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-08-003.

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

Request for Applications (RFA) Number: RFA-ES-09-007

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 (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.113

Key Dates
Release/Posted Date: July 23, 2009
Opening Date:  October 4, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): October 5, 2009
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 Due Date(s):  November 3, 2009
Peer Review Date(s): February – March 2010
Council Review Date(s): May 2010
Earliest Anticipated Start Date(s): July 1, 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: November 4, 2009

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives


Section II. Award Information

1. Mechanism 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. Receipt, 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. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency 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

An essential element of the mission of the National Institute of Environmental Health Sciences  (NIEHS) 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.  Along with these training and career development programs, NIEHS supports an imaginative research program for Early Stage Investigators to identify the best new biomedical investigators and facilitate their establishing a vibrant, independent research program in the environmental health sciences.  It is through this FOA that NIEHS fulfills its mission of insuring a cadre of productive environmental health science investigators for the future.

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 established  a program of R01 research grants intended for researchers who are defined by the NIH as New Investigators and Early Stage Investigators. This program is designed to be highly competitive, and only a limited number are 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.

In addition to the Research Plan components of a  basic  R01 application, submissions to this R01 Funding Opportunity (FOA) announcement:  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)  encourage the 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 specific budget elements devoted to equipment and career enhancement activities.

Research projects proposed in response to this FOA will be expected to have a defined impact on the environmental health sciences and be responsive to both the mission of the NIH and, specifically, to the mission of the NIEHS.  The mission of the NIH is defined as science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability.  The mission of the NIEHS 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 should demonstrate as a rationale for the study a direct and significant endpoint associated with a specific human disease, dysfunction, pathophysiologic condition, or relevant human biologic process; and propose to focus on the human health effect of a toxicant exposure relevant to the mission of the NIEHS. Examples of 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 and environmental monitoring studies, bioaccumulation, environmental engineering or ecologic degradation studies will not be responsive without a significant human exposure biology component. 

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 will be evaluated on a continuing basis by the NIEHS, to assess the impact of the program on the portfolio of the NIEHS, and 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, 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 FOA will use the R01 award mechanism. The Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide). It also uses the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).

Applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component.

2. Funds Available

NIEHS intends to commit up to 2.4 million dollars in direct costs ($3.6 million in total costs) in FY 2010 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 each of the first and second years and $275,000 in each of 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.

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 IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

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

3. Other-Special Eligibility Criteria

Applicants must be designated Early Stage Investigators (ESI) by NIH as defined in NOT-OD-09-013

In addition, 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, 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.

Applicants must have 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.

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.   If his or her ONES application is not chosen for funding, the PI 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 (6 calendar months) and effort to the grant. However, if during the tenure of this grant, should the PD/PI be successful in obtaining funding through another R01 or similar award, the effort on the ONES award may be negotiated with the NIEHS program staff down to no less than 30% (3.6 calendar months). 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.

Resubmissions.    Applicants may submit a resubmission application if they still meet other eligibility criteria and they are the applicant selected from the school.  Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1).  See new NIH policy on resubmission (amended) applications (NOT-OD-09-003, NOT-OD-09-016). Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2).  For these “grandfathered” applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals.  Renewal applications are not permitted in response to this FOA  

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, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

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

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

Several additional separate actions are required before an applicant 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 PDs/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

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 301-435-0714; Email: GrantsInfo@nih.gov.

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. Some fields within the SF424 (R&R) application components, 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: October 4, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s):
October 5, 2009
Application Due Date(s): November 3, 2009
Peer Review Date(s): February – March 2010
Council Review Date(s): May 2010
Earliest Anticipated Start Date(s): July 1, 2010

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:

Linda K. Bass, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
PO Box 12233, K3-03
111 T.W. Alexander Drive
Keystone Building, Room 3074
Research Triangle Park, NC, 27709
Telephone: (919) 541-1307

Fax: (919) 316-4606
Email: bass@niehs.nih.gov 

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 bass@niehs.nih,gov 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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due 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 weekdays (Monday – Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. 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/SO receives the Grants.gov acknowledgments. The AOR/SO and the PD/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 the application status in the Commons.

The NIH will not accept any application in response to this FOA 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. However, the NIH will accept a resubmission application (A1) which was submitted in response to the past year’s FOA, if the PI still meets eligibility criteria and is the application chosen to be submitted for the School,, but such application must include an Introduction addressing the critique from the previous review.  However, applications which have previously been submitted as investigator initiated applications may be submitted to this FOA as new applications if the application and the PI meet the eligibility criteria of the FOA and the application is chosen as submission from the School. 

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 renewal award if such costs: 1) are necessary to conduct the project, and 2) 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 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(s) to fill in his/her Commons User ID in the “PROFILE – 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

Page limitations of the PHS398 Research Plan component must be followed as outlined in the SF424 (R&R) Application Guide. 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:

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 (as Other Attachments, on the 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 a part of the Budget Justification Attachment of the SF424(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 PD/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 the SF424 (R&R) Application Guide 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 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 the minutes of meetings of the Advisory Committee should be provided to the NIEHS as part of the annual progress report of the grant and this will be used by the NIEHS in assessing progress on the individual grants, as well as in evaluating the program as a whole.

The Description of the Advisory Committee should be included as part of Field 5, Research 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 SF424 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 SF424 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-07-005 may apply as a resubmission 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 a resubmission of an application submitted in response to a previous ONES announcement, applicants should follow the instructions in the SF424 for preparing resubmission applications.

Budget:

Applicants may request up to 5 years of support and $400,000 in direct costs for each of the first and second years and $275,000 in each of years 3-5.  All costs 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 to conduct the research project. The Principal Investigator is encouraged to budget sufficient travel costs within this amount to present the results of the research at a variety of high-caliber technical meetings.  At least one of these meetings should be devoted directly to research in the environmental health sciences and be 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 (6 calendar months) per year to the grant for the full five-year period

Appendix Materials

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 comply with the required page limitations may be delayed in the review process.

Resource Sharing Plan(s)

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

(a) Data Sharing Plan: Not Applicable

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

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

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

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

The scientific peer review may include as a part of the second level (NAEHSC) review, an interview/discussion and scientific presentation to a panel consisting of selected members of the NAEHSC, NIEHS Division of Extramural Research and Training Program Staff, NIEHS Division of Intramural Research Scientists, and NIEHS Office of the Director.  The purpose of this interview is to assist the NAEHSC and program staff in making programmatic recommendations to the Director, NIEHS for funding decisions.  The interview and scientific discussion are intended to gain information on the commitment of the applicant to a career in environmental health sciences research, his/her ability for scientific communication in the proposed research area, and plans for long term career development and enhancement. The interview is not intended as an additional scientific review and will not alter the impact/priority score or primary scientific merit review.   

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

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

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

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

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

Investigator(s).  Are the PIs, collaborators, and other researchers well suited to the project?  If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)?  If the project is collaborative or multi-PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Based on the future goals section and the biographical sketch, do the investigator(s) have the potential to make important research discoveries?  

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

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?
If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed? 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? 

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

In addition to the above review criteria, the following criteria will be addressed and considered in the determination of scientific merit and the rating.

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

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

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

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

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

Resubmission Applications.  When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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

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

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

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

Resource Sharing Plans.  Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable:  Sharing Model Organisms (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-042.html); and 3) Genome Wide Association Studies (GWAS) (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html).

3. Anticipated Announcement and Award Dates

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

Awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

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

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 (program), 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
P.O. Box 12233, K3-15
111 T.W. Alexander Drive
Keystone Building, Room, 3018
Research Triangle Park, NC 27709
Telephone: (919) 541-1445
Fax: (919) 541-0462
Email:
shreffl1@niehs.nih.gov

2. Peer Review Contact(s):

Linda K. Bass, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
PO Box 12233, K3-03
111 T.W. Alexander Drive
Keystone Building, Room 3074
Research Triangle Park, NC, 27709
Telephone: (919) 541-1307
Fax (919) 316-4606
Email: bass@niehs.nih.gov 

3. Financial/Grants Management Contact(s):

Lisa Archer Edwards, MBA
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
PO Box 12233, K3
111 T.W. Alexander Drive
Keystone Building, Room 3056
Research Triangle Park, NC  27709
Telephone: (919) 541-0751
Fax:  (301)-451-5334 
Email:  archer@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 (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 institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

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.

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.

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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (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 FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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