Part I Overview Information

Department of Health and Human Services

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

Components of Participating Organizations
National Institutes of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov)
National Center for Environmental Research, U.S. Environmental Protection Agency (EPA), (http://www.epa.gov/ncer)

Title: Centers for Children's Environmental Health and Disease Prevention Research

Announcement Type
This is a modification of RFA-ES-03-004, which was previously released January 28, 2003.

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

Request For Applications (RFA) Number: RFA-ES-05-004

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

Key Dates
Release Date: August 24, 2005
Letters of Intent Receipt Date(s): October 23, 2005
Application Receipt Dates(s): November 23, 2005
Peer Review Date(s): March 2006
Council Review Date(s): June 2006
Earliest Anticipated Start Date: July 01, 2006
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: November 24, 2005

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
   4. Intergovernmental Review
   5. Funding Restrictions

 Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
     A. Additional Review Criteria
     B. Additional Review Considerations
     C. Sharing Research Data
     D. Sharing Research Resources
   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

Purpose

The current initiative continues NIEHS' and EPA's intent to foster advances in children's health by supporting innovative, state of the art Research Centers examining the adverse health effects of environmental exposures among children. Both agencies are interested in reducing environmental risks to children and alleviating the societal burden of environmentally-induced disease/dysfunction.

Collaborative, multidisciplinary research approaches are required to explore the dynamic interaction of children and the environment. Centers are expected to have fully coordinated programs that incorporate exposure and health effects research to support the development and validations of novel health promotion strategies. A Center should identify a central theme or focus of its research effort so that the proposed projects are responsive to the specific research area of children's environmental health included in this Center program.

The program emphasizes integration of basic and population sciences while utilizing a community-based participatory research (CBPR) approach. By bridging gaps between basic and clinical research and between institutional researchers and community members, this program aims to improve our knowledge regarding detection, treatment, and prevention of environmentally-induced disease/dysfunction in children.

Goals, Expected Outcomes and Outputs

The long-range goals of this program include the following: (1) to stimulate new and expand existing research on the role of environment in the etiology of disease/dysfunction among children, (2) to develop novel effective intervention and prevention strategies, and (3) to promote translation of basic research findings into applied intervention and prevention methods, thereby enhancing awareness among children, their families, and health care practitioners regarding detection, treatment, and prevention of environmentally related diseases and health conditions.

A spectrum of scientific approaches is expected to create a truly multidisciplinary working environment where basic research can inform clinical research. These may include:

Each Center must produce a synergistic research environment that allows each research effort to share the creative strengths of the others. Each Center, by supporting interrelated projects and collaborating investigators, is expected to yield results beyond those achievable were each project pursued separately and without formal interaction among the participating investigators. The demonstration of synergy among the projects and the multidisciplinary nature of the work are critical components of this program Ultimately the expected outcomes of this research program include: (a) the generation of cutting-edge science, (b) the development of local and national networks of children's environmental health research professionals, and (c) peer reviewed data relevant to better understanding vulnerability and risk. Expected outputs from each Center include: (a) contributions to the scientific literature and (b) translational outreach and communication tools developed with and applicable for the effected community of concern.

Research Areas of Interest

For the purpose of this current RFA, NIEHS and EPA will accept applications focused on environmentally mediated disorders/dysfunctions of the nervous and/or endocrine systems. Applicants must study an environmental agent/chemical/stressor to which there is human exposure and the potential for in utero exposure. This includes any endocrine active chemical(s) or organic solvents, particulate matter (PMs), pesticides, nutritional supplements, phytochemicals or metals. Nutrition, social and cultural factors can not be considered alone. Applicants are encouraged, however, to incorporate these factors in assessing the effects of previously described environmental exposures. The following is a list of areas of interest:

Required Components

The minimal requirements for a Center for Children's Environmental Health and Disease Prevention Research are described below.

Each Center will propose an overall research mission and plan that is responsive to the objectives of the NIH Center Program. The application must contain a minimum of three research projects, including the first two listed below.

At least one of the three projects must utilize the Community-Based Participatory Research (CBPR) process as defined below.

Applications lacking the first two projects and a project utilizing the CBPR process will be considered non-responsive and returned without review.

Each Center must also include the following two cores:

Applications lacking these two cores will be considered non-responsive and returned without review.

Detailed Description of Projects and Process

Laboratory based research projects may include mechanistic studies of environmental agents that contribute to adverse health outcomes in children as well as research that will improve our basic understanding of pathophysiology, molecular genetics, or cell biology of the developmental processes of interest. Basic mechanistic research pertaining to the central theme may fall into any of the following disciplines: toxicology, cell and molecular biology, physiology, psychology, genetics or other relevant fields. These projects may include methods using animal models, in vitro systems, and/or human clinical specimens.

Clinical research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. For the purpose of this RFA, two types of clinical research would be accepted: (1) patient-oriented research (mechanisms of human disease, therapeutic interventions, clinical trials), (2) epidemiologic and behavioral studies. Clinical research that explores gene and environmental interactions in risk of disease/dysfunction is highly encouraged

At least one other “research project(s)” must be proposed. The additional project (s) must be thematically related and integrated with the above two projects. The following are some examples that would be considered responsive:

Description of Community-Based Participatory Research (CBPR)

CBPR is defined as scientific inquiry conducted in communities and in partnership with researchers. The process of scientific inquiry is such that community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the community's health, have the opportunity to be full participants in each phase of the work (from conception - design - conduct - analysis - interpretation - conclusions - communication of results). CBPR is characterized by substantial community input in the development of the project.

Community refers to populations that may be defined by: geography; race; ethnicity; gender; sexual orientation; disability, illness, or other health condition; or to groups that have a common interest or cause, such as health or service agencies and organizations, health care or public health practitioners or providers, policy makers, or lay public groups with public health concerns. Community-based organizations refer to organizations that may be involved in the research process as members or representatives of the community. While not an exhaustive list, organizations as varied as Tribal governments and colleges, state or local governments, independent living centers, other educational institutions such as junior colleges, advocacy organizations, health delivery organizations (e.g., hospitals), health professional associations, non-governmental organizations, and federally qualified health centers are possible community partners.

Community Outreach and Translation Core (COTC) is required, the purpose of which is to develop, implement and evaluate strategies to translate and apply the scientific findings of the Center into information for the public, policy makers, 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. It is anticipated that a Center will devote at least 10 percent of its budget to the COTC.

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 must be established. This group should consist of a group of three to five scientists, having expertise appropriate for the Center's research focus, plus one representative from a community-based organization involved in community-based research. Representation from a state or local health department is also encouraged. At least 67 percent of Committee members should be from outside the grantee institution. The membership of the Advisory Committee must be approved by the funding agency. 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. Names should not be 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.

Each Center may support other cores that provide a technique, service, or instrumentation that will enhance ongoing research efforts. Examples include animal resources, cell/tissue culture, pathology, biostatistics, molecular biology, neuropsychology, neuroimaging, analytical chemistry, exposure assessment, genotyping and resequencing.

Budgeted Center projects as well as research projects external to the Center may have access to these cores. The application should provide a total operational budget for each facility core together with the percentage of support requested from the Center grant. The application should explain the organization and proposed mode of operation of each core, including a plan for usage, priority setting, allocation of resources, and any applicable charge-back system.

Within the Center Program, PIs are encouraged to support training of new investigators with in the proposed projects. New investigator should have a doctoral level degree with fewer than eight years of postdoctoral level experience at the time of submission of the application, and have demonstrated outstanding abilities in the basic, clinical or population based research. Relevant postdoctoral experience includes postdoctoral research experience in any environment (academic, industry, government). However, years of clinical training will not count against the limitation. Ineligible individuals include current and former principal investigators on EPA STAR Grant or NIH research project (R01), sub-projects of program projects (P01) or Center Grants with research components (P50) or equivalent research grant awards. Applicants will be expected to devote at least 50% time and effort to the award and have a long-term commitment to research in the environmental health sciences.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the NIH P01 award mechanism and t he Environmental Protection Agency's (EPA) Office of Research and Development, STAR (Science to Achieve Results) Grant awards .

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

NIEHS and the Environmental Protection Agency intend to commit approximately 6 million dollars in FY 2006 to fund 3-4 centers n ew and/or competing Centers in response to this RFA.

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.

Any contracts for services or products funded with EPA financial assistance must be awarded under the competitive procurement procedures of 40 CFR Part 30. Moreover, naming a specific contractor in the application does not relieve the applicant of its obligations to comply with competitive procurement requirements. Also, the EPA regulations contain limitations on consultant compensation.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Partnerships between researchers and members of community-based organizations, faith-based or grass roots advocacy organizations or Native American tribal organizations that are concerned with children's health or environmental health issues are required.

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 grant 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.

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.

Potential applicants are uncertain of their eligibility should contact Program staff listed under Section VII.1

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

Cost sharing is not required.

The most current NIH Grants Policy Statement can be found at: http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#matching_or_cost_sharing.

3. Other-Special Eligibility Criteria

Program Director of each Children's Environmental Health and Prevention of Disease Center will be required to commit a minimum of 20% effort to the Center.

Each Center will propose an overall research mission and plan that is responsive to the objectives of the Center Program. The application must contain a minimum of three research projects, including:

At least one of the three projects must utilize the CBPR process in partnership with the community/community-based organization, and the project and approach need to be clearly identified in the proposal.

Each Center must include a Community Outreach and Translation Core (COTC).

Each Center must include an Administrative Core unit to provide overall oversight, coordination, and integration of Center activities including an External Advisory Committee.

Applicants must study an environmental agent/chemical/stressor to which there is human exposure and the potential for in utero exposure. This includes any endocrine active chemical(s) or organic solvents, particulate matter (PMs), pesticides, nutritional supplements, phytochemicals or metals. Nutrition, social and cultural factors cannot be considered alone.

Any application lacking the above special criteria will be considered non-responsive and returned without review.

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 on line 2 of the face page of the application form and the YES box must be checked.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions. A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

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

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: October 23, 2005
Application Receipt Date(s): November 23, 2005
Peer Review Date: March, 2006
Council Review Date: June, 2005
Earliest Anticipated Start Date: July 1, 2006

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 NIH staff to estimate the potential review workload and plan the review. Review staff at NIEHS will distribute a copy of each letter of intent received to NIEHS and EPA Program staff.

The letter of intent is to be sent by the date listed at the beginning of this document.

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 research grant applications 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

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf.

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the NIH Center for Scientific Review and responsiveness by the National Institute of Environmental Health Sciences. Incomplete and non-responsive applications will not be reviewed.

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

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm.

EPA grant awards will be made under the Science To Achieve Results (STAR) program and are subject to the terms and conditions found at http://es.epa.gov/ncer/guidance.

The funding mechanism for all awards issued under this solicitation will consist of assistance agreements. In accordance with the Federal Grant and Cooperative Agreement Act, 31 U.S.C. 6301 et sea., the primary purpose of a grant is to accomplish a public purpose of support or stimulation authorized by federal stature, rather than acquisition for the direct benefit or use of the Agency. In issuing a grant agreement, the EPA anticipates that there will be no substantial EPA involvement in the design, implementation, or conduct of the research. However EPA will monitor research progress through annual reports provided by grantees and other contracts, including site visits, with the Principal Investigator.

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 competing continuation award if such costs: are necessary to conduct the project, and 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 NIH and EPA approval before incurring the cost. NIH and EPA prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing 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 and EPA expect the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

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

Annual Center's Meeting: A two day annual meeting will be held in Washington, D.C. or Research Triangle Park, NC. Applicants must budget travel costs associated with the meeting for the Principal Investigator and the director of each project and the COTC in their applications.

Information Exchange: In addition, since these Centers include community-based research, applicants are expected to maximize opportunities for information exchange between institutional researchers and community members. As part of this program, applicants must generate a report that describes community input, program implementation, and relevant findings. This report must be produced at least annually and distributed among community members in such a way that the public can easily comprehend it. Applicants must budget for production and dissemination of such reports.

Quality Assurance: EPA regulations as stated in 40 CFR30.54 require the inclusion of a Quality Assurance Statement for each individual project supported by a center and a Quality Management Plan for the overall center organization. Together these documents provide information on how quality processes or products will be assured in order to meet the EPA requirement that awards involving environmentally related measurements or data generation have a quality system in place that complies with the requirements of ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs."

A Quality Assurance Statement (QAS) must be submitted for each project proposed in any application submitted in response to this RFA. Each QAS should not exceed two pages. This Statement should, for each item listed below, present the required information, reference the specific page and paragraph number containing the information, or provide a justification as to why the item does not apply to the proposed research.

1. Identify the individual who will be responsible for the quality assurance and quality control aspects of the research. [Quality assurance (QA) is an integrated system of management activities involving planning, implementation, documentation, assessment, and improvement to ensure that a process or item is of the type and quality needed for the project. Quality control (QC) is the system of technical activities that measures the attributes and performance of a process or item against defined standards to verify that they meet the stated requirements.]

2. Discuss the activities to be performed or the hypothesis to be tested and criteria for determining acceptable data quality. Such criteria may be expressed in terms of precision, accuracy, representativeness, completeness, and comparability or in terms of data quality objectives or acceptance and evaluation criteria. These criteria also must be applied to determine the acceptability of existing, or “secondary,” data to be used in the project, and their use discussed. (In this context, secondary data may be defined as data previously collected for other purposes or from other sources.)

3. Describe the study design. Include sample type(s) and location requirements, all statistical analyses that were or will be used to estimate the types and numbers of physical samples required, or equivalent information for studies using survey and interview techniques, or describe how new technology will be benchmarked to improve existing processes, such as those used by industry.

4. Explain how the effectiveness of any new technology or process will be measured. Describe the procedures that will be used in the calibration and performance evaluation of all analytical instrumentation and all methods of analysis to be used during the project.

5. Describe the procedures for the handling and custody of samples, including sample collection, identification, preservation, transportation, and storage, or how the accuracy of test measurements will be verified.

6. Discuss the procedures for data reduction and reporting, including a description of all statistical methods to make inferences and conclusions, with identification of any statistical software to be used. Discuss any computer models to be designed or utilized and describe the associated verification and validation techniques.

7. Describe the quantitative and/or qualitative procedures that will be used to evaluate the success of the project, including any plans for peer or other reviews of the study design or analytical methods prior to data collection. .

ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs," is available for purchase from the American Society for Quality, phone 1-800-248-1946, item T55. Only in exceptional circumstances should it be necessary to consult this document.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Plan for Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm#_Toc54600131). Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. Also, the effectiveness of the resource sharing will be considered as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Budgeting For Cores

The application should provide a total operational budget for each facility core together with the percentage of support requested from the Center grant. The application should explain the organization and proposed mode of operation of each core, including a plan for usage, priority setting, allocation of resources, and any applicable charge-back system.

URLs in NIH Grant Applications or Appendices:

All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the National Institute of Environmental Health Sciences and the Environmental Protection Agency in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Peer review for scientific and technical merit emphasizes two major aspects of the program project application: (1) review of the individual research projects and core unit(s), and (2) review of the program as an integrated research effort focused on a central theme.

The relationship and contributions of each research component and core (excluding those removed through recommendations by the SEP) to the overall theme of the program project are discussed and evaluated. Although projects not recommended for inclusion in the program automatically are removed from consideration as part of the overall program project, such projects will reflect on the leadership capabilities of the Principal Investigator and shall be considered in the overall merit.

The overall Research Program Project Grant application is evaluated considering the remaining projects, supporting cores, and the administrative structure. For the program project to receive a priority score, it must consist of at least three projects (each found to have significant and substantial merit) for the duration of the project period. Each core must provide essential functions or services for at least two of these projects.

The individual projects are evaluated on the basis of the following criteria: 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?

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

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

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

The Administrative Core is assessed based on the following criteria:

The Facility/Service Core(s) is assessed based on the following criteria:

Additionally the overall program is assessed based on the following criteria:

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

Review guidelines for this RFA have been modified from the NIEHS unsolicited Program Project (P01), refer to http://www.niehs.nih.gov/dert/programs/p01guide.htm#CRITERIA.

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 priority score:

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

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

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions 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.

EPA Internal Review Criteria

Applications receiving high scores in the review of scientific and technical merit (peer review process) will then undergo a programmatic review 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. The internal programmatic review panel considers the relevance of the proposed science to EPA research priorities, program balance, the applicant's past performance and reporting, organizational experience, and available program funds from within EPA.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps/part_ii_5.htm#availofrr and http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The NIEHS maintains a resource center of environmental health outreach and education materials developed by NIEHS-funded grantees within a variety of grant programs, including the Centers for Children's Environmental Health and Disease Prevention Research. Children's Center grantees are expected to contribute materials they develop as part of their outreach and education efforts. Grantees will be provided instructions on how to submit materials to the resource center. The purpose of the resource center is to 1) help NIEHS program staff know the amount and variety of materials being developed; 2) assist grantees when developing materials, so they can learn from the experiences of one another; and 3) benefit the general public from the diversity of environmental health information produced by NIEHS grantees. The website is: http://www-apps.niehs.nih.gov/outreach-education/.

Program staff will be responsible for the administrative assessment of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

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

2. Administrative and National Policy Requirements

Awards through this program will include the following special terms and conditions:

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

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

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:

Kimberly A. Gray, PhD
Division of Extramural Training and Science
National Institute of Environmental Health Sciences
PO Box 12233, EC-21
111 T.W. Alexander Drive
Research Triangle Park, NC, 27709
Telephone: (919) 541-0293
FAX: (919) 316-4606
Email: kg89o@nih.gov

Chris Saint, Ph.D.
Assistant Director
National Center for Environmental Research
U.S. Environmental Protection Agency (8723R)
1200 Pennsylvania Ave., NW
Washington, DC 20460
Telephone: 202-564-6909
Fax: 202-565-2448
E-mail: saint.chris@epa.gov

Nigel Fields, M.S.P.H.
Environmental Health Scientist
National Center for Environmental Research
U.S. Environmental Protection Agency (8723F)
1200 Pennsylvania, Ave., NW
Washington, DC 20460
Telephone: (202) 343-9767
FAX: (202) 233-0677
E-mail: fields.Nigel@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, EC-30
111 T.W. Alexander Drive
Research Triangle Park, NC, 27709
Telephone: (919) 541-1307
FAX: (919) 541-2503
E-mail: bass@niehs.nih.gov

3. Financial or Grants Management Contacts:

Ms. Carolyn Winters
Division of Extramural Training and Science
National Institute of Environmental Health Sciences
PO Box 12233, EC- 2286
111 T.W. Alexander Drive
Research Triangle Park, NC, 27709
Telephone: (919) 541-7823
FAX: (919) 541-
E-mail: winters@niehs.nih.gov

Mr. Jack Puzak
Deputy Director
National Center for Environmental Research
U.S. Environmental Protection Agency (8701R)
1200 Pennsylvania Ave., NW
Washington, DC 20460
Telephone: 202-564-6825
Fax: 202-565-2444
E-mail: puzak.jack@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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

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.

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. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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

Awards made by EPA are made under the authority of 40 CFR 30 and 40 and are directly related to the EPA strategic Plan and can be found at http://www.epa.gov/ocfo/plan/plan.htm.

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

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


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