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-05-005, which was previously released on August 9, 2005.

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

Request For Applications (RFA) Number:   RFA-ES-06-007

Catalog of Federal Domestic Assistance Number(s)
93.113

Key Dates
Release Date: July 19, 2006
Letters of Intent Receipt Date(s): November 21, 2006
Application Receipt Date(s): December 21, 2006
Peer Review Date(s): March-April 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date(s): July 1, 2007
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: December 22, 2006

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I. Overview Information

Part II. Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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

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

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

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

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, and infectious or parasitic agents, except when these are disease co-factors to an environmental toxicant exposure to produce the biological effect. Ecologic, biomonitoring, biotransformation 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(s) of Support

This funding opportunity will use the R01 award mechanism.

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

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

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 NIEHS 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.

2. Funds Available

NIEHS intends to commit up to 2.4 million dollars in direct costs ($3.6 million in total costs) in FY 2006 to fund 6 new grants in response to this RFA. 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 RFA again in each of the next two years, contingent on availability of funds.

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

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

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

2. Cost Sharing or Matching

Cost sharing is not required.

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

3. Other-Special Eligibility Criteria

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 1998 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 RFA 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 1 or July 1 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


1. Address to Request Application Information

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

Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

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

3.A. Letter of Intent
Letters of Intent Receipt Date(s): November 21, 2006
Application Receipt Date(s): December 21, 2006
Peer Review Date(s): March-April 2007
Council Review Date(s): May 2007
Earliest Anticipated Start Date: July 1, 2007

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 at the beginning of this document.

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:  Allen9@niehs.nih.gov

3.B. Sending an Application to the NIH

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

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

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

At the time of submission, two (2) additional copies of the application and all copies of the appendix material must 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:  Allen9@niehs.nih.gov

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

3.C. Application Processing

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

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review, unless the applicant withdraws the pending application.  The NIH will not accept any application that is essentially the same as one already reviewed.  This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must include an Introduction addressing the previous critique.

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.

5. Funding Restrictions

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

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 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 continuation 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 NIH Grants Policy Statement http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

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 inserted in the application just prior to the Research Plan. 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:

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:

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 RFA 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.

The Chair of the Department where the Principal Investigator holds the primary academic appointment should provide a letter 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 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-05-005 may submit an amended application if he/she still fulfills the eligibility requirements, and if the amended application is the selected submission from the School or College.   If the application is an amended version of an application submitted in response to a previous ONES announcement, applicants should follow the instructions in the PHS 398 for preparing amended 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. The proposed budget will consist of two parts, both of which 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 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. 

Plan for Sharing Research Data

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

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

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

Section V. Application Review Information


1. Criteria

The following will be considered in making funding decisions:

Other factors which may be considered in selecting applications for award are program balance and the assessed potential of the applicant to advance the research program goals of the NIEHS.  

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIEHS in accordance with the review criteria stated below.

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, 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 investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (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: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is the strength of the Institutional support to the 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:

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

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

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

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

2.B. Additional Review Considerations

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

All items in the Career Enhancement and Equipment/Resource Development Budget will be reviewed by the Initial Review Committee for justification.

2.C. Sharing Research Data

Not applicable

2.D. Sharing Research Resources

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

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

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

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the 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 (http://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm).

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

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Carol Shreffler, PhD
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
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: shreffl1@niehs.nih.gov


2. Peer Review Contacts:

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:  Allen9@niehs.nih.gov

3. Financial or Grants Management Contacts:

Susan Ricci
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P. O. Box 12233, EC-22
Research Triangle Park NC 27709
Telephone: (919) 316-4666
FAX: (919) 541-2860
Email: ricci@niehs.nih.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.

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.

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

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

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

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

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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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