Part I Overview Information


Department of Health and Human Services

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

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

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

Announcement Type
New  

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

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

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

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

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

Background:

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

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

Scientific Knowledge To Be Achieved:

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

Research Scope, Results and Outcomes

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

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

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

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

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

Required Components for Formative Centers

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

Detailed Description of Formative Center Components

A.      Overall Center

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

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

B.       The Investigators

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

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

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

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

C.       Research Projects and Cores

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

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

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

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

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

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

D.      Additional Elements to Accomplish Center Objectives

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

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

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

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the P20 (exploratory grant) award mechanism.

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

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

2. Funds Available

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

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

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

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

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of NIEHS and EPA are to provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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

NIH grants policies as described in the NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Resubmission or Renewal applications are not accepted under this FOA.

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

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

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

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

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

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

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

Section IV. Application and Submission Information


1. Address to Request Application Information

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

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

2. Content and Form of Application Submission

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

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

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

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

SUPPLEMENTARY INSTRUCTIONS

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

Information for the Entire Center:

Information for Each Project or Core:

Additional Information for the Entire Center:

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

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

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

3. Submission Dates and Times

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

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

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

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

3.B. Sending an Application to the NIH

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

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

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

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

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

3.C. Application Processing

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

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

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

4. Intergovernmental Review

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

EPA Supplemental Information:

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

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

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

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH and EPA prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH or EPA prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain approval before incurring the cost. Prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

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

EPA Supplemental Information:

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

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

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

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

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

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

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

6. Other Submission Requirements and Information

Research Plan Page Limitations  

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

Appendix Materials

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

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

Resource Sharing Plan(s)

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

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

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

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

EPA Confidentiality of Submitted Application

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

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

Section V. Application Review Information


1. Criteria

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIEHS and in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.

As part of the scientific peer review, all applications will:

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

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

Peer Review Process

Peer review for scientific and technical merit emphasizes two major aspects of the Center application:

(1) Individual Center Components

(2) Review of the Overall Center

Individual Projects

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

Research Projects: 

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

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

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

Investigator(s).  Are the PD/PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

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

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

Administrative Core

Facility/Service Cores

Community Outreach and Translation Core (optional)

Evaluation of the Overall P20 Center

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

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.

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

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

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

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

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:

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

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

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

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

1.  Name of Granting Agency.

2.  Grant/Cooperative agreement number.

3.  Grant/Cooperative agreement title.

4.  Brief description of the grant/cooperative agreement.

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

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

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

8.  Project period.

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

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

The EPA internal programmatic review panel will assess:

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

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

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information


1. Award Notices

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The OMB Circular A-110 located at 2 CFR Part 215 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances.  Data that are (1) first produced in a project that is supported in whole or in part with federal funds and (2) cited publicly and officially by a federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA.  If such data are requested by the public, the EPA must ask for it, and the grantee must submit it, in accordance with A-110 and the EPA regulations at 40 C.F.R. 30.36.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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

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

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

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

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

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

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

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

EPA:

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

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

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:

NIEHS:
Mr. Aaron Nicholas
Division of Extramural Training and Science
National Institute of Environmental Health Sciences
PO Box 12233, K3-11
111 T.W. Alexander Drive
Research Triangle Park, NC, 27709
Telephone: (919) 541-0039
FAX: (919) 316-4606
Email: nicholaa@niehs.nih.gov

 EPA:

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

Section VIII. Other Information


Required Federal Citations

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

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

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

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

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

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

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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

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

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

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

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

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

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

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

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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NIH Funding Opportunities and Notices


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