required to fill out and submit to the Grants Management Office the Administrative Capabilities Form with supporting documents contained in Appendix A of EPA Order 5700.8.

EPA disputes related to this assistance agreement competition will be resolved in accordance with the dispute resolution procedures set forth in 70 FR 3629, 3630 (January 26, 2005) which can be found at http://www.epa.gov/ogd/competition/resolution.htm.  Questions regarding disputes may be referred to the Financial or Grants Management Contact identified below in Section VII.3.

Expectations and responsibilities of EPA/NCER grantees and cooperative agreement holders are summarized in this section, although the terms grant and grantee are used.  See http://www.epa.gov/ncer/guidance for the full terms and conditions associated with an award, including which activities require prior approval from the EPA.

1.   Meetings:  The applicant should budget travel funds sufficient for attendance of the Center Director and Project and Core leaders at an annual meeting, which is a one-and-one-half-day meeting, at the NIEHS in Research Triangle Park, NC or at the US EPA in Research Triangle Park, NC or Washington DC.

2.   Approval of Changes after Award: Prior written approval is required from the EPA if there will be a significant change from the work described in the application.  Examples of these changes are contained in 40 C.F.R. 30.25.  Note: prior written approval is also required from the EPA for incurring costs more than 90 calendar days prior to award.

3.   Human Subjects: A grant applicant must agree to meet all EPA requirements for studies using human subjects prior to implementing any work with these subjects.  These requirements are given in 40 C.F.R. § 26.  Studies involving intentional exposure of human subjects who are children or pregnant or nursing women are prohibited by Subpart B of 40 CFR Section 26.  For observational studies involving children or pregnant women and fetuses please refer to Subparts C & D of 40 CFR Section 26.  U.S. Department of Health and Human Services regulations at 45 CFR § 46.101(e) have long required "... compliance with pertinent Federal laws or regulations which provide additional protection for human subjects."  EPA’s regulation 40 C.F.R. Part 26 is such a pertinent Federal regulation.  Therefore, the applicant's Institutional Review Board (IRB) approval must state that the applicant's study meets the EPA's regulations at 40 CFR § 26. No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the applicant’s IRB approval of the project and the EPA has also provided approval.  Where human subjects are involved in the research, the recipient must provide evidence of subsequent IRB reviews, including amendments or minor changes of protocol, as part of annual reports. 

4.  Animal Welfare: A grant recipient must agree to comply with the Animal Welfare Act of 1966 (P.L. 89-544), as amended, 7 U.S.C. 2131-2156.  The recipient must also agree to abide by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training" (50 Federal Register 20864-20865. May 20, 1985).

5.  Data Access and Information Release: After award, all data (including primary and secondary or existing data) must be made available to the NCER Project Officer without restriction and be accompanied by comprehensive metadata documentation adequate for specialists and non-specialists alike to be able to understand how and where the data were obtained and to evaluate the quality of the data.  If requested, the data products and their metadata must be provided to the NCER Project Officer in a standard exchange format no later than the due date of the grant's final report or the publication of the data product's associated results, whichever comes first.

Congress, through OMB, has instructed each federal agency to implement Information Quality Guidelines designed to "provide policy and procedural guidance...for ensuring and maximizing the quality, objectivity, utility, and integrity of information, including statistical information, disseminated by Federal agencies." The EPA's implementation may be found at http://epa.gov/quality/exmural.html#genreqts.  These procedures may apply to data generated by grant recipients if those data are disseminated as described in the Guidelines.

The Office of Management and Budget (OMB) Circular A-110 located at 2 CFR Part 215 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.  If such data are requested by the public, the EPA must ask for it, and the grantee must submit it, in accordance with A-110 and the EPA regulations at 40 C.F.R. 30.36.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. 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.

As part of good program management, NIH and EPA assess the implementation and effectiveness of their programs using evaluation tools and techniques. Grantees may be asked to provide information for program evaluation purposes, both locally and at the national level. Such information may be used in evaluations of the CEHCs.

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.

EPA Reporting Requirements: A grant recipient must agree to provide annual progress reports, with associated summaries, and a final report with an executive summary.  The summaries will be posted on NCER’s website.

A grant recipient must agree to provide copies of any peer reviewed journal article(s) resulting from the research during the project period.  In addition, the recipient should notify the EPA Project Officer of any papers published after completion of the grant that were based on research supported by the grant.  NCER posts references to all publications resulting from a grant on the NCER web site.

Acknowledgement of EPA Support: EPA’s full or partial support must be acknowledged in journal articles, oral or poster presentations, news releases, interviews with reporters and other communications.  Any documents developed under this agreement that are intended for distribution to the public or inclusion in a scientific, technical, or other journal shall include the following statement:

This publication [article] was developed under STAR Research Assistance Agreement No. __________ awarded by the U.S. Environmental Protection Agency.  It has not been formally reviewed by the EPA.  The views expressed in this document are solely those of [name of recipient] and the EPA does not endorse any products or commercial services mentioned in this publication.

A graphic that may be converted to a slide or used in other ways, such as on a poster, is located at http://es.epa.gov/ncer/guidance/star_images.html.  EPA expects recipients to use this graphic in oral and poster presentations.

EPA, states, territories, and tribes are working together to develop the National Environmental Information Exchange Network, a secure, Internet- and standards-based way to support electronic data reporting, sharing, and integration of both regulatory and non-regulatory environmental data.  States, tribes and territories exchanging data with each other or with EPA, should make the Exchange Network and the Agency's connection to it, the Central Data Exchange (CDX), the standard way they exchange data and should phase out any legacy methods they have been using.  More information on the Exchange Network is available at www.exchangenetwork.net.  

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:

NIEHS:

Kimberly A. Gray, PhD
Division of Extramural Training and Science
National Institute of Environmental Health Sciences
PO Box 12233, K3-12
111 T.W. Alexander Drive
Research Triangle Park, NC, 27709
Telephone: (919) 541-0293
FAX: (919) 316-4606
Email: gray6@niehs.nih.gov

Cindy Lawler, PhD
Division of Extramural Training and Science
National Institute of Environmental Health Sciences
PO Box 12233, K3-15
111 T.W. Alexander Drive
Research Triangle Park, NC, 27709
Telephone: (919) 316-4671
FAX: (919) 316-4606
Email: lawler@niehs.nih.gov

EPA:

Nigel Fields, MSPH
Environmental Health Scientist
National Center for Environmental Research
U.S. Environmental Protection Agency
1200 Pennsylvania, Ave., NW (8723F)
Washington, DC 20460-0001
Telephone:  (202) 343-9767
FAX:  (202) 233-0677
Email:  fields.nigel@epa.gov

Richard Callan, MPH
National Center for Environmental Research
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW (8723F)
Washington, DC 20460-0001
Telephone: (202) 343-9637
FAX:  (202) 233-0677
E-mail: callan.richard@epa.gov 

2. Peer Review Contacts:

Linda Bass, Ph.D.
Division of Extramural Training and Science
National Institute of Environmental Health Sciences
PO Box 12233, K3-03
111 T.W. Alexander Drive
Research Triangle Park, NC, 27709
Telephone: (919) 541-1307
FAX: (919) 541-2503
Email: bass@niehs.nih.gov

3. Financial or Grants Management Contacts:

NIEHS:

Mr. Aaron Nicholas
Division of Extramural Training and Science
National Institute of Environmental Health Sciences
PO Box 12233, K03-11
111 T.W. Alexander Drive
Research Triangle Park, NC, 27709
Telephone: (919) 541-0039
FAX: (919) 316-4606
Email: nicholaa@niehs.nih.gov

EPA:

William Stelz, CPG
Environmental Scientist
National Center for Environmental Research
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW (8721F)
Washington, DC 20460-0001
Telephone: 202-343-9802
Fax: 202-233-0677
E-mail: stelz.william@epa.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide 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.

EPA Geospatial Information
These awards may involve the collection of “Geospatial Information,” which includes information that identifies the geographic location and characteristics of natural or constructed features or boundaries on the Earth or applications, tools, and hardware associated with the generation, maintenance, or distribution of such information.  This information may be derived from, among other things, a Geographic Positioning System (GPS), remote sensing, mapping, charting, and surveying technologies, or statistical data. 

EPA Authority and Regulations  
To be eligible for EPA funding consideration, a project must address the causes, effects, extent, prevention, reduction, and elimination of air pollution, water pollution, solid/hazardous waste pollution, toxic substances control, or pesticide control depending on which statute(s) is/are listed in the section referenced above.  These activities should relate to the gathering or transferring of information or advancing the state of knowledge.  Proposals should emphasize this “learning” concept, as opposed to “fixing” an environmental problem via a well-established method.  Further, applications that fail to demonstrate a public purpose of support or stimulation (e.g., by proposing research which primarily benefits a Federal program or provides a service for a Federal agency) will not be funded.

The specific Strategic Goal and Objective from the EPA’s Strategic Plan that relate to this solicitation are Goal 4: Healthy Communities and Ecosystems, and Objective 4.4: Enhance Science and Research.  The EPA’s Strategic Plan can be found at http://www.epa.gov/ocfo/plan/2006/entire_report.pdf.  The NIEHS strategic plan can be found at http://www.niehs.nih.gov/about/od/strategicplan/index.cfm.

The EPA authority for this FOA and resulting awards is contained in the Safe Drinking Water Act, Section 1442, 42 U.S.C. 300j-1; the Toxic Substances Control Act, Section 10, 15 U.S.C. 2609; the Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r; the Clean Air Act, Section 103, 42 U.S.C. 7403; and the Clean Water Act, Section 104, 33 U.S.C. 1254.  For research with an international aspect, the above statutes are supplemented, as appropriate, by the National Environmental Policy Act, Section 102(2)(F).

Applicable NIH and EPA regulations include: 40 CFR Part 30 (Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations), 40 CFR Part 31 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments) and 40 CFR Part 40 (Research and Demonstration Grants).  Applicable OMB Circulars include: OMB Circular A-21 (Cost Principles for Educational Institutions) relocated to 2 CFR Part 220, OMB Circular A-87 (Cost Principles for State, Local and Indian Tribal Governments) relocated to 2 CFR Part 225, OMB Circular A-102 (Grants and Cooperative Agreements With State and Local Governments), OMB Circular A-110 (Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations) relocated to 2 CFR Part 215, and OMB Circular A-122, (Cost Principles for Non-Profit Organizations) relocated to 2 CFR Part 230.


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NIH Funding Opportunities and Notices


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