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)
National Cancer Institute (NCI), (http://www.nci.nih.gov)

Title: Coordinating Center for the Breast Cancer and the Environment Research Program (U01)

Announcement Type

New

Request For Applications (RFA) Number: RFA-ES-09-010

Catalog of Federal Domestic Assistance Number(s)
93.113, 93.393, 93.396, 93.399

Key Dates
Release Date: October 23, 2009
Letters of Intent Receipt Date: November 30, 2009
Application Receipt Date: December 30, 2009  
Peer Review Date: March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 2010 
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: December 31, 2009  

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

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

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

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

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
     A. Cooperative Agreement Terms and Conditions of Award
         1. Principal Investigator Rights and Responsibilities
         2. NIH Responsibilities
         3. Collaborative Responsibilities
         4. Arbitration Process
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

Purpose

This FOA invites applications from eligible institutions to participate as the Coordinating Center for the Breast Cancer and the Environment Research Program (BCERP).

The Coordinating Center will be responsible for facilitating cross-site data collection protocols and overseeing data input, storage, management, standardization/harmonization and sharing for an on-going, multisite epidemiological study (Continuation of Studies on Early Environmental Exposures and Human Puberty); enhancing collaborations among investigators, managing the Steering Committee and its components, managing an advisory Breast Cancer and the Environment Working Group; providing reports on progress and budget to NIH staff; and organizing annual integration and National Meetings of the BCERP. The operations of the Coordinating Center are expected to assist collaborations among multi-disciplinary teams of researchers, breast cancer advocates, and community partners drawn from networks or other collaborative groups to conduct high-quality, transdisciplinary research in the environmental health aspects of breast cancer.

This announcement is one of three that will define the BCERP Network. The other FOAs are “RFA-ES-09-008; Limited Competition: Continuation of Studies on Early Environmental Exposures and Human Puberty (U01)” (web-link 1) and “RFA-ES-09-009, Environmental Influences during Windows of Susceptibility in Breast Cancer Risk (U01)” (web-link 3). Please see each specific FOA for a general description of the overall projects that are expected to work cooperatively.

Background

Recent compelling evidence indicates that Breast Cancer is an environmental disease. While exposures to environmental factors are of intense interest to both researchers and community members, including women with breast cancer, well conducted studies of adult women have revealed little regarding possible environmental causes of breast cancer. The study of “windows of susceptibility” in the etiology of breast cancer is of increasing interest and refers to specific time periods in which breast tissue may be most vulnerable to the effects of environmental exposures and may directly or indirectly affect the risk of developing breast cancer. Specific windows exist when physiologic changes occur in the mammary gland – including gestation, puberty, pregnancy, and lactation - that likely represent time periods of particular susceptibility to environmental factors that may influence breast cancer risk. Thus, research focused on these critical periods of development seeks to improve our understanding of the roles of environmental factors and their interplay with genetic susceptibility.

The Breast Cancer and the Environment Research Centers (RFA-ES-03-001) were established in 2003, following a series of expert workshops and town meetings with the engaged breast cancer community, including the National Breast Cancer Coalition, the National Institute of Environmental Health Sciences and the National Cancer Institute.  The overarching goal of the program was to address gaps in knowledge about the developmental biology of the normal mammary gland and the physiology and genetic regulation of sexual maturation as well as the impact of environmental stressors on these processes. The specific aims were to:

The existing program broadly addressed multiple factors that may influence pubertal onset and long-term risk of breast cancer. As currently structured, the Centers work collaboratively on two projects: n longitudinal epidemiological study examining the environmental determinants of pubertal onset in young girls (“Environmental and Genetic Determinants of Puberty”) and laboratory-based studies using animal and in vitro models to understand underlying biological mechanisms (“Environmental Effects on the Molecular Architecture and Function of the Mammary Gland across the Life span”). In addition, a Community Outreach and Translation Core translated research findings into public health messages for lay audiences as well as policy maker. For a discussion of the Breast Cancer and the Environment Research Centers research questions, a description of the conceptual framework for the etiology of breast cancer, and the rationale for a focus on puberty, see Hiatt RA, Haslam SZ, Osuch J. 2009. The Breast Cancer and the Environment Research Centers: Transdisciplinary research on the role of the environment in breast cancer etiology. Environ Health Perspect doi:10.1289/ehp.0800120. [Online 16 June 2009].

The BCERP has been groundbreaking in its transdisciplinary approaches, methodologies, and practices that utilize multiple forms of expertise including researchers, community members and advocates in an integrated fashion so as to generate new hypotheses and tools. The program optimized involvement of breast cancer advocates and other community partners in the research process to consider the etiology of environmental impact(s) on breast cancer at the genetic, metabolic, and cellular levels, as well as individual, physical and social levels.

Structure of BCERP Network

In the second phase of the BCERP, the aims of the program remain the same. However, the center structure will be separated into its component elements (biology and epidemiology, each with a community partner/COTC) and a coordinating center. All members of the BCERP Network are expected to perform as a transdisciplinary/multidisciplinary network.  Each of the individual research projects are required to have community input to encourage bi-directional communication between the breast cancer advocacy community and researchers as well as to provide outreach activities supporting translation of research findings to their constituencies and policy makers.

To foster cross-project collaborations, members of the BCERP Network will be required to participate in Network interactions including, but not limited to, regularly scheduled face-to-face meetings for the exchange of information among and across research projects, and, where appropriate, subcommittee teleconferences or web-based communications.  Aside from its data coordinating function, the Coordinating Center will facilitate collaborations between and among the research projects and community groups as well as coordinate the Network interactions (face-to-face, teleconferencing, web-based).

Governance of the BCERP Network will be through a Steering Committee comprised of representatives from all funded grants, community partners and COTC members, and the Coordinating Center as well as NIH program staff. One or more subcommittees will be established to coordinate the biology, epidemiology and community partner efforts, as appropriate. (see section, below, on Program Governance)

Coordinating Center Functions and Responsibilities

Core Coordinating functions will include the following:

Activities related to the Continuation of Studies on Early Environmental Exposures and Human Puberty

The Coordinating Center will provide support and assistance to the Study Investigators supported under RFA-ES-09-008, Limited Competition: Continuation of Studies on Early Environmental Exposures and Human Puberty (U01), to accomplish the goals of this initiative and facilitate cross-study activities. However, in general, the Coordination Center will be responsible for the entry, coordination, monitoring, and harmonization of all data collected for cross-site analysis as well as basic analytical support and facilitation of data sharing for cross-site activities. Study investigators will be responsible for the management, and cleaning of data that are specific to their study site (i.e., not part of the cross-site research plan designated by the Epidemiology Subcommittee of the BCERP Steering Committee), storage of biological specimens, and the design and conduct of statistical analyses associated with site-specific research hypotheses.

Coordinating Center applicants should have experience in working as part of a research consortium or other collaborative activities that included clinical/epidemiologic partners.  Examples of the activities the Coordinating Center should be prepared to participate in working with the multi-site epidemiology studies include, but are not limited to the following: 

Meetings and Committees

Applicants must include funds in the requested budget for appropriate Coordinating Center staff to attend the National Conference and Integration meeting at US locations and times to be determined by the Steering Committee and NIH staff.

 Communications

Collaboration Across Studies

Any of the above functions may be performed by the applicant organization or by subcontract to the applicant organization.

Evaluation

The Coordinating Center assists NIEHS and NCI Program Officials and Staff and the Steering Committee in monitoring BCERP progress and will work to ensure data integrity, accuracy, security, and accessibility.

The Coordinating Center is expected to assist in a planned evaluation of the BCER Program and will provide periodic budget and progress reports and scientific updates in user-friendly formats to NIH staff and, if necessary, an independent evaluator. The goal of an evaluation will be to monitor and assess the performance of the BCERP in achieving the goals as indicated in the FOAs. This includes evaluating the quality and innovation of the conducted science as well as assessing critical intermediate indicators of success such as infrastructure development and capacity building; linkages and resource sharing arrangements within and among Centers; and the interdisciplinary and multilevel nature of the research.

BCERP Network Governance

The Steering Committee will serve as the governing board for the BCERP. The Steering Committee will share findings and progress from epidemiologic and mechanistic studies and partnerships; determine the need for redirection in scientific focus in order to accommodate new knowledge and recommend new opportunities and directions for the BCERP. Among its activities, the Steering Committee will share and review annual progress among the components of the BCERP and recommend to NIH activities in need of budget adjustments, novel opportunities for further exploration, research and partnership aims that indicate promise or are lagging in progress, or other priorities that will assist the BCERP program as a whole in reaching its optimal transdisciplinary potential. Though the Steering Committee will make recommendations, NIEHS and NCI Staff will have final approval and all proposed changes and activities must comply with NIH, DHHS, and Federal Guidelines.

Program staff from NIEHS and NCI will manage the BCERP and the Steering Committee, comprised of the Principal Investigator of the Coordinating Center, Principal Investigator and a COTC member from each project in the “Continuing Studies of Early Environmental Exposure and Human Puberty”, and representatives of the supported investigators and community partners of the program, “RFA-ES-09-009; Environmental Influences during Windows of Susceptibility & Breast Cancer Risk,” and NIEHS and NCI program staff.

The Steering Committee will be the guiding entity for the BCERP. In the event that individual project site principal investigators can not reach agreement on critical aspects of the project, such as common protocols, then the Steering Committee, in consultation with NIH Project Staff will make final and binding decisions on how to proceed. However, NIH grantees may also use the arbitration process described below in the case of a disagreement with NIH in scientific or programmatic matters.

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

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the U01 award mechanism.
The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

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

This funding opportunity will use a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

NIEHS and NCI plan to make one award in response to this announcement. Budgets for direct costs of up to $600,000 per year and project duration of up to five years may be requested for a maximum of $3 million direct costs over the project period. Of that, $100,000 per year should be budgeted as a set-aside for an Opportunity Fund that will be used to support cross-site developmental projects.

The estimated amount of funds available for support of the project awarded as a result of this announcement is $900,000 total costs for fiscal year 2010. Future year amounts will depend on annual appropriations.

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 and the receipt of a sufficient number of meritorious applications.

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

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

Foreign institutions are not eligible to apply to this FOA.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach and therefore clearly do not fit the single-PD/PI model. Additional information on the implementation plans, policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a grant with a single PD/PI or multiple PDs/PIs is the responsibility of the investigators and applicant organizations, and should be determined by the scientific goals of the project. Applications for grants with multiple PDs/PIs will require additional information, as outlined in the instructions below. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PDs/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

PDs/PIs for the epidemiologic study (See RFA-ES-09-008) must not be the same PDs/PIs for the Coordinating Center under this FOA but may be members of the same institutions.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Number of Applications. Applicants may submit more than one application, provided they are scientifically distinct.

Resubmissions.  Resubmission applications are not permitted in response to this FOA. 

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

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

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

SPECIAL INSTRUCTIONS

Applications with Multiple PDs/PIs 

When multiple PD/PIs are proposed, use the Face Page-Continued page to provide items 3a – 3h for all PD/PIs. NIH requires one PD/PI be designated as the “contact PD/PI” for all communications between the PD/PIs and the agency. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PD/PIs, but has no special roles or responsibilities within the project team beyond those mentioned above. The contact PD/PI may be changed during the project period. The contact PD/PI should be listed in block 3 of Form Page 1 (the Face Page), with all additional PD/PIs listed on Form Page 1-Continued. When inserting the name of the PD/PI in the header of each application page, use the name of the “Contact PD/PI, et. al.” The contact PD/PI must be from the applicant organization if PD/PIs are from more than one institution.

All individuals designated as PD/PI must be registered in the eRA Commons and must be assigned the PD/PI role in that system (other roles such as SO or IAR will not give the PD/PI the appropriate access to the application records). Each PD/PI must include their respective eRA Commons ID in the eRA Commons User Name field.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership plan approach for the proposed project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” must be included. A rationale for choosing a multiple PD/PI approach should be described. The governance and organizational structure of the leadership team and the research project should be described, and should include communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan. In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award.

Additional information is available in the PHS 398 grant application instructions.

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. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: November 30, 2009
Application Receipt Date: December 30, 2009
Peer Review Date: March 2010
Council Review Date: May 2010
Earliest Anticipated Start Date: July 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 Bass, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 530, Room 3074
P.O. Box 12233, K3-03
530 Davis Drive
Morrisville, NC  27560
Telephone: (919) 541-1307
FAX: (919) 361-4606
Email: bass@niehs.nih.gov

3.B. Sending an Application to the NIH

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

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

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

At the time of submission, two additional copies of the application and all copies of the appendix material (on CD only) must be sent to:

Linda Bass, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 530, Room 3074
P.O. Box 12233, K3-03
530 Davis Drive
Morrisville, NC  27560
Telephone: (919) 541-1307
FAX: (919) 361-4606
Email:  bass@niehs.nih.gov

3.C. Application Processing

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

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

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

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH 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 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/grants/policy/nihgps_2003/NIHGPS_Part6.htm.)

6. Other Submission Requirements

In lieu of a research plan, the following items should be addressed satisfactorily by the applicant:

Evidence of Leadership and Performance Experience

The PD/PI should demonstrate leadership and experience in conducting coordinating functions and in monitoring and evaluating epidemiologic and multi-component projects.

Evidence should be provided demonstrating the applicant’s experience and abilities to:

Evidence of Experience in Organizing Scientific Business Meetings and National Conferences

The Coordinating Center is responsible for supporting infrastructure for meetings and teleconferences. Applicant should have experience arranging logistical services for multi-site studies, such as assuring meetings (e.g., SC meetings) are held and minutes are recorded and communicated to investigators. The PD/PI should demonstrate the organizational skills required to implement a national conference that will disseminate appropriate findings and discussion of modern concepts in breast cancer research to interested investigators, the engaged breast cancer community, and the general public. Evidence should also be presented indicating the PD/PI has the knowledge, skills, and abilities to conduct the necessary business meetings for the BCERP: Steering Committees and sub-committees; the Breast Cancer and the Environment Working Group (composed of independent investigators and advocates), tele-conference, and advanced web-conferences where necessary. A minimum of $100,000 per year should be budgeted for the national conference and integration meetings, in which investigators across the program will share their latest findings with NIH staff and the program at large. NIEHS and NCI recognize that these funds may need to be supplemented by meeting fees, independent sources, or requests to the NIH Institutes.

The application should document:

Capacity and Ability to Manage Data and Communications

The application should document:

completing data entry and verification of study questionnaires and diaries.

Academic and Management Capabilities:

The application should document:

Staffing Expertise and Capabilities:

Departmental and/or Institutional Commitment:

The application should document:

Awardees must agree to the Cooperative Agreement Terms and Conditions of Award in Section VI.2.A.

Applicants must include funds to travel appropriate staff to the Annual BCERP Network meeting (~3 days) and to an integration meeting (~1.5 days) to be held each year at sites to be determined by the Steering Committee and NIH Staff.

Research Plan Page Limitations

The body of the project plans – excluding budget and administrative items - should be described in no more than 25 pages.

Appendix Materials

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

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

Resource Sharing Plan(s)

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

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

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

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

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

Review Process

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

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

The 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?

In addition, specific to this FOA: Will the Coordinating Center facilitate and enhance the BCERP Network’s proposed goals and maximize functioning of the Network as a whole?

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

In addition, specific to this FOA: Are the PD/PI and his/her collaborators appropriately trained and well experienced in the areas of conducting, coordinating and monitoring epidemiologic and multi-component projects; advising and consulting on study design and protocol development; managing and analyzing statistical data? Will this team of investigators contribute unique skills to the overall BCERP Network? Do the applicants have demonstrated experience in working collaboratively with multiple groups, sharing information and working by committee? Are the PD/PI and support personnel adequately trained and qualified for participating and managing multi-institutional collaboration and facilitating and coordinating interaction and communication among investigators and staff from multiple institutions? 

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?

In addition, specific to this FOA: Are new approaches proposed that would streamline research processes, improve communication, collaboration, creativity and performance of the BCERP Network?

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?

In addition, specific to this FOA: Does the application adequately address how each of the required Coordinating Center functions and responsibilities areas responsibility will be accomplished? Are relevant technical problems and their timely and effective solutions adequately addressed? Are the conceptual framework, design, methods, and analyses adequately developed and appropriate to the aims of the proposed research of the BCERP Network? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the plans to respond to requests from Study Investigator, Steering Committee and NIH reasonable and well developed?  

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

In addition, specific to this FOA: Are facilities and equipment for data storage, data security and data analysis appropriate to support the objectives of the BCERP Network? Has the applicant demonstrated adequacy of proposed infrastructure, commitment and documented evidence of institutional support for the proposed endeavor, and institutional support for computer services?  How adequate is the organizational and administrative structure, including the capacity to assure quality control of data, data entry, confidentiality of data, distribution of protocol funds to study sites and proposed plans for day-to-day coordination?

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

Collaborative Strengths. Are there adequate plans for effective interaction and coordination with the other BCERP Network components, the Steering Committee, and the NIH? Do the investigators state their willingness to collaborate and share information among members of the BCERP Network? Do the investigators state their willingness to abide by the priorities and policies agreed upon by the Steering Committee for collaborative studies?

Additional Review Criteria

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

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

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

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

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

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

Additional Review Considerations

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

Applications from Foreign Organizations.  Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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:  1) Data Sharing Plan (http://grants.nih/gov/grants/policy/data_sharing/data_sharing_guidance.htm); 2) 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).

Selection Process

The following will be considered in making funding decisions:

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.

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 Notice of Award 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 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 Notice of Award. 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/grants/policy/nihgps_2003/NIHGPS_Part4.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/grants/policy/nihgps_2003/NIHGPS_part9.htm).

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

2. A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

Overseeing the budget and activities of the Coordinating Center, as detailed, above. The Principal Investigator is expected to cooperate with the BCERP investigators and community partners, and NCI and NIEHS Program Officials and Staff in the design and conduct of protocols, analysis of data, and reporting of results of research undertaken by the BCERP.

The Principal Investigator will agree to accept the participatory and cooperative nature of the collaborative research process.

The Coordinating Center will provide support services to the data collection sites comprising the Continuation of Studies on Early Environmental Exposures and Human Puberty. These services will include establishment and maintenance of a centralized information management system to store, clean, and analyze data that will be used in publications and public presentations of research performed in the three consortia.  The Coordinating Center will serve as a central repository for data on all collaborative projects and provides advice on study design, data collection, data analysis, and publication development.The Coordinating Center prepares, design, and disseminate operations manuals, data collection forms, databases, and results summaries for BCERP projects and protocols;

The Coordinating Center assists NIEHS and NCI Program Officials and Staff and the Steering Committee in monitoring BCERP progress and will work to ensure data integrity, accuracy, security, and accessibility. The Coordinating Center organizes meetings to promote collaboration and for dissemination of findings of interest to the scientific and engaged breast cancer and the environment communities;

The Coordinating Center compiles for the Steering Committee, necessary monthly and quarterly reports of research activities (including, but not limited to, subject enrollment), meeting summaries, quarterly research site performance reports from each data collection site within the Continuation of Studies on Early Environmental Exposures and Human Puberty, and other reports as needed;

Provide, in concert with the NIEHS and NCI Program staff, support necessary to ensure that sites and investigators fully comply with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events;

Provide training for study site personnel as needed for standardization of collaborative protocols across sites and for accurate and timely data entry;

In coordination with NIEHS and NCI Program staff, develop a monitoring plan and provide periodic quality control monitoring at study sites; and

Provide support for regulatory activities, including adverse event reporting, document preparation for IND submissions and other regulatory requirements of domestic or foreign Health Authorities.

Any of the above functions may be performed by the applicant organization or by subcontract to the applicant organization.  

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

2. A.2. NIH Responsibilities
 
One or more NIEHS/NCI Program Officials will be substantially involved the BCERP Network as NIH Project Scientists. NIH Project Scientists will have substantial scientific and programmatic involvement that is above and beyond the normal stewardship role in awards. 

NIEHS/NCI Project Scientist(s) will have the following responsibilities:

In addition to the Project Scientist(s), a designated NIEHS Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.  The NIEHS Program Official may recommend withholding support, suspension, or termination of a U01 award for lack of scientific progress or failure to adhere to policies established by the Steering Committee.

2.A.3. Collaborative Responsibilities
 
A Steering Committee will serve as the governing board for award included in the BCERP Network. The Steering Committee will monitor and assess progress of epidemiologic and mechanistic studies and partnerships; determine the need for redirection in scientific focus in order to accommodate new knowledge and recommend new opportunities and directions for the BCERP.

The Steering Committee will be comprised of the Principal Investigator of the Coordinating Center, the Principal Investigator and one COTC member from each project in the “RFA-ES-09-008 - Continuation of Studies on Early Environmental Exposures and Human Puberty,” representatives of the supported investigators and community partners of the related program “RFA-ES-09-009 - Environmental Influences during Windows of Susceptibility in Breast Cancer Risk,” and NIEHS and NCI program staff. Each represented NIH Institute will have one collective vote. NIH staff can not serve as Steering Committee Chair. Other guidelines for the Steering Committee, such as a quorum, will be determined at its initial meeting.

The Steering Committee will serve as the governing board for the BCERP. The Steering Committee will monitor and assess progress of epidemiologic and mechanistic studies and partnerships; determine the need for redirection in scientific focus in order to accommodate new knowledge and recommend new opportunities and directions for the BCERP. Among its activities, the Steering Committee will share and review annual progress among the components of the BCERP and recommend to NIH activities in need of budget adjustments, novel opportunities for further exploration, research and partnership aims that indicate promise or are lagging in progress, or other priorities that will assist the BCERP program as a whole in reaching its optimal transdisciplinary potential. In the event that individual project site principal investigators can not reach agreement on critical aspects of the project, such as common protocols, then the Steering Committee, in consultation with NIH Program Staff will make final and binding decisions on how to proceed. Though the Steering Committee will make recommendations, NIEHS and NCI Staff will have final approval and all proposed changes and activities must comply with NIH, DHHS, and Federal Guidelines.

Each Steering Committee member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

2.A.4.  Dispute Resolution

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
 
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, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

NIEHS:

Leslie Reinlib, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 530, Room 3072
P.O. Box 12233 (K3-12)
530 Davis Drive
Morrisville, NC  27560
Telephone: (919) 541-4998
E-mail: reinlib@niehs.nih.gov  

NCI:

Gary L. Ellison, Ph.D.
Division of Cancer Control and Population Sciences
National Cancer Institute
Executive Plaza North, Room 5108
6130 Executive Blvd, MSC 7324
Bethesda, MD 20892-7324
Telephone: 301-402-1853
Email: ellisong@mail.nih.gov

2. Peer Review Contacts:

Linda Bass, Ph.D.
Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 530, Room 3074
P.O. Box 12233 (K3-03)
530 Davis Drive
Morrisville, NC  27560
Telephone: (919) 541-1307
FAX: (919) 361-4606
Email:  bass@niehs.nih.gov  

3. Financial or Grants Management Contacts:

NIEHS:

Aaron Nicholas
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 530, Room 3053
P.O. Box 12233 (K3-11)
530 Davis Drive
Morrisville, NC  27560
Telephone: (919) 541-7823
Fax: (301) 451-5334
E-mail: nicholaa@niehs.nih.gov

NCI:

Crystal Wolfrey
Chief
Cancer Control and Population Sciences Grants Branch
National Cancer Institute
6120 Executive Boulevard, Suite 243
Bethesda, MD 20892-7340
Rockville, MD 20852 (for express/courier service)
Telephone: (301) 496-8634

FAX:  (301) 496-8601
Email: wolfreyc@mail.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.

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

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

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/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-09-116.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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html) investigators must submit or have submitted for them their final, peer-reviewed manuscripts that arise from NIH funds and are accepted for publication as of April 7, 2008 to PubMed Central (http://www.pubmedcentral.nih.gov/), to be made publicly available no later than 12 months after publication. As of May 27, 2008, investigators must include the PubMed Central reference number when citing an article in NIH applications, proposals, and progress reports that fall under the policy, and was authored or co-authored by the investigator or arose from the investigator’s NIH award.  For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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

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

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

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

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

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

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


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