Grantee Research Project Results
U.S. Environmental Protection Agency
National Center for Environmental Research
Science to Achieve Results (STAR) Program
National Institutes of Health
National Institutes of Environmental Health Sciences (NIEHS)
CLOSED: FOR REFERENCE PURPOSES ONLY
Centers for Children’s Environmental Health and Disease Prevention Research
This is a modification of RFA03-004 which was previously released January 28, 2003.Funding Opportunity Number: RFA-(ES05-004)
Catalog of Federal Domestic Assistance (CFDA) Number: 93.113
EPA 66.509
Solicitation Opening Date: October 11, 2005
Letters of Intent Receipt Date: October 23, 2005
Application Receipt Dates: November 23, 2005
Peer Review Date: March 2006
Council Review Date: June 2006
Earliest Anticipated Start Date: July 01, 2006
Expiration Date: November 24, 2005
Scientific/Research Contact(s):
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
Email: fields.Nigel@epa.gov
Peer Review Contact(s):
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
Financial or Grants Management Contact(s):
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
Email: winters@niehs.nih.gov
Mr. Tom Barnwell
National Center for Environmental Research
U.S. Environmental Protection Agency (8701F)
1200 Pennsylvania Ave., NW
Washington, DC 20460
Telephone: 202-343-9862
Email: barnwell.thomas@epa.gov
Access Standard STAR Forms and Instructions
Research awarded under previous solicitations
The NIEHS in partnership with EPA invites applications for P01 Research Center grants that will conduct multidisciplinary basic and clinical research using a community-based participatory approach to examine the effects of environmental exposures on children's health and to translate the research findings to public policy, to address community needs, and to information for the health care community and general public.
This RFA will use the National Institutes of Health (NIH) Program Project Grant (P01) and the Environmental Protection Agency's (EPA) Office of Research and Development, STAR (Science to Achieve Results) program administered in accordance with 40 CFR Part 30 and 40. Responsibilities 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.
NIEHS and EPA intend to award up to $ 6 million in FY 2006 to fund three to four grants in response to this RFA. An applicant may request a project period of up to five years and budget for direct costs of up to 1 million in each year.
Eligible organizations include not-for-profit, public or private organizations, units of state and local governments, domestic institutions/organizations, faith-based or community-based organizations, and Native American tribal organizations.
Eligible principal investigators are any individuals with the skills, knowledge, and resources necessary to carry out the proposed research.
The number of applications each applicant may submit is unrestricted.
See Section IV.1 for application materials.
Telecommunications for the hearing impaired is available at: TTY 301-451-0088
SECTION I. FUNDING OPPORTUNITY DESCRIPTION
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:
- mechanistic research including pathophysiology of target-organ system;
- toxicological research;
- molecular and cellular sciences;
- clinical research;
- public health research including epidemiology;
- exposure assessment and remediation;
- behavioral & social sciences;
- cost/benefit analysis;
- and social policy research.
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.
The primary EPA Strategic Goal, Objective and Sub-objective that relates to this solicitation includes: Goal 4: Healthy Communities and Ecosystems, Objective 4.5: Enhance Science and Research, Sub-objective 4.5.2: Conduct Relevant Research. This research will facilitate the collection of human behavioral and other data and thus vastly improve the ability of risk assessors and risk managers to evaluate the contribution of various exposure sources and pathways to the aggregate exposure of individuals and populations to toxic chemicals and the potential and/or resultant adverse health effects that can occur. The desired outcomes of this research are that the data collected will provide scientists and managers in industry, academia and all levels of government with tools valuable for assessing environmental risks in children as required under the Food Quality Protection Act and the Safe Drinking Water Act. This includes pesticide registrants, regional risk assessors, local environmental and health officials, and scientists developing exposure and effects assessment models and software.
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:
- Mental retardation, cerebral palsy, autism spectrum disorders, visual and or hearing impairment, attention deficit and hyperactivity disorders, and affective disorders.
- Delays or deficits in domains of neurodevelopment such as cognition, motor, sensory.
- Thyroid/pituitary dysfunction, puberty and sexual maturation, reproductive development, sexual dimorphic phenotypes, growth disorders or impairments including but not limited to childhood obesity.
- Reproductive outcomes such as preterm delivery, birth defects. Other outcomes associated with nervous and/or endocrine system disruption.
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.
- laboratory basic research project
- clinical research project
- other research project(s)
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:
- Community Outreach and Translation Core (COTC)
- Administrative Core
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:
- Studies focusing on characterizing pathways of exposure; the magnitude, frequency, duration and time-pattern activities which lead to contact in children and quantifying contact rates of children with exposure media, contaminant transfer efficiencies and uptake rates in children.
- Research on behavioral factors that affect exposure and or the ability to reduce exposure.
- Research that characterizes the economic and social impact of children's illnesses on society.
- Evaluation of how scientific information about children's environmental health impacts policy, social change and changes in clinical and public health management of these diseases.
Proposals involving intentional dosing of human subjects will not be considered for award.
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.
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.
Description of Cores
Each Center must include A Community Outreach and Translation Core and an Administrative Core.
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 investigators 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.
This funding opportunity will use the NIH P01 award mechanism and the 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.
It is anticipated that an estimated total of $6 million, including direct, and facilities and administrative (F&A) costs, will be available for the first year of the program in FY2006. Support for these Center grants is contingent upon availability of funds.
Up to $150,000 will be available in total costs per year for up to five years for supplemental funding to foster network collaborations between new and existing Centers. Information about supplemental funding will be disseminated to all awarded Program Directors.
Since the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of the awards will also vary within the funding limits available. The maximum award will be $1 million in direct costs in the first and all subsequent years for all Centers. Indirect costs incurred by including consortia or subcontracts in the application will not contribute to the $1 million cap in direct costs. Funding in subsequent years is contingent upon satisfactory progress during the preceding year and availability of funds.
This program will support up to four Centers in FY 2006.
This program start date is anticipated to be July 01, 2006.
NIEHS and the Environmental Protection Agency intend to commit approximately 6 million dollars in FY 2006 to fund 3-4 centers new 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
You may submit (an) application(s) if your organization has any of the following characteristics:
- Non-profit organizations include any organizations that meet the definition of nonprofit in OMB Circular A-122. However, nonprofit organizations described in Section 501 (c) (4) of the Internal Revenue Code are not eligible to apply.
- Public or private institutions, such as universities, colleges, hospitals, and laboratories, subject to OMB Circular A-21. Profit making firms are not eligible to receive grants from the EPA and NIEHS under this program.
- Units of State government
- Units of local government
- Domestic Institutions
- Faith-based or Native American tribal or other community-based organizations
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.
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.
Cost sharing is not required.
The most current NIH Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.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:
- a laboratory basic research project with an experimental design (required)
- a clinical research project (required)
- Other research project(s)
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.
Proposals involving intentional dosing of human subjects will not be considered for award.
Any application lacking the above special criteria will be considered non-responsive and returned without review.
SECTION IV. APPLICATION AND SUBMISSION INFORMATION
You may submit either a paper application or an electronic application (but not both) for this announcement. Instructions for both forms of submission follow.
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 301-451-0088.
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.
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
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 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.
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.
Confidentiality
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 Agency for the express purpose of assisting the Agency 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/proposal 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, which can be found at https://www.epa.gov/epahome/cfr40.htm. Applicants must clearly mark applications/proposals or portions of applications/proposals they claim as confidential. If no claim of confidentiality is made, the EPA is not required to make an inquiry to the applicant otherwise required by 40 CFR 2.204(c)(2) prior to disclosure.
For EPA, disputes related to this assistance agreement competition will be resolved in accordance with the dispute resolution procedures set forth in 70 Federal Register 3629, 3630 (January 26, 2005) which can be found at https://www.epa.gov/ogd/competition/resolution.htm. Questions regarding disputes may be referred to the EPA Financial/Grants Management Contact identified below.
Nonprofit applicants recommended for funding under this announcement will be subject to a preaward administrative capability review consistent with sections 8.b, 8.c, and 9.d of EPA Order 5700.8, EPA Policy on Assessing Capabilities of Non-Profit Applicants for Managing Assistance Awards (https://www.epa.gov/ogd/grants/regulations.htm).
This initiative is not subject to intergovernmental review.
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 https://www.epa.gov/research-grants/research-grants-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/grants/policy/nihgps_2003/NIHGPS_Part6.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 DataThe 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/grants/policy/nihgps_2003/index.htm and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.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
The following will be considered in making funding decisions:
- Scientific merit of the proposed project as determined by peer review
- Availability of funds
- Relevance of program priorities
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:
- Undergo a selection process in which only those applications deemed to have the highest scientific 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 Advisory of Environmental Health Sciences Council
- Receive a second level of review by EPA’s internal review committee
The goals of NIH and EPA supported research for this RFA 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 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.