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Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)

Components of Participating Organizations
National Institute of Environmental Health Sciences (NIEHS), (http://www.niehs.nih.gov/)

Title: Outstanding New Environmental Scientist Award (ONES) (R01)

Announcement Type
This is a reissue of RFA-ES-06-007, which was previously released on July 19, 2006.

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

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Request for Applications (RFA) Number: RFA-ES-07-005

Catalog of Federal Domestic Assistance Number(s)
93.113

Key Dates
Release/Posted Date: September 12, 2007
Opening Date: November 10, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 13, 2007
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s): December 10, 2007
Peer Review Date(s): March-April 2008
Council Review Date(s): May 2008
Earliest Anticipated Start Date(s): July 1, 2008
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: December 11, 2007

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

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

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

Section VII. Agency Contacts
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

As emphasized in the new Strategic Plan for the National Institute of Environmental Health Sciences an essential element of the mission of the Institute is the support and career promotion of the future generation of exceptionally talented and creative new scientists who will further the understanding of the impact of environmental exposures on human health. The NIEHS supports a number of training and fellowship programs for pre and postdoctoral training, and mentored career development awards for faculty in the early stages of their career development. Primary among these are the Ruth Kirschstein National Research Service Awards for pre and postdoctoral training, the Career Development Awards for clinically trained scientists (K08 and K23), and the Mentored Quantitative Research Career Development Awards (K25) to support the career development of scientists with quantitative and engineering backgrounds who wish to integrate their expertise with biomedicine. In 2005 the National Institutes of Health announced the Pathway to Independence Award (K99/R00) to address the progression of individuals from postdoctoral positions to faculty positions. In these career development awards the individual applies for the grant while still in a postdoctoral position, and the grant for start-up research funding is awarded at the institution where the candidate accepts the faculty position. However, even with these career development mechanisms in place, to fulfill its mission of assuring a cadre of productive environmental health science investigators for the future, NIEHS needs to initiate further imaginative programs to identify the best new biomedical investigators and facilitate their establishing vibrant, independent research programs in the environmental health sciences.

Research Goals and Scope

In order to identify outstanding scientists at the formative stages of their career and assist them in launching an innovative research program with a defined impact in the environmental health sciences, the NIEHS is establishing a program of R01 research grants intended for researchers who have not received their first R01 research grant. It is designed to be highly competitive, and only a limited number will be awarded per year.

Research programs supported by this announcement seek to promote career advancement of the most highly creative and promising new scientists who intend to make a long-term career commitment to research in the mainstream of the environmental health sciences, and bring innovative, ground-breaking research initiatives and thinking to bear on the problems of how environmental exposures affect human biology, human pathophysiology and human disease.

The R01 applications in this program are distinguished from other R01 research grants in that the applications 1) incorporate a statement of career goals in the environmental health sciences, 2) include a discussion of previous research experience and achievements in addition to the research proposal, 3) may include active participation of an external advisory committee, 4) require demonstration of the commitment by the institution to actively support the research program development of the Principal Investigator, and 5) include a separate budget specifically devoted to equipment and career enhancement activities.

Research projects proposed in response to this Request for Applications will be expected to have a defined impact on the environmental health sciences and be responsive to the mission of the NIEHS, which is distinguished from that of other Institutes by its focus on research programs seeking to link the effects of environmental exposures to the cause, mechanisms, moderation, or prevention of a human disease or disorder or relevant pathophysiologic process. For purposes of this announcement, all applications must focus on a specific human disease, dysfunction, pathophysiologic condition, or relevant human biologic process and propose to study a specific environmentally relevant toxicant. Examples of environmentally relevant toxicants include industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates or fibers, fungal, and bacterial or biologically derived toxins. Agents considered non-responsive to this announcement include, but are not limited to: alcohol, chemotherapeutic agents, radiation which is not a result of an ambient environmental exposure, smoking, except when considered as a secondary smoke exposure as a component in the indoor environment (particularly in children), drugs of abuse, pharmaceuticals, dietary nutrients, and infectious or parasitic agents, except when these are disease co-factors to an environmental toxicant exposure to produce the biological effect. Applications which propose to study only model compounds must provide a clear, reasonable and specific description as to how research on the model compound will lead to a better understanding of the mechanisms involved in responses to specific environmental agents which are included in the mission responsibility of the NIEHS. The peer review committee will assess whether or not the applicant has made sufficient justification to study the model compound. Ecologic, biomonitoring, biotransformation, environmental engineering or biodegradation studies are also not responsive, except when these elements are incidental to the study of the disease endpoint.

As part of the rationale for the study, applicants involving animal exposures must include a justification of how the exposure paradigm is relevant to human exposure and clearly discuss the link between the exposure and the relevant human disease in the Background and Significance section of the application. In addition, the applicant should discuss the potential for translation of the research, which is defined as applying the ideas, insights, and discoveries generated through the basic inquiry to the treatment or prevention of human disease. Applicants proposing epidemiological research are expected to address how the significant associations revealed in the studies could be confirmed in the laboratory setting.

It is anticipated that the ONES program would be evaluated on a continuing basis by the NIEHS, to assess the impact of the program on the portfolio of the NIEHS, as well as on the progression of the awardees' careers. Metrics to be used include, but are not limited to: publications, both numbers and impact factors of publications; academic promotion of Principal Investigators; awards, invited talks at national/international symposia, students and postdoctorals trained in the Principal Investigator's laboratory, and honors received by Principal Investigators; committee service of Principal Investigators; and subsequent grant support awarded. The design of the program evaluation will be determined by the Program Analysis Branch of the Division of Extramural Research and Training. Principal Investigators of awarded ONES grants will be requested to provide information for the evaluation and any subsequent program evaluations for a period of up to ten years after the award.

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 Announcement (FOA) will use the NIH Research Project Grant (R01) award mechanism.

The applicant will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses Just-in-Time information concepts. It also uses the non-modular budget format. A detailed categorical budget for the Initial Budget Period and the Entire Period of Support is to be submitted with the application. Applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.

Competing renewals will be allowed, but will be considered as unsolicited R01 funding opportunities.

2. Funds Available

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 the Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

NIEHS intends to commit up to 2.4 million dollars in direct costs ($3.6 million in total costs) in FY 2008 to fund 6 new grants in response to this FOA. An applicant may request a project period of up to 5 years and a budget for direct costs up to $400,000 dollars in the first and second years and $275,000 in years 3-5. See Section IV.6. Other Submission Requirements below for details on the breakdown of the budget. NIEHS intends to release this FOA again in each of the next two years, contingent on availability of funds.

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

F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

Foreign institutions are not eligible to apply.

Only one application per school or college within a university will be accepted. For example, within a university, one application can be submitted from each of the schools of medicine, public health, arts and sciences, etc. If more than one application from the same grantee entity is submitted, all will be returned without review.

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PI and who meets the criteria listed below is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

To be eligible for this award, applicants must have a Ph.D., M.D., or equivalent graduate degree.

This Funding Opportunity Announcement will not utilize the multiple PI and PD options.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants must have faculty appointments which are tenure track or equivalent, generally at the level of Assistant Professor, Research Assistant Professor, or equivalent, have a research or health professional 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. Individuals must show they have established research independence from a mentor, and have dedicated, independent laboratory and research resources available to conduct the research proposed in the grant application. Relevant postdoctoral experience includes all postdoctoral experience in any environment (academic, industry, government) since receiving a doctoral level research degree. In other words, researchers who received their doctoral degree prior to 1999 are not eligible for this award. However, years of clinical training will not count against the limitation.

Applicants must have research career and a long-term commitment to a career in environmental health research consistent with the core mission areas of the National Institute of Environmental Health Sciences. The NIEHS will decline applications not considered central to either to the mission or the research priorities of the NIEHS as part of the initial evaluation for responsiveness.

Ineligible individuals include current and former Principal Investigators on NIH research project (R01), sub-projects of program project (P01) or Center Grants with research components (P50), and equivalent research grant awards. Individuals who have been Principal Investigators on R03, R21, and Career Development Awards (K-series) remain eligible.

Applicants may not simultaneously submit identical/essentially identical applications under both this FOA and another HHS funding opportunity announcement. Investigators who have another scientifically distinct R01 application pending at the time of the ONES receipt deadline, i.e., submitted June 5 or July 5 for review at January Council, are eligible to submit a ONES application for a different project. However, since the ONES award is designed for new investigators who do not have R01 support, individuals who receive a fundable score and accept funding for the regular R01 prior to the award of the ONES grant are not eligible to receive the ONES award. The individual may defer activation of the R01 until after selection of the ONES awardees has been made. If his or her ONES application is not chosen for funding, he/she may activate the regular R01. If the ONES application is chosen for funding, the applicant will have to decide which grant to accept, but may not accept both.

Only one application per school or college within a university will be accepted.

Applicants must devote at least 50% time and effort to the grant. However, if during the tenure of this grant, should the PI be successful in obtaining funding through another R01 or similar award, the percent effort on the ONES award may be negotiated with the NIEHS program staff down to no less than 30%. In addition, the awardees' departments are encouraged to provide an additional 25-30% release time commencing clinical, teaching, and administrative duties in order to allow the awardees to devote a larger percentage of time to research efforts.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Principal Investigator (PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-710-0267, Email: [email protected].

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget or Research & Related Budget, as appropriate (See Section IV.6., Special Instructions, regarding appropriate required budget component.)

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: November 10, 2007(Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): November 13, 2007
Application Submission/Receipt Date(s): December 10, 2007
Peer Review Date(s): March-April 2008
Council Review Date(s): May 2008
Earliest Anticipated Start Date(s): July 1, 2008

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 IC 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:

Janice Allen, PhD
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 TW Alexander Drive
Building 4401, Room 3170B
Research Triangle Park NC 27709
Telephone: (919) 541-7556
FAX: (919) 541-2503
Email: [email protected]

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

In order to expedite the review, applicants are requested to notify the NIEHS Referral Office by email [email protected] when the application has been submitted. Please include the FOA number and title, PI name, and title of the application.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIEHS. Incomplete and non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

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.

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH 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 renewal (formerly competing continuation ) award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH 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 renewal award.

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

6. Other Submission Requirements

PI Credential (e.g., Agency Login)

The NIH requires the PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Special Instructions for Modular Grant applications

R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.

Foreign organizations may not submit modular budgets. See NOT-OD-06-096.

In addition to the Instructions in the PHS 398 for preparation of an R01 research grant application, the following information must be included in the application:

Future Goals and Objectives and Biography:

Two narrative presentation sections entitled Future Goals and Objectives and Biography, respectively, should be included in the application as attachments (Item 11, under 4.4 Other Project Information Component. The Future Goals and Objectives section (one page maximum) should briefly describe the career track vision and long-term research interests/objectives of the Principal Investigator. The Biography section (two page maximum) should describe the applicant's scientific development from graduate school, the postdoctoral experience(s), through the present faculty position. For each training/research experience, the applicant should describe his/her role in the laboratory or project and cite relevant publications that resulted from the experience.

Career Enhancement Activities and Laboratory Equipment:

As part of the Budget Justification Attachment of the SF 424 (R&R) Budget, the applicant should describe the new enhanced research skills and knowledge expected to be acquired during the five-year term of the award and describe how equipment/resource development funding requested in the budget will contribute to the research productivity of the Principal Investigator or provide for new approaches or directions of investigation. Activities with the potential to allow the Principal Investigator to expand the scope of the research in order to improve the potential for successful renewal of the application are particularly encouraged. The Principal Investigator should describe any activities anticipated, whether included in the budget request or not. Activities may include short courses, technique workshops, visits to laboratories of experienced investigators to learn new methodology, Gordon Conferences, etc. Such activities are intended to enhance the research career of the PI; therefore, this portion of the budget should focus on educational opportunities rather than research dissemination. Travel associated with scientific meetings for the purpose of disseminating research findings should not be included in the career enhancement activities.

Research Plan:

The Research Plan (Specific Aims, Background and Significance, Preliminary Studies, Research Design and Methods sections) should follow in the PHS 398 directions for page limitations, font size, type density and margins. The Research Plan should follow the PHS 398 grant application organization and structure, and should include, but is not limited to:

A specific testable hypothesis, and

A set of specific aims to test the hypothesis, and

Methods to obtain data to satisfy the aims

A discussion of potential pitfalls and alternative approaches

A timeline for the sequence of experiments proposed.

Reviewers will be asked to place emphasis on the perceived potential of the investigator to make seminal contributions to the field of environmental health science as well as the scientific merit of the research proposal.

Advisory Committee:

The Principal Investigator is strongly encouraged to form an external advisory committee. Names of Advisory Committee members should not be listed in the application. This FOA uses the just in time concept for the External Advisory Committee members. The application should indicate the areas of expertise and scientific and anticipated input, and any critical considerations in the selection of members, at the time of submission. Prior to the interview/funding decision process, the applicant will be requested to name the Advisory Committee members, and ask each potential member to provide a letter outlining his/her expected role and the expertise to be provided to the Principal Investigator’s research and career experiences.

The Advisory Committee is expected to meet at least annually to provide ongoing assessment of the progress of the research, to discuss future research goals, aims, and ideas, and to provide research career guidance to the awardee during the five years of the grant.

NIEHS suggests an Advisory Committee structure such as the following: At least three scientists, two of whom are external to the Department, (one external to the University or Institution). One member should have research expertise to provide input into the toxicant paradigm proposed, and one should be an individual who is expert in human or clinical studies and who can provide input into the translation of the research. A copy of minutes of meetings of the Advisory Committee, provided to the NIEHS perhaps as part of the annual progress report of the grant, will be used by to NIEHS in assessing progress on the individual grants, as well as in evaluating the program as a whole.

Discussion of the Advisory Committee should be included as part of the Field 5, Research and Design and Methods Attachment of the Research Plan.

The Chair of the Department where the Principal Investigator holds the primary academic appointment should provide a letter (attached as a letter of support, Item 16 in the SF 424 (R&R) describing any tangible research support which has been committed to the Principal Investigator. This may include start up packages provided to the investigator, salary commitment, protected time for research, space and equipment allocations, core facilities which will be made available without charge-back, specialized training and mini-sabbatical experiences to promote career enhancement, etc. In addition, the letter should discuss the departmental commitment to protected research time for the applicant. The department is encouraged to provide release time so that the applicant will be able to devote 80% of his/her professional effort to research. (See Section III.3. Other-Special Eligibility Criteria) The strength of the institutional commitment will be considered a factor in the review of the application.

If a previous postdoctoral or research mentor remains in the same Institution as the Principal Investigator, a letter (attached as a letter of support, Item 16 in the SF 424 R&R) should be included in the application which outlines the respective roles of the Principal Investigator and the research mentor in the design and conduct of the proposed research. The research mentor should also indicate how the proposed research program is expected to be independent from the research directions of his/her laboratory.

An applicant who submitted a previous, unsuccessful application in response to RFA-ES-06-007 (ONES) may submit an amended application if he/she still fulfills the eligibility requirements, and if the resubmission application is the selected submission from the School or College. If the application is an resubmission version of an application submitted in response to a previous ONES announcement, applicants should follow the instructions in the SF 424 (R&R)for preparing resubmission applications.

Budget:

Applicants may request up to 5 years of support and $400,000 in direct costs the first and second years and $275,000 in years 3-5. All items must be itemized and justified, i.e., non-modular. The Principal Investigator may request up to $250,000 in direct costs in all five years. These funds will be for research-related expenses. The Principal Investigator is encouraged to budget sufficient travel costs to present the results of the research at a variety of high-caliber technical meetings, at least one of which is devoted directly to research in the environmental health sciences and is widely attended by other NIEHS grantees. In addition, the Principal Investigator may request up to $150,000 per year (direct costs) in years one and two (total direct costs would then equal $400,000), and up to $25,000 per year in years 3-5 (total direct costs would then equal $275,000), for a combination of equipment, resource development, and career enhancement experiences. Equipment or resource development expenses must be justified on the basis of research proposed in the experimental plan or by the long-term research goals in environmental health sciences section of the research plan. Career enhancement activities may include such items as short courses, visits to laboratories of other scientists, Gordon Conferences, and other enrichment activities. This portion of the budget could include travel for external members of the advisory committee to meet yearly and may provide for a consulting fee to members of the advisory committee who are external to the department. In addition, the Principal Investigator should budget for travel to the NIEHS campus in Research Triangle Park each year in years 3-5 to present a seminar or participate in a research symposium.

The Principal Investigator is expected to devote a minimum of 50% effort per year to the grant for the full five-year period.

Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

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.

Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Plan for Sharing Research Data

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

The reasonableness of the data sharing plan or the rationale for not sharing research data may 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.

Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

The 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. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590). See Section VI.3., Reporting.

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 in accordance with the review criteria stated below.

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

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

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.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? What is the anticipated impact of the proposed research on a defined problem in the environmental health sciences, specifically in terms of disease processes relevant to environmental exposure, human biology involved in the cause, prevention, or moderation of disease?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the exposure paradigm and the putative link between the exposure and the relevant human disease realistic and justified? Will the proposed career enhancement activities promote the advancement of the research project and expand the ability of the Principal Investigator to ask important questions?

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

Investigators: Are the PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the Principal Investigator and other researchers? Does the PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)? Can the potential of the investigator to make important research contributions be assessed on the investigator’s future goals and biography sections of the application?

Environment: Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Is the strength of the Institutional support to the career advancement of Principal Investigator evident?

2.A. Additional Review Criteria

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

Resubmission Applications (formerly revised/amended applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R)..

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R)

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the Other Research Plan Sections of the PHS398 Research Plan component of the SF424 (R&R).

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

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Not Applicable

2.D. Sharing Research Resources

NIH policy expects that grant recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

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

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. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each Non-Competing Grant Progress Report (PHS 2590), See Section VI.3., Reporting.

Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information

1. Award Notices

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee 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 Section IV.5., Funding Restrictions.

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 and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

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

1. Scientific/Research Contact(s):

Carol Shreffler, PhD
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 4401, Room 3411
P.O. Box 12233, EC-23,
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Telephone: (919) 541-1445
FAX: (919) 541-5064
Email: [email protected]

2. Peer Review Contact(s):

Janice Allen, PhD
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
79 TW Alexander Drive
Building 4401, Room 3170B
Research Triangle Park NC 27709
Telephone: (919) 541-7556
FAX: (919) 541-2503
Email: [email protected]

3. Financial/Grants Management Contact(s):

Susan Ricci
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 4401, Room 3408
P. O. Box 12233, EC-22
Research Triangle Park NC 27709
Telephone: (919) 316-4666
FAX: (919) 541-2860
Email: [email protected]

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 (45 CFR 46) 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.

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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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 SF424 (R&R) application; 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:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) 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 HHS 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) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

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 RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 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 PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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

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