Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov/)
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov/)

Components of Participating Organizations
National Institute of Child Health and Human Development (NICHD), (http://www.nichd.nih.gov/)
Office of Behavioral and Social Sciences Research (OBSSR), (http://obssr.od.nih.gov/content)
National Institute on Aging (NIA), (http://www.nia.nih.gov/)
National Institute for Occupational Safety and Health (NIOSH/CDC), (http://www.cdc.gov/niosh/)

Title: Limited Competition for Evaluating the Health Benefits of Workplace Policies and Practices Phase II (U01)

Announcement Type
This is a renewal of RFA-HD-04-017 which was previously published September 24, 2004

Request For Applications (RFA) Number: RFA-HD-07-101

Catalog of Federal Domestic Assistance Number(s)
93.865, 93.866, 93.262

Key Dates
Release Date: November 27, 2007
Letters of Intent Receipt Date: December 28, 2007
Application Receipt Date: January 29, 2008
Peer Review Date: June 2008
Council Review Date: October 2008
Earliest Anticipated Start Date: September 15, 2008
Expiration Date: January 30, 2008

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 and Review and Anticipated Start Dates
1. Letter of Intent
B. Sending an Application to the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

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

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

This funding announcement will allow the Work, Family, and Health Network (hereafter referred to as WFHN or the Network ) the opportunity to proceed to an implementation and evaluation phase. In the initial developmental phase, network members conducted pilot studies and interdisciplinary projects to develop a workplace intervention in response to RFA-HD-04-017, Developing Studies Designs to Evaluate the Benefits of Workplace Policies and Practices. In Phase II, network members will implement a workplace intervention aimed at reducing work-family conflict and evaluate the health benefits for workers, workers families and children/dependents, and the employers places of business.

Background

Balancing work and family responsibilities is a frequent source of stress and strain which affects the individual, family, and workplace. In the scientific literature, this experience is generally termed work-family conflict. Work-family conflict may generate spillover, where negative consequences follow the employee from the workplace into the home, and crossover effects, where negative consequences spread from the employee to other employees in the workplace or family members (including spouses, dependent children, and adult care recipients, such as aging parents or disabled spouses) in the affected home.

It is important to understand how the multifaceted pressures of work and family form an environmental context influencing health and well-being among employees and their family members. Previous research demonstrates that control over one’s schedule and supportive supervisors are associated with lower levels of work-family conflict, but the literature does not provide evidence about how organizations can facilitate schedule control and supervisor support. Workplaces may or may not choose to provide policies to assist workers as they attempt to simultaneously handle their family and work responsibilities, and policies that exist on the books may not be accessible or may be implemented unevenly. Epidemiological evidence suggests that job and family demands each have important effects on health, but understanding their complex interactions goes beyond any single research paradigm and requires interdisciplinary theory-building and methodological development. Strategies to alleviate work-family conflicts will thus require innovative, interdisciplinary solutions.

The toll of work-family conflict has received increasing attention recently in the popular press, particularly in magazines aimed at businesses, work-life professionals, and employed parents and family caregivers. Articles in scientific journals have suggested links between working conditions and health-relevant outcomes such as stress, sleep, and parents success in scheduling health care appointments for family members. State and federal governments in Australia and the United Kingdom have established the right to request a flexible schedule in order to care for dependents. In the United States, flextime was the subject of a recent GAO report with associated testimony to Congress (http://jec.senate.gov/hearings.htm#061407). One goal of this program is to support high-quality research in the area of strategic interventions so that these public discussions can be informed by a solid scientific base of evidence.

Types of Research and Approaches Sought

Proposals responsive to this FOA should detail a specific workplace intervention protocol designed to ameliorate work-family conflict experienced by employees and address worker, family, and employer health and concerns. This intervention should involve both employees and their supervisors, and it should address both the social/temporal organization of work and the organizational culture of the workplace. The intervention proposed should allow for adaptability to the needs of different types of workers and workplaces, but the investigators should discuss plans to retain conceptual fidelity across sites.

Studies should conceptualize a mediational link between the amelioration of work-family conflict by this intervention and health outcomes. Health outcomes should be examined for multiple stakeholders: workers, their families and children/dependents, and employers. Relevant health outcomes for individual workers include self-reported health, health behaviors, known pre-disease pathways for chronic conditions, indicators of stress, and safety/injuries. Relevant outcomes for crossover effects to workers family members include pre-disease pathways, hormonal stress indicators, and family interpersonal processes. Assessments of health outcomes for the workplaces involved may include productivity, absenteeism, retention, rates of accidental injury, and crossover effects within work groups, in addition to the employers likely return on investment.

Proposals should also include a sustainability/translation component, in which the Network will continue to work with the Employer and Employee Advisory Committees, as well as communicate with other business and lay groups. This community participation will ensure the realistic and feasible nature of the intervention development and implementation and the relevance of the evaluation conducted. The ultimate goal of this Network is that the results of the research and the methodologies developed will eventually be accessible and informative to employers and employees for their own use in the implementation of work-family policy interventions.

The next phase of the Network will implement and evaluate a workplace intervention for which preliminary studies demonstrate evidence of improving work-family conflict and employee health. The intervention will address control of the daily work process and the culture in which supervisors and their reports interact. The intervention will target multiple levels of organization in the workplace. The study design will allow for randomization at the group level, with treatment and control groups. The Network will study businesses in two industries to allow for variation in the level of professionalization of workers and economic constraints facing employers, and to improve the perceived replicability of the findings. Within each industry, the Network will recruit enough worksites and employees per worksite to power hypotheses delineating the main effect of the intervention. The presence of spillover and crossover effects should be evaluated. Outcomes will include indicators of worker health (e.g., blood pressure, sleep quality), family and child health (e.g., spousal relationships, children’s stress), and employer health (e.g., productivity, absenteeism). Adhering to the standards of true external validity (e.g., random sampling to obtain a representative sample of workplaces) in not possible within the constraints of this project, so the study design should focus on internal validity with an eye to producing an intervention and evaluation methodology with the potential to be replicable across a range of workplace situations and worker populations.

Researchers will collect data from multiple respondents worker, employer, spouse, and child or other relevant dependents. Data will be collected using multiple methods, at multiple levels of the organization and across multiple points in time. The Network will conduct primary data collection with both treatment and control workers in their places of employment. The Network will also collect data from a subset of treatment workers and their family members in the home. Data collection components may include on-line surveys, interviews (in person and/or by telephone), and both objective and self-report indicators of health outcomes. With employer cooperation, the Network will take advantage of administrative sources of outcomes data that companies already collect, such as retention and productivity measures.

The intervention and evaluation should include baseline and follow-up interviews. Collection of biological specimens and objective health indicators (e.g., salivary hormones, blood spots, sleep duration, blood pressure, and height and weight) and gathering of relevant administrative records should also occur at appropriate intervals. Researchers will interview/survey respondents in languages other than English if necessary. Researchers will test the efficacy of the intervention in a population-based model and will also examine individual trajectories in substudies of specific workers and family members. Research plans will also address diversity among workers along the lines of race, ethnicity, nativity, family structure, and gender. The evaluation will include measures of implementation to assess at what level the intervention was actually implemented and utilized.

The intervention must be framed for each workplace as taking into account the existing conditions for the specific firm and not present a standardized package imposed without tailoring. Therefore, implementation will require walking a careful line between customization and the maintenance of fidelity across sites. Previous efforts in dissemination research have often assumed that interventions can be transferred into any service setting without modification and that a unidirectional flow of information (e.g., publishing a guideline) is sufficient to achieve practice change. "Success" of the transfer has been largely assessed based on structural measures (such as counts of training sessions provided or average duration of time per employee spent attending sessions) or recipient outcome measures that do not specifically assess how the intervention was implemented or whether the implementation remained faithful to the original conceptualization and intent of the intervention. Collecting information for a process evaluation will be part of the Phase II data collection.

Applicants should present a unified vision of the work to be undertaken in Phase II. Applicants should provide considerable evidence of preliminary studies contributing to the feasibility of the overall project. The initial hypothesis of this initiative, that work-family conflict impacts health, has been demonstrated through the preliminary work done in Phase I and thus should be described. Additionally, applicants should demonstrate their ability to work collaboratively within their own proposed research team, with the larger Network, and as a partner with the Federal Government in a cooperative agreement mechanism. Relevant areas of scientific expertise required by the interdisciplinary nature of this project should be covered across the entirety of the investigative teams.

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

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the U01 award mechanism(s).

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

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

The NIH U01 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator 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". Plans beyond the current funding opportunity are indefinite.

2. Funds Available

The participating ICs and agencies, NICHD, OBSSR, NIA, and NIOSH, intend to commit approximately 5.8 million dollars in FY 2008 to fund up to six competing continuation grants in response to this RFA. Applicants should request a project period of five years and should request support appropriate to the fulfillment of the responsibilities of their role in the Network (RU, DCC, or TCC). The earliest anticipated start date is September 15, 2008.

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 ICs and agencies 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.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

Applications may only be submitted by currently-supported investigative teams of the Work, Family, and Health Network. Individual investigators may submit only one application, but a given application may involve multiple sites, including other WFHN grantees and partners.

Eligible institutions may include;

1.B. Eligible Individuals

The principal investigator of each application must possess the skills, knowledge, resources, and professional experience needed to carry out the proposed research and research capacity development goals and objectives of the Work, Family, and Health Network. In addition, they should have an established productive, working relationship as scientific collaborators.

The applicant(s) will be solely responsible for planning, directing, and executing the proposed project. Individuals from underrepresented racial and ethnic groups

2. Cost Sharing or Matching

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

The most current Grants Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing

3. Other-Special Eligibility Criteria

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 on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

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

3.A. Receipt, Review and Anticipated Start Dates
Letters of Intent Receipt Date: December 28, 2007
Application Receipt Date: January 29, 2008
Peer Review Date: June 2008
Council Review Date: October 2008
Earliest Anticipated Start Date: September 15, 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Jeff Evans, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8B07, MSC 7510
Bethesda, MD 20892-7510
(Rockville, MD 20852 for courier or express service)
Telephone: (301) 496-1176
Fax: 301-496-0962
Email: evansvj@mail.nih.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and five 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).

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

3.C. Application Processing

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

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial 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 and HHS awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statements can be found at http://grants.nih.gov/grants/policy/policy.htm and http://www.hhs.gov/grantsnet/adminis/gpd/.

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements

Collaborative Arrangements

The grantees will form a scientific partnership with NICHD, OBSSR, NIA, and NIOSH to implement and evaluate organizational policy, practice, and process interventions in workplace settings. Evidence of prior collaboration and a plan for proposed collaborations between the investigators and proposed access to relevant workplaces must be provided. The application must provide details of agreements regarding sub-contracting arrangements and the approach to conducting the team science effort, through its description of: the roles and areas of responsibility of participating scientists, the process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, procedures for resolving conflicts, and other information related to the management of the proposed project in order to demonstrate the potential effectiveness of such collaboration for the ongoing work of the Network.

Meetings

Grantees and federal staff may meet up to four times per year, usually in the Washington, D.C. area. The PI should include funds in the proposed budget for attendance at these meetings. The budget request may also include funds for up to four trips per year for other members of their research team to attend key meetings. Each meeting will be approximately two days in length.

Center Structure and Requirements

The WFHN shall have three types of components: four Research Units (RUs), one Data Coordinating Center (DCC), and one Translation Coordinating Center (TCC). The PIs of all Centers shall have equal rights and responsibilities within the governance framework of the Network.

Research Units (as a group) shall:

The Data Coordinating Center shall:

The Translation Coordinating Center shall:

Required Application Components

Applications submitted in response to this RFA should indicate whether the applicant is applying for the role of RU, DCC, or TCC. Applicants for RU and DCC grants should provide a description of the proposed intervention and evaluation in Section D. Research Design and Methods. Applicants for the TCC should substitute a description of their plans to fulfill responsibilities for translation, dissemination, and logistics.

Plan for Sharing Research Data

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

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

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

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.

RU applicants may propose to oversee intervention worksites, analyze health outcomes, and/or conduct substudies in specific populations, as appropriate to their expertise. In any case, the research proposed should be integral to the goals of the Network.

The following will be considered in making funding decisions:

2. Review and Selection Process

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

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

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventive interventions that drive this field? Will this study advance knowledge of the impacts of work-family conflict and interventions to ameliorate it on stakeholders: workers, their families and children/dependents, and employers?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the approach well-grounded in the preliminary studies presented? Will the study have internal validity?

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

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Research Unit Applicants

Evidence of successful past performance: Does the applicant demonstrate high quality prior experience in the design, conduct, and data analysis of research projects and with collecting data in workplaces or from workers family members outside the workplace? Has the applicant performed successfully as a collaborator in Phase I network activities?

Qualifications and commitment of key personnel:

Does the applicant present an effective plan to cooperate in all Network functions? Does the applicant present an effective plan for internal leadership and collaboration? Does the applicant propose appropriate commitment of staff time for the satisfactory conduct of Network activities? Are the described capabilities to fulfill the responsibilities proposed for this Research Unit in concert with the other investigative teams adequate?

Data Coordinating Center

Evidence of successful past performance: Does the applicant demonstrate high quality prior experience in the design, conduct, data collection, data analysis, and data management of major research projects? Has the applicant performed successfully as a collaborator in Phase I network activities?

Qualifications and commitment of key personnel:

Does the Principal Investigator present an effective plan to cooperate in all Network functions? Does the application demonstrate appropriate expertise and capability in statistics, econometrics, study design, development and support, as well as data analysis, project management, staff site training, and quality assurance procedures? Does the applicant propose appropriate commitment of staff time for the satisfactory conduct of Network activities?

Evidence of management capability: Does the applicant demonstrate the ability to estimate appropriate and reasonable resources for research studies? Does the applicant demonstrate the ability to manage research resources efficiently during study execution? Does the applicant demonstrate the ability to enhance collaboration among Research Units of the Network?

Translation Coordinating Center

Evidence of successful past performance: Does the applicant demonstrate high quality prior experience in the design, conduct, and dissemination of findings from major research projects? Has the applicant performed successfully as a collaborator in Phase I network activities?

Qualifications and commitment of key personnel:

Does the Principal Investigator present an effective plan to cooperate in all Network functions? Does the applicant demonstrate appropriate expertise and capability in communicating research findings to non-academic audiences, and in creating and maintaining relationships between non-academic stakeholders and researchers, and in the science of translation? Does the applicant propose appropriate commitment of staff time for the satisfactory conduct of Network activities?

Evidence of management capability: Does the applicant demonstrate the ability to balance the competing and coinciding needs of the research and business communities in joint efforts? Does the applicant demonstrate the ability to manage communication and logistical resources efficiently across the Network and all components (e.g., Steering Committee, Advisory Boards)? Does the applicant demonstrate the ability to enhance collaboration among Research Units of the Network?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

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

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

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

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing. Program staff will be responsible for the administrative review of the plan for sharing research data.

2.D. Sharing Research Resources

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

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

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

3. Anticipated Announcement and Award Dates

Not applicable

Section VI. Award Administration Information

1. Award Notices

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 12 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/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). See also Part II Terms and Conditions of HHS Grant Awards (http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc).

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 U01, 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

Each PI and his or her investigative team will have primary responsibility to carry out their portion of the intervention, as described in their proposal.

Each investigator will have the right to publish results from their individual research programs from Phase I, but they should collaborate with the Steering Committee and the Translation Coordinating Center to ensure that relevant findings are communicated to the Network and to other interested parties. Due publication credit will be given to all work done cooperatively from Phase I and in Phase II.

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

A NICHD Program Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. Program staff from the co-sponsoring NIH ICs also will be involved in the WFHN program, primarily as Staff Science Collaborators.

NICHD Staff Involvement: Program Scientist and Project Officer

NICHD Program Scientist

The NICHD Program Scientist will serve as the principal representative of NICHD and NIH and will have substantial programmatic and scientific involvement that is above and beyond the normal stewardship role in awards and will, in consultation with relevant NICHD program staff and representatives of the other NIH co-sponsors, provide overall programmatic oversight, coordination, and assistance to the Network.

Specifically, the NICHD Program Scientist will:

NICHD Project Officer

Additionally, a NICHD Project Officer will be responsible for the normal scientific and traditional programmatic stewardship of the cooperative agreement award and will be named in the award notice. This role is separate from the Program Scientist and will include the following:

NIH Staff Science Collaborators

Program representatives of the other NIH co-sponsors may serve as Staff Science Collaborators to the Network. They may participate in Steering Committee meetings as non-voting members. Specifically, the NIH Staff Science Collaborators will:

2.A.3 CDC/NIOSH Responsibilities

CDC/NIOSH Staff Involvement: Program Official and Staff Science Collaborator CDC NIOSH Program Official

A NIOSH Program Official will be responsible for the normal scientific and traditional programmatic stewardship of the cooperative agreement award(s) administered by CDC/NIOSH and will be named in the award notice. This role will include the following:

CDC/ NIOSH Staff Science Collaborator

A NIOSH intramural scientist may serve as a Staff Science Collaborator to the Network and may participate in Steering Committee meetings as a non-voting member. Specifically, the NIOSH Staff Science Collaborator will:

The NIOSH Staff Science Collaborator will not be involved in evaluation of the progress of the award or Extramural Program decisions affecting the award.

2.A.4. Collaborative Responsibilities

In addition to the above specified rights, responsibilities, and involvement, the WFHN components have collaborative responsibilities. These include interaction with the Advisory Boards and membership on the Steering Committee.

Steering Committee

The Steering Committee will serve as the Network's central point of communication; exchange of ideas; development, review and management of common protocols; research and training activities; and problem resolution. The Steering Committee, through the Publication Subcommittee, reviews all collaborative presentations and publications. The Steering Committee is composed of the PI of each Research Unit, the PI of the Data Coordinating Center, the PI of the Translation Coordinating Center, and the NICHD Program Scientist, each of whom have one vote. The Steering Committee will elect a Chair or Co-Chairs on an annual basis; in the case of a tie, the vote of the NICHD Project Scientist will not count. Representatives of other NIH and CDC co-sponsoring Institutes and Centers (ICs) may participate as non-voting members.

The Steering Committee will meet quarterly in person and will participate in telephone or video conferences as needed between Steering Committee meetings. The PI should plan to attend these meetings and may also plan for up to six trips per year for other members of their research team to attend key meetings or research conferences. Each Steering Committee meeting will be approximately two days in length. During the meetings, the Steering Committee will discuss research progress and problems for each site, refine common theoretical and analytic approaches and the research design, and discuss the implications of their research with interested parties outside of the Network who may be invited by the Steering Committee as warranted. Subcommittees will participate in face-to-face meetings and conference calls as needed.

The Steering Committee members will:

B. Employer and Employee/Union Advisory Committees

The TCC will be responsible for maintaining and communicating with these advisory bodies and for representing their interests to the Steering Committee. These advisory bodies will review proposed research plans, comment upon their feasibility and practical importance, assist in the implementation of research where appropriate, and carry out other activities determined by the Steering Committee.

2.A.5. Arbitration Process

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. An Arbitration 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 arbitration procedure in no way affects 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 PHS Non-Competing Grant Progress Report, Form 2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm) and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

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

1. Scientific/Research Contacts:

Jeff Evans, Ph.D.
Demographic and Behavioral Sciences Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8B07, MSC 7510
Bethesda, MD 20892
Telephone: (301) 496-1176
Fax: 301-496-0962
Email: evansvj@mail.nih.gov

Bernadine B. Kuchinski, Ph.D.
National Institute for Occupational Safety and Health
Office of Extramural Programs
4676 Columbia Parkway, Room 152
Cincinnati, OH 45226
Telephone: (513) 533-8511
Fax: (513) 533-8564
Email: bkuchinski@cdc.gov and please copy oepcorrespond@cdc.gov

Lis Nielsen, Ph.D.
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Ave., #533
Bethesda, MD 20892-9205
Telephone: (301) 402-4156
Fax: (301) 402-0051
Email: nielsenli@nia.nih.gov

2. Peer Review Contacts:

Valerie L. Durrant, Ph.D.
Scientific Review Officer
Health of the Population (HOP) Integrated Review Group
Center for Scientific Review, NIH
6701 Rockledge Drive, Room 3140, MSC 7770
Bethesda, MD 20892-7770 (20817 for Fed Ex/delivery)
Telephone: 301-435-3554
Fax: 301-480-1056
Email: durrantv@csr.nih.gov

3. Financial or Grants Management Contacts:

Robin Kurtz
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 8A01, MSC 7510
Bethesda, MD 20892
Telephone: (301) 435-6978
Fax: (301) 451-5510
Email: rkurtz@mail.nih.gov

Richard Proper
Grants and Contracts Management Office
National Institute on Aging
7201 Wisconsin Ave., #2N/212
Bethesda, MD 20892-N9205
Telephone: (301) 402-7735
Fax (301) 402-3672
Email: properr@nia.nih.gov

Section VIII. Other Information

Required Federal Citations

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).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

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

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.

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

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

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

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

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