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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) (https://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), EPA (https://www.epa.gov/research-grants)

Title:Children’s Environmental Health and Disease Prevention Research Centers: Formative Centers (P20)

Announcement Type
New  

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

  • March 6, 2009 - See NOT-ES-09-005 Amendments and Corrections to this RFA.
  • March 4, 2009 - See Notice (NOT-ES-09-003) This Notice is to inform the scientific community that the NIH and the EPA are revising this funding opportunity.

Request For Applications (RFA) Number: RFA-ES-08-004

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 Dates: April 30, 2009
Peer Review Date: June 2009
Council Review Date: October 2009
Earliest Anticipated Start Date: December 1, 2009
Additional Information To Be Available Date (URL Activation Date):  Not Applicable
Expiration Date: May 1, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

  • Purpose. This Funding Opportunity Announcement (FOA) issued by NIEHS and EPA solicits P20 planning grant applications for Children’s Environmental Health and Disease Prevention Research Centers: Formative Centers (CEHC Formative Centers). This program will support the development of an integrative research environment to sustain a multidisciplinary program of basic and applied research which examines the effects of environmental threats to children’s health and well-being. Research conducted as part of the CEHC Formative Centers should include new and emerging areas of science in children’s health while incorporating innovative technologies and approaches in the pursuit of developing a strong base of science. This opportunity will allow development of new research teams, connections with communities and other stakeholders, and will obtain preliminary data on childhood diseases and disorders where the evidence of an environmental contribution has yet to be fully established or appreciated.  This new program will develop strong links between disciplines in the basic, applied, clinical and public health sciences where collaborations are currently in the formative stages to prevent disease and promote health in all children.
  • Mechanism of Support. This FOA will utilize the P20 grant mechanism and the Environmental Protection Agency's (EPA’s) Office of  Research and Development, National Center for Environmental Research (NCER) STAR (Science to Achieve Results) program administered in accordance with 40 CFR Part 30 and 40.  Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant.  Policies that govern grant award programs of each agency will prevail for respective sources of support. This FOA runs in parallel with RFA-ES-08-002 that solicits applications under the P01 mechanism.
  • Funds Available and Anticipated Number of Awards. The NIEHS and EPA intend to award up to $3 million total each year for 3 years to fund up to four grants for this FOA and intend to award up to $9 million total each year for 5 years to fund up to five grants for its companion FOA for the Children’s Environmental Health and Disease Prevention Research Centers program, RFA-ES-08-002. 
  • Budget and Project Period.  The total project period for an application submitted in response to this FOA may not exceed three years.  Direct costs are limited to $450,000 per year or $500,000.00 if a minimum of $50,000.00 of the budget is allocated for the development and support of a Community Outreach and Translation Core (COTC) (optional).
  • Eligible Institutions/Organizations. Institutions/organizations listed in Section III, 1.A. are eligible to apply.
  • Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution/organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH and EPA support.
  • Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.
  • Resubmissions. Resubmission applications are not permitted in response to this FOA.
  • Renewals.  Renewal applications are not permitted in response to this FOA.
  • Special Date(s). This FOA uses non-standard due dates. See Receipt, Review and Anticipated Start Dates
  • Application Materials. See Section IV.1 for application materials.
  • Hearing Impaired.  Telecommunications for the hearing impaired are available at: TTY: (301) 451-5936.

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 EPA concurrently funded a program called the Centers for Children’s Environmental Health and Disease Prevention Research (Children’s Centers or CEHCs).  (More information is available at http://www.niehs.nih.gov/research/supported/centers/prevention/index.cfm, and https://www2.epa.gov/research-grants/niehsepa-childrens-environmental-health-and-disease-prevention-research-centers.) Combining research and outreach, these Centers form a national network to address a range of childhood diseases and outcomes that may result from environmental exposures, including impairments in overall growth and development, impairments in nervous system development and respiratory dysfunction. Center investigators work closely 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 CEHC structure 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 their research findings into information for the public, policy makers and clinical professionals with the ultimate goal of protecting the health of children.

Scientific Knowledge To Be Achieved:

NIEHS and 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 on children’s health, 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 Scope, Results and Outcomes

NIEHS and 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 to fill the identified research gaps.  This FOA is one of two simultaneous efforts of the joint program that will create the next phase of the Children’s Environmental Health and Disease Prevention Research Centers: Formative Centers (P20) program to foster and stimulate the creation of new collaborative teams to conduct research in children’s environmental health where preliminary data or support may be limited.  A companion announcement, “Children’s Environmental Health and Disease Prevention Research Centers” (P01) may be found at RFA-ES-08-002. 

The CEHC (P01) program is characterized by strong multidisciplinary research with a well-developed program of cutting-edge research and well-developed links to key stakeholder groups including communities, policy makers and health care professionals in order to consider their views in the design of research projects and to enhance the translation of findings to these key audiences. 

Applications for CEHC Formative Centers must identify a central theme and develop scientific approaches to understand the concerns, interests, attributes and needs of different populations and persons in their community regarding children’s environmental health. Formative Centers are intended to facilitate the development of cross-cutting research activities and teams and to support research in children’s health outcomes where the link to the environment is not yet well established.  This FOA encourages applications for P20 planning grants to initiate individual research projects, pilot projects, and Cores that support the integration of center components.

A few examples of activities supported under the P20 funding mechanism: 

  • Developing proof of principle experiments to demonstrate the role of environmental exposures in disease etiology
  • Testing the feasibility of new research tools to assess novel traits or markers related to health outcomes in children
  • Developing new methodologies to enhance the interplay between the basic and social sciences for addressing child health concerns
  • Building new interdisciplinary teams of scientists to develop a novel program in children’s environmental health research and translation not represented in the pre-existing program
  • Defining and understanding populations at greatest risk
  • Creating or improving the relationship between multiple partners including but not limited to communities and academic institutions.

Research topic areas may include (but are not limited to) preterm birth and perinatal outcomes, birth defects, the role of epigenetics in gene-environment interaction, childhood cancers or metabolic disorders like obesity or diabetes or other prevalent disease(s), or other childhood diseases not commonly thought to have a strong environmental component in disease etiology or disease exacerbation yet where preliminary data may be suggestive for such an environmental role. 

Required Components for Formative Centers

  • The CEHC Formative Centers must address an interrelated set of hypothesis-driven research questions that will provide new knowledge about how environmental factors influence the health of children. 
  • The CEHC Formative Center must be conceptualized and organized according to an interdisciplinary framework and must include novel, innovative and creative research questions.
  • Applications must contain the following:
    • a minimum of 3 projects, including at least 1 research project
    • an Administrative Core
    • a Principal Investigator/Center Director committing a minimum of 15% to the Formative Center grant
    • at least one clinical health expert
    • a plan to support career development of junior-level investigators
    • a community engagement plan
  • Applications may include a plan to establish a Community Outreach and Translation Core (optional)

Applications not containing at least three projects, an Administrative Core, a clinical health expert and plans to support career development and community engagement will be considered non-responsive and not be reviewed.

Detailed Description of Formative Center Components

A.      Overall Center

(1)  The CEHC Formative Center must demonstrate the potential for a high degree of collaboration among investigators and across the research projects.  

(2)  CEHC Formative Centers must be comprised of linked research projects and may include facility Cores to service more than one project.  Cores are not intended to provide general infrastructure support to an institution.

B.       The Investigators

(1)  The Center Director should be a senior scientist with substantial research and scholarly experience in the field of children’s environmental health.  S/he must have a demonstrated ability to organize, administer, and direct the Center.  The Director must be the scientific leader of the Center and must also be the Principal Investigator on at least one of the individual research projects.  The Director of a CEHC Formative Center must have a minimum time commitment of 15 percent to the Center grant (including both administrative and research efforts). 

(2)  Principal Investigators (PIs) of individual research projects must be established scientists in a relevant environmental health, child health, behavioral science, neuroscience, or clinical research discipline.   PIs of individual research projects must devote at least 10% effort to Center activities, including leadership of their project.  Due to collaborations among Center investigators, it is expected that in many instances this percentage will be higher.

(3)  The CEHC Formative Centers must have at least one children’s health clinical expert who is an active researcher and who is qualified to assist with coordination and integration of the scientific projects and will help ensure that the science under investigation will translate to clinical practice or positively impact public health. This person may come from any discipline that traditionally has direct contact with young children in a treatment-based environment, albeit 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 children’s health specialist may serve as a project leader or co-leader with additional percent effort.

(4)  The CEHC Formative Center must include a plan to support research career development of new, junior faculty level investigators within the structure of the Formative Center.  This may include having a new investigator as a PI for any one of the three required research projects.  The designated new investigator must meet the NIH definition of New Investigator, http://grants.nih.gov/grants/new_investigators/resources.htm#definition.

C.       Research Projects and Cores

(1)  Individual Research Projects: Funds should be requested to support a minimum of three projects including at least one research project. These individual projects should demonstrate a significant contribution to the other projects and to the Center as a whole and may be any combination of basic and population studies.  Animal studies are acceptable but must show relevance to children’s exposure or disease. Description of projects are provided below: 

o    Research projects.  Minimum cost per research project is $125,000 direct costs per year for up to three years. At least one hypothesis-driven research project per CEHC Formative Center is required.

o    Pilot projects/Feasibility studies.  Research projects of limited scope to generate data needed to demonstrate technical feasibility such as access to study populations or to validate an experimental approach may be proposed. Minimum direct cost per project is $50,000 per year for up to three years.

(2)  Each Formative Center must include an Administrative Core unit to provide oversight, coordination, and integration of Center activities. Plans must be outlined in the application within the Administrative Core for an external advisory board that will serve as an important source of guidance from experts in the field who do not have a vested interest in the Center or in the research to be conducted by the Center.  Funds may be requested to support travel of board members for meetings.  The general composition and areas of expertise of board members should be described in the application.  Do NOT identity proposed board members or contact them before a funding decision has been made.

(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.

(4)  The Formative Center may include a plan to establish a Community Outreach Translation Core (COTC).  The purpose of the COTC is to develop, implement and evaluate strategies to translate and apply the scientific findings of the Center into information for use by the public, policy makers, and clinical professionals to protect the health of children.  

D.      Additional Elements to Accomplish Center Objectives

(1)  The CEHC Formative Center must include a plan to involve the meaningful and active participation of relevant stakeholders who have concerns about children’s environmental health and/or the environmental exposures under investigation.

(2)  The applicant should budget travel funds sufficient for attendance of the Center Director and Project and Core leaders at one 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.

Applicants must study an environmental agent/chemical/stressor to which there is human exposure and the potential for in utero or childhood exposure.  This includes exposures such as endocrine-active chemical(s) or organic solvents, particulate matter (PM), pesticides, phytochemicals or metals.  Nutrition and nutritional supplements, 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 P20 (exploratory grant) award mechanism.

As an applicant, you will have the primary responsibility for planning, directing and executing the proposed project.  The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the P20 mechanism’s aims in the proposed project.

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

2. Funds Available

It is anticipated that an estimated total of $12 million, including direct, facilities and administrative costs, will be available annually for five years for both the Children’s Environmental Health and Disease Prevention Research Centers (P01) and Children’s Environmental Health and Prevention Disease Research Centers: Formative Centers (P20), beginning in FY2009. The NIEHS and EPA intend to award up to $3 million each year for 3 years to fund up to four grants for this FOA and $9 million each year for 5 years to fund up to five grants in response to the companion FOA for the P01 Centers, RFA-ES-08-002. 

  • This FOA will support up to four Formative Centers. 
  • For each Center, the maximum award will be $450,000 in direct costs per year for up to three year project period or up to $500,000 in direct costs if a minimum of $50,000 of the budget is allocated for the support of the Community Outreach Translation Core (COTC).
  • Future year amounts will depend on annual appropriations.
  • Both NIEHS and EPA reserve the right to reject all applications and make no awards, or make fewer awards than anticipated or to make additional awards.

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, then 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 are to provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

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

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education
  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • State Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribally Designated Organizations
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • U.S. Territory or Possession
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • Regional Organizations

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.

The applicant institution may enter into an agreement with a Federal Agency to purchase or utilize unique supplies or services unavailable in the private sector.  Examples are purchase of satellite data, census data tapes, chemical reference standards, analyses, or use of instrumentation or other facilities not available elsewhere.  A written justification for federal involvement must be included in the application.  In addition, an appropriate form of assurance that documents the commitment, such as a letter of intent from the Federal Agency involved, should be included.

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

Resubmission or Renewal applications are not accepted under this FOA.

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

The CEHC Formative Centers must address an interrelated set of hypothesis-driven research questions that will provide new knowledge about how environmental factors influence the health of children. 

The CEHC Formative Center must be conceptualized and organized according to an interdisciplinary framework and must include novel, innovative and creative research questions.

Applications must contain the following or will be considered non-responsive:

  • a minimum of 3 projects, including at least 1 research project
  • an Administrative Core , which will be responsible for maintaining an External Advisory Board
  • a Principal Investigator/Center Director committing a minimum of 15% to the Formative Center grant
  • at least one pediatric health expert
  • a plan to support career development of junior-level investigators
  • a community engagement plan

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

Guidance for Applicants Submitting a P20 Formative Center in Children’s Environmental Health and Disease Prevention Research

All applications received for this FOA will be considered new applications; thus, applications received from investigators who currently hold NIEHS/EPA Children’s Environmental Health and Disease Prevention Center awards will not be considered competing renewals.  

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.

SUPPLEMENTARY INSTRUCTIONS

An application for a Formative Center for Children’s Environmental Health and Disease Research must describe the overall goals of the Center, the hypotheses to be tested, and the methods to be used.  The application must clearly articulate the reasons a Center approach is needed for the proposed activities, as well as the unique benefits that will accrue from a Center.

Information for the Entire Center:

  • Face Page, pertaining to the entire Center.
  • Description, Performance Sites, Key Personnel, Other Significant Contributors, and any use of Human Embryonic Stem Cells (Form Page 2), pertaining to the entire Center.
  • Table of Contents (Form Page 3) for the entire application.
  • Budget (Form Pages 4 and 5).  Categorical figures must be provided to describe the budget of the overall Center.  Since detailed budget justification will be provided separately for each project and core (as described below), only items for which justification is not provided elsewhere should be presented in narrative here.
  • Biographical Sketches of Key Personnel.  These should be provided for key personnel for the entire Center, and should be arranged alphabetically based on the individual’s surname.
  • Resources.  These should be restricted to those not described separately for the individual projects and cores.
  • General Description of the Overall Center (not to exceed 15 pages).  Identify the proposed Center as a Formative Center.  Provide an overview of the entire proposed Center, describing the Center goals and outcomes and how they will be achieved. Explain the proposed contribution of each of the individual projects and cores to achieving the Center’s objectives, and how these components relate to each other scientifically.
  • Evidence of Feasibility and Preliminary Findings (not to exceed 10 pages).  Present evidence that the research team will be able to work together to achieve the research goals of the Center, preliminary results, evidence of competence in the areas proposed, and any other information that speaks to feasibility.
  • Operational Plan for the Overall Center (not to exceed 15 pages).  Describe the working administrative and logistical arrangements, as well as resource support necessary to implement the research.  When multiple institutional sites are involved, a detailed description of the cooperative administrative arrangements should be included (and documented in the “Letters of Support” section).  Also include in this section a description of the manner in which an external advisory board will relate to the Center.  Although the board’s general composition and areas of expertise should be described, prospective board members should NOT be chosen or contacted prior to a funding decision and should not be named in the application.  Finally, describe the plan for sharing research data as well as any research tools and biological material generated by the Center (see Section IV.6).
  • Research Career Development and Community Engagement Plans (not to exceed 4 pages).  Describe how the Center will provide opportunities for junior investigators as well as relationships with training programs of participating institutions.  Also describe plans for how the Center will include the community members or stakeholders in the structure of Center program including approaches and methods to provide a meaningful relationship.  If applicant is including the optional COTC to meet the criteria for Community Engagement, then follow the information for the COTC Core.

Information for Each Project or Core:

  • Title page for the project or core.
  • Form Page 2 referring specifically to the project or core.
  • Budget (Form Pages 4 and 5).  Detailed budgetary information for each project or core, including narrative justification.
  • Resources, referring specifically to the project or core.
  • Research Plan for Individual Projects (not to exceed 15 pages for any one project), Describe the specific aims, research questions/hypotheses to be addressed, background and significance, preliminary findings, and the research design and methods.  Address the status of current research efforts on the topic, the limitations of these, why the particular research question lends itself to a multidisciplinary, integrative approach, and how the proposed project will be linked to and integrated with other proposed Center projects.  Address issues of feasibility, potential pitfalls, alternative approaches, and relevance to Center goals.
  • Descriptions of Individual Cores (not to exceed 15 pages for any one Core).  Describe how the Core will contribute to the overall goals of the Center, including the facilities, resources, services, and professional skills that it will provide.  Describe which specific projects will be supported by the Core and the manner in which that support will be rendered.
  • Human Subjects.  For each individual project and core involving human subjects, describe the plans for protection of subjects from research risks, as well as plans for the inclusion of women, minorities, and children, as described in the PHS Form 398 application instructions.  Address informed consent and confidentiality protections attendant to the sharing of research data.
  • Vertebrate Animals.  For each individual project and core involving non-human vertebrate animals, provide a detailed description and justification for the use of animals as described in the PHS Form 398 application instructions.

Additional Information for the Entire Center:

  • Literature Cited, compiled across all sections of the application.
  • Letters of Support from Collaborating Institutions, compiled across all sections of the application.  Also include in this section assurances from Institutional Review Boards and/or Institutional Animal Care and Use Committees (although the former is not required for peer review).
  • Checklist
  • Personal Data on Center Director including biosketch.

A narrative description should be provided that includes the planning and coordination of research activities; the integration of cross-disciplinary research; 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. Describe how expected research goals outcomes will be measured and tracked toward success. 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.

The applicant should budget travel funds sufficient for attendance of the Center Director and Project and Core leaders at one 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.

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
Letters of Intent Receipt Date: March 30, 2009
Application Receipt Date: April 30, 2009
Peer Review Date: June 2009
Council Review Date: October 2009
Earliest Anticipated Start Date: December 1, 2009

3.A.1. Letter of Intent

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

  • Descriptive title of proposed research
  • Name, address, and telephone number of the Principal Investigator
  • Names of other key personnel
  • Participating institutions
  • Number and title of this funding opportunity

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 CSR and for responsiveness by the reviewing Institute 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 and 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 award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH or EPA prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain approval 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 award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH or EPA 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 proper expenditure of funds. If the award is funded by both NIEHS and EPA then the recipient is accountable to NIEHS and EPA 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.  

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  

The PHS 398 forms must be used when submitting an application in response to this FOA.  Research projects should be no more than 10 pages and the pilot projects should not exceed 5 pages in length. An application that does not observe the required page limitations may be delayed in the review process.

Appendix Materials

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

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

Resource Sharing Plan(s)

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

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

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

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

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 applications will:

  • Undergo a selection process in which only those applications deemed to have the highest scientific and technical merit, generally the top half of applications under review, will be discussed and assigned a priority score.
  • Receive a written critique.
  • Receive a second level of review by the National Institute of Environmental Health Sciences Advisory Council and an EPA Programmatic Review Committee (For EPA criteria, see Section V.2.A below).

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

  • Scientific and technical merit of the proposed project as determined by peer review
  • Availability of funds
  • Relevance of the proposed project to program priorities

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 Center application:

(1) Individual Center Components

  • Individual Pilot/Research Projects
  • Administrative Core
  • Facility/Service Core Unit(s) (optional)
  • Community Outreach and Translation Core (optional)

(2) Review of the Overall Center

Individual Projects

Pilot Projects: Will the pilot project encourage innovative ideas of importance to children’s environmental health? Will the pilot project fill gaps in the research areas relevant to the scientific focus of the Children’s Center Program?

Research Projects: 

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

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

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

Investigator(s).  Are the PD/PIs, collaborators, and oth

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The perspectives, information and conclusions conveyed in research project abstracts, progress reports, final reports, journal abstracts and journal publications convey the viewpoints of the principal investigator and may not represent the views and policies of ORD and EPA. Conclusions drawn by the principal investigators have not been reviewed by the Agency.

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Last updated April 28, 2023