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: Environmental Influences during Windows of Susceptibility in Breast Cancer Risk (U01)

Announcement Type

New

The following updates relating to this announcement have been released:
November 03, 2014 - This RFA has been reissued as RFA-ES-14-012.

Request For Applications (RFA) Number: RFA-ES-09-009

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(s): 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

Purpose. This Funding Opportunity Announcement (FOA) issued by the National Institute of Environmental Health Sciences (NIEHS) and the National Cancer Institute (NCI) solicits cooperative agreement grant applications from institutions to conduct basic laboratory or ancillary research projects involving existing populations or clinical studies focused on gene-environment interactions, as well as the molecular mechanisms engaged, during specific windows of susceptibility that have the potential of modifying a woman’s lifetime risk for developing breast cancer. These activities run in parallel with a limited competition FOA to support ongoing epidemiological investigations as well as a FOA to assume Coordinating Functions for the Breast Cancer and Environment Research Program (BCERP; see RFA-ES-09-008 and RFA-ES-09-010, respectively). The BCERP supports transdisciplinary research on the interactions of environmental factors (including chemical, physical, and social environmental) with genetic factors during windows of susceptibility throughout a woman’s lifespan that potentially influence breast cancer risk. Each research project is required to partner with a local community-based or advocate organization focused on breast cancer as a concern. Community partners will assist with outreach activities to include, but not limited to, translating and communicating research finding to the public and policy makers as well as building and promoting partnerships among researchers, community members, and other engaged stakeholders. The community partners are expected to participate collaboratively with all the members of the BCERP Network, but especially with existing Community Outreach and Translation Cores associated with the ongoing epidemiologic investigations in supporting communication, outreach, and translation of research findings from the BCERP.

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

The Purpose of this FOA (Environmental Influences during Windows of Susceptibility in Breast Cancer Risk) is to invite applications from eligible institutions to participate in laboratory-based and/or research projects involving existing populations or clinical studies investigating the influence of environmental exposures on breast cancer risk. This FOA is being announced in parallel with two other solicitations that together will constitute the Breast Cancer and the Environment Research Program (BCERP) Network. RFA-ES-09-008, Limited Competition: Continuation of Studies on Early Environmental Exposures and Human Puberty (U01), supports ongoing longitudinal studies of early environmental exposure and human puberty previously established through the Breast Cancer and the Environment Research Centers (RFA-ES-03-001). RFA-ES-09-010, Coordinating Center for the Breast Cancer and the Environment Research Program (U01), supports a Coordinating Center to oversee storage, management, and analytical support for data collected in the continued epidemiological studies and facilitate collaboration among researchers, breast cancer advocates, and community partners involved in BCERP projects. Each BCERP grant will involve community engagement. Collectively, the BCERP will form a network of multi-disciplinary teams drawn from the individual research projects that will work collaboratively to conduct high-quality, transdisciplinary research focused on the impacts of environmental exposures on breast cancer risk. The BCERP Network will also develop and implement strategies to translate and communicate these research findings to appropriate stakeholders.

This FOA allows for research studies focused on the use of animal models, in vitro cellular and molecular studies, as well as ancillary research projects involving existing populations or clinical studies. No new recruitment will be supported under this FOA. Rather, the epidemiological, clinical, or population studies involving human subjects should be adjunct, supporting investigations of associations between environmental stressors and the risk of developing breast cancer later in life using, for example, banked biospecimens or collection of other ancillary data. Multiple PI projects are encouraged to promote a multidisciplinary, if not transdisciplinary, approach. Each Window of Susceptibility project is required to include representation from community based/advocate organizations The community partners and the COTCs associated with the limited competition epidemiologic studies will work together to support communication and outreach activities related to the research findings from the BCERP. Representatives from the community partners will also be expected to work collaboratively with members of the COTC and members of parallel research studies on dissemination activities (including a national Key Messages contract) that make up the BCERP Network in supporting the development of key messages resulting from research findings that may be disseminated locally or nationally. Community partners may include, but are not restricted to, community and local religious leaders, representatives of advocacy organizations or departments of health, liaisons to Native American populations, practicing care providers, etc., with a focus on issues related to breast cancer. Research supported through these U01s may not exceed 5 years.

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: a 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.

The current program focused heavily on the pubertal window of susceptibility. This FOA is intended to broaden our impact by studying other plausible time periods. The study of multiple windows is also acceptable.

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)

Research Objectives and Requirements for Environmental Influences During Windows of Susceptibility in Breast Cancer Risk

This FOA supports novel experimental and ancillary epidemiological, clinical, or population studies involving human subjects focusing on the gene environment interactions as well as molecular mechanisms of environmental influences on breast cancer risk operational during relevant windows of susceptibility over the life span of an organism. Research supported by this FOA can entail experiments using animal models appropriate for normal development of the mammary gland, for example, by characterizing the effects of select chemical and/or other environmental stressors (e.g., chemical, physical, nutritional, social) on endpoints such as breast pathology and/or gene and protein expression at critical points in time.

It is expected that research projects proposed in response to this FOA will take advantage of the most currently available and relevant in vitro and in vivo mammary gland biology models, recent technological advances (imaging technologies, various omics approaches and other high-throughput methods), and unique reagents. Human studies also are encouraged; however, recruitment of new subjects to establish or expand an existing cohort is not within the scope of this FOA. The proposed epidemiological, clinical, population projects must be ancillary studies associated with existing epidemiological, clinical or population studies that are uniquely positioned to study windows of susceptibility related to breast cancer risk.

Examples of research areas appropriate for the laboratory-based studies covered by this FOA include, but are not limited to:

It is anticipated that in the course of this work novel biomarkers of normal and altered breast structure and/or function will be developed. The development, validation, and integration of new and enhanced mechanism-based screening paradigms are also encouraged. The choice and/or methods to characterize endpoints of interest will be left to the applicant but may include breast pathology, gene expression, and protein expression profiles of relevant pathways and metabolomic profiles (urine and serum). The goal of this work is to explore scientific hypothesis involved in normal mammary gland development as well as mechanistic actions resulting in toxicologic responses and/or carcinogenesis during these windows of susceptibility.

Examples of research areas appropriate for the epidemiological, clinical, or population studies covered by this FOA include, but are not limited to:

For epidemiology, clinical, or population studies, each application should include specific aims which address leading hypotheses, a description of the existing cohort and basic design of the parent study, sample size calculations for key hypothesis, and methods for collecting additional exposure, health outcome, covariate data, and biological specimens. Applicants should include a justification of how the parent study is uniquely positioned to address hypotheses surrounding the identified window of susceptibility of interest. Inclusion of novel biomarkers of physiological changes in hormone status, breast development, ovarian and hormonal function, as well as research focused on how environmental exposures may explain health disparities in breast cancer incidence, are encouraged as secondary analyses of pre-existing studies. Key areas of expertise for epidemiological, clinical, or population studies include exposure assessment of chemicals and other exposures in biological and environmental media, biostatistics, clinical assessments, clinical laboratory determinations, and genetics, as proposed in their applications. As previously stated, subject and patient recruitment for epidemiologic, clinical, or population studies will not be supported by this FOA.

Successful applicants will function within the Breast Cancer and the Environment Research Program Network. The windows of susceptibility grantees will be expected to contribute to the collective effort by providing new information on the normal growth and development of the breast and reproductive systems, the mechanisms of action related to specific exposures at the sub-cellular, cellular, and organ system levels in animal models and human populations, the impact of environmental stressors on the mammary gland, and the risk of developing breast cancer. Moreover, they will be expected to share with the public and the engaged breast cancer communities, confirmed findings on the relationship between exposures, individual susceptibility, and lifestyle choices on breast cancer risk. Investigators are expected to share their findings with the other BCERP Network participants at annual meetings. Researchers are highly encouraged to engage in bi-directional collaborations, using information derived from the epidemiology-focused efforts to inform the direction of the basic biology. Likewise, information from the biology-based efforts should be evaluated in the context of the epidemiology studies, when feasible.

Community Participation:

Grantees are required to partner with breast cancer advocate(s) and/or members of the engaged community. Applications that do not include collaborative activities among the proposal’s leading research scientist(s) and community partner(s) will be considered non-responsive. Community partners may be community and local religious leaders, representatives of advocacy organizations or health departments, liaisons to Native American populations, practicing health care providers, etc., actively representing breast cancer issues and concerns, and skilled in outreach, education, social work, or public health arenas. The partnership between the research scientists and the community partner are to draw upon the unique strengths that each brings to the partnership. The responsibilities and goals of each of the participants must be clearly described in the application. The partnerships among researchers and community partners are expected to facilitate bi-directional communication between researchers and the engaged community. The community partner must demonstrate that they work specifically on a community-identified concern related to environmental stressors and breast cancer risk. The inclusion of co-investigators with additional expertise, such as a behavioral or social scientist or health care professional engaged with the participating community, is encouraged, if appropriate.

Responsibilities of the research scientist may include, but are not limited to, clarifying what information the proposed study can and cannot provide, summarizing the scientific literature on exposure-related health risks, and interpreting study results in light of the current state of evidence. The research scientists must document in the application the plans and activities to include community partners at appropriate steps of planning the specific aims of the proposal

The types of effort appropriate for community partners includes, but are not restricted to:

Responsibilities of the community partner include, but are not limited to, communicating community concerns regarding environmental exposures of high and relevant importance, representing the community perspective when designing the study to ensure acceptability, and helping to translate and communicate study findings to community members, policy makers and/or other stakeholders, as appropriate. The program should not go beyond public and community education about reducing environmental disease risk. In addition, the community partners are expected to participate collaboratively with other community partners and research projects within the BCERP Network. Their participation will also be sought in the development of Network Key Messages resulting from the breadth of research findings emanating from the Network as a whole, and the community partner may be asked to work with a contractor on this aspect of the project.

Collaborations with community partners are integral to the design and conduct of the research projects supported under this RFA. Support for the community partners should be commensurate with the level of their efforts on the proposed activities and fully justified in the submitted application.

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 up to six awards in response to this announcement. Each award is limited to $300,000 direct costs per year. Applicants may request up to five years.

The estimated amount of funds available for support of the projects awarded as a result of this announcement is $2,700,000 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:

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 Coordinating Center (RFA-ES-09-010) must not be the same PDs/PIs 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) 710-0267, 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.

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

In addition, for applications from foreign organizations:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

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
Letter 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:

Staff Contact
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

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

Researchers, appropriate staff, and community partners are required to participate in the Annual BCERP Network meeting as well as the annual integration meeting and should include funds to cover travel.

Community partners are required to participate in the development of key messages resulting from published research findings.

Research Plan Page Limitations

The research plan, including specific aims, background, preliminary studies and research design and methods sections, should be 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:

Relevance of the proposed project to program priorities. 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?

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

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

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

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

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

Overall assessment of the research-community partnership. Is there evidence of a partnership between research scientist and community members, including evidence that community partners have been involved in formulating research questions? Does the proposed study benefit from unique features of the scientific and community members as a collaborative research team? Is the partnership adequate to ensure success of the proposed project?

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 (PI) will have the primary responsibility for:

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

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

The PI will participate as a member of the Steering Committee.

The PI will comply with Coordinating Center needs, as directed by NIEHS and NCI Program Officials and Staff and the Steering Committee, in monitoring BCERP progress.

The PI will assist the Coordinating Center in compiling for the Steering Committee, necessary monthly and quarterly reports of research activities (including, but not limited to, subject follow-up), meeting summaries, and quarterly research site performance reports.

The PI will fully comply with federal regulatory requirements, including but not limited to those relating to human subjects protections, informed consent, and reporting of adverse events.

The PI will ensure training of study site personnel as needed for standardization of collaborative protocols across sites and for accurate and timely data entry.

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.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

A Steering Committee will serve as the governing board for 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 and one COTC member from each project in 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 & Breast Cancer Risk, the PI of RFA-ES-09-010 - Coordinating Center for the Breast Cancer and the Environment Research Program , 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

Elizabeth A. Maull, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Building 530, Room 3070
P.O. Box 12233 (K3-12)
530 Davis Drive
Morrisville, NC 27560
Telephone: (919) 316-4668
E-mail: maull@niehs.nih.gov

NCI:

Neeraja Sathyamoorthy Ph.D.
Tumor Biology & Metastasis Branch
Division of Cancer Biology
National Cancer Institute
6130 Executive Boulevard EPN Suite 5000
Rockville MD 20850
Telephone: 301-435-1878
FAX: 301-48-0864
Email: sathyamn@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:

Mr. 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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