Part I Overview Information

Department of Health and Human Services

Participating Organizations
Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov/)

Components of Participating Organizations
National Institute for Occupational Safety and Health (NIOSH), (http://www.cdc.gov/niosh/homepage.html)

Title: Centers for Excellence to Promote a Healthier Workforce

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
New

Update: The following updates relating to this announcement have been issued:

Request For Applications (RFA) Number: RFA-OH-05-006

Catalog of Federal Domestic Assistance Number(s)
93.262

Key Dates
Release Date: April 14, 2005
Letters of Intent Receipt Date(s): August 14, 2005
Application Receipt Dates(s): September 14, 2005
Peer Review Date(s): July, 2005
Council Review Date(s): August, 2005
Earliest Anticipated Start Date: September 1, 2005
Additional Information To Be Available Date (Url Activation Date): N/A
Expiration Date: September 15, 2005

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

The National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC), announces the availability of fiscal year (FY) 2005 funds for cooperative agreement (U19) applications from single institutions or consortia of institutions to establish Centers for Excellence to Promote a Healthier Workforce (Centers for Excellence). The purpose of the Centers for Excellence is to establish trans-disciplinary research, education and translation programs to facilitate the integration of health protection and health promotion in the workplace by taking a collaborative and innovative approach.

This cooperative agreement is designed to evaluate and communicate the impact of a comprehensive approach to the health and safety of the nation's workforce. Traditional efforts at protection of the workforce from occupational hazards have been separate from efforts designed to encourage individual choices and behaviors to reduce health risk. Occupational safety and health professionals are generally trained separately from professionals focused on health promotion and behavior change. These groups publish in and access different scientific literatures and attend different professional meetings. This cooperative agreement is intended to promote cooperation between these disciplines in order to optimize approaches to protecting, preserving, and improving the health of people who work. However, NIOSH encourages strong commitment to traditional workplace protection efforts for risk factors that derive from employment.

Improved protection of the health of people who work is a goal shared by workers and their families, employers, and the society as a whole. There is also great interest in controlling the costs, both economic and human, of disease and injury. Nevertheless, there is often uncertainty as to how to proceed in order to accomplish these goals. Workplaces in different sectors and of different sizes may have different needs. Research to define better the elements of healthy workplaces and to understand the impact of and barriers to improved coordination or integration of protection and promotion efforts is needed. As a rule, this research must take place in workplaces. The Centers for Excellence established under this cooperative agreement will work closely with and provide expert consultation to employer-employee partnerships in order to design, implement, and evaluate coordinated or integrated workplace programs and disseminate the results of this work.

Background

The mission of NIOSH is to help assure safe and healthy working conditions for working men and women by providing research, information, education, and training in the field of occupational safety and health. NIOSH provides national and world leadership to prevent work-related illness, injury, disability, and death by gathering information, conducting scientific research, and translating the knowledge gained into products and services. NIOSH's mission is critical to the health and safety of every American worker. As part of its mission, NIOSH has developed the Steps to a Healthier US Workforce Initiative (Steps Initiative; http://www.cdc.gov/niosh/steps/) The NIOSH Steps Initiative came from a broader U.S. Department of Health and Human Services (HHS) initiative called Steps to a Healthier US (http://www.healthierus.gov/steps/) that advances the Healthier US goal of helping Americans live longer, better, and healthier lives. The NIOSH Steps Initiative seeks to improve the dissemination, effectiveness, and acceptance of activities directed at improving worker health through integrated approaches to health protection and health promotion. This effort focuses on 1) preventing work-related illness, injury, and disability, 2) promoting healthy living and lifestyles to reduce and prevent chronic disease and 3) encouraging access to the information, programs, and resources that enable improved prevention of disease and injury for people who work, whether the risk factors derive from inside or outside the workplace.

The NIOSH Steps Initiative is an effort to integrate occupational safety and health protection with health promotion activities into a coordinated system that addresses both workplace and worker health. This initiative strongly supports the view that all illness and injury should be prevented when possible, controlled when necessary, and treated where appropriate. While this initiative is intended to support the integration of these efforts, the funding for health promotion activities is outside the scope of this initiative. Such funding should come from other sources and partnerships.

The health of the U.S. economy depends on a healthy and productive workforce. Yet,

Stress-related disorders also have adverse effects on worker health and productivity. According to the Bureau of Labor Statistics, workers who take time off work because of stress, anxiety or a related disorder will be off work for approximately 20 days.

Lifestyle behaviors around physical activities, nutrition, and tobacco smoking, and substance abuse have a significant impact on people's health. These lifestyle exposures contribute to many diseases including type 2 diabetes, hypertension, heart disease, stroke, and some forms of cancer, and obesity. According to the CDC, each year

These statistics illustrate that investments in preventing occupational and non-occupational illness, injury, and disability experienced by the U.S. workforce can have significant impact on the health-related productivity of American business.

The Steps Initiative creates an opportunity for both the occupational safety and health community and the health promotion community to develop and implement workplace programs collaboratively that prevent workplace illness and injury, promote health, and optimize the health of the U.S. workforce.

Research supported by this program should be able to effectively demonstrate the impact of improved and integrated approaches to health protection and health promotion on the improvement of worker health and safety and define critical elements of health-supportive workplaces.

Objectives

The primary objective of this initiative is to establish Centers for Excellence to Promote a Healthier Workforce that will assess the value of the integration or coordination of health protection and health promotion in the workplace. This will be accomplished by conducting trans-disciplinary research, education and translation projects to determine and communicate the ability of an integrated or coordinated approach to improve the outcome of workplace health protection and promotion programs. Among the areas of emphasis will be the development of measures by which to define health-supportive workplaces and to validate improvement of health, job satisfaction, productivity, and in the control of direct and indirect costs of disease and injury through effective interventions to reduce work-related risk.

A Center for Excellence to Promote a Healthier Workforce will overcome the separation of professionals relevant to workplace health by providing opportunities for dialog, collaboration, and cross-education among the range of disciplines with relevant expertise including many of the following: occupational safety and health, human behavior, economics, business policies and practices, labor education, labor relations, health education, occupational health nursing and medicine, engineering, injury and chronic disease prevention, surveillance, research methods, etc. Centers will provide opportunities for trans-disciplinary educational interactions among students and practicing professionals. Centers will likely promote interactions among existing entities such as Educational Research Centers (ERCs), and programs in business, labor education, economics, human behavior, etc.

Center projects must have relevant partnerships with employers from government, academia, industry, the benefits community or healthcare organizations. Investigators should describe how these partnerships will be established and how each partner will be able to contribute to the research plan without significant impact on employee performance and financial obligations to the grantee.

Applications that will be considered in response to this announcement must address the specific objectives of this cooperative agreement. Below are examples of topics that have been identified as being appropriate for this RFA, but are not limited to:

Social epidemiology research

Methods development research

Efficacy research

Effectiveness research

Dissemination and durability research

While the above topics are appropriate, applicants should be aware that proposed projects should not simply focus on health promotion practices in the workplace, but must embody specific attention to evaluating and ameliorating risk from workplace conditions and exposures.

The essential characteristics of a Center for Excellence cooperative agreement are:

The Center for Excellence cooperative agreement will support broadly based trans-disciplinary exploratory, efficacy, and effectiveness research projects with a strong evaluation component, and education, translation, communication and dissemination projects. A Center for Excellence is expected to have the following components that together address the objectives of a Center:

  1. Administrative, Planning and Outreach Core. This component should NOT exceed $150,000 per year of the direct cost budget.
  2. Trans-Disciplinary Exploratory, Efficacy, and Effectiveness Research Projects. These projects should be at least 45% of the direct cost budget.
  3. Education, Translation, Communication and Dissemination Projects. These projects should be at least 10% of the direct cost budget.

Essential Elements of a Center for Excellence

Administrative and Planning Core (Should not exceed $150,000 of the annual direct costs)

The Administrative, Planning and Outreach Core must have strong leaders committed to the program who are capable of providing scientific leadership for the administration and integration of the program. Assessment of the ability of the program's principal investigator and program staff to lead a highly integrated program of intervention effectiveness research, education and translation projects to reduce work-related health risk, promote health, and prevent disease and injury in the workplace will be a significant consideration in the evaluation of the application.

The Administrative, Planning and Outreach Core supports the administrative and infrastructure costs for the entire program and should not be duplicated within any other components. The responsibilities and activities for this core include:

No more than $100,000 of annual direct costs should be devoted to the activities described above.

1. Provide initial support to develop innovative approaches/lines of investigation in the program areas.

2. Allow exploration of possible innovative new directions representing a significant departure from ongoing funded projects in the Center for Excellence (intervention effectiveness research, education and translation projects).

3. Stimulate investigators from other fields of study to apply their expertise to health protection and health promotion issues.

4. Develop new mechanisms for external or multi-center collaborative partnerships to address integrated or coordinated health protection and health promotion issues.

Trans-Disciplinary Exploratory, Efficacy, and Effectiveness Research Projects (Should be at least 45% of the annual direct costs)

These projects are hypothesis-driven projects focused on improving our understanding of integrated health protection and health promotion issues. The ultimate focus should be on the development, evaluation, validation, and communication of worksite-based programs and approaches intended to improve the health status of people who work in various occupational sectors and in workplaces of various sizes. Research projects should target priority topics including social epidemiology, methods development, efficacy, effectiveness, and dissemination and durability research, and should be done as a part of multi- and trans-disciplinary efforts. These projects are expected to have a well-defined evaluation plan including process and outcome measures to determine the efficiency and effectiveness of the techniques and programs.

Many projects will test promising approaches in actual work settings. Such intervention efficacy and effectiveness projects should be primarily aimed at protecting and maintaining the health status of the workforce and secondarily, at improving health status. Projects may examine the value of systems outside the workplace but with a work relationship such as workers compensation programs, sickness and accident or health insurance benefits, leave policies, return to work approaches, etc. in maintaining or improving health status and preventing adverse impact of workplace or out-of-work health threats.

Education, Translation, Communication and Dissemination Projects (Should be at least 10% of the annual direct costs)

Education projects are projects designed to promote communication and understanding of knowledge and skills to professional students and practicing professionals with a stake in protecting and enhancing the health of people who work and who are or will be involved in the design, implementation, or evaluation of programs, policies, and products intended to protect or improve the health of the workforce.

Translation, communication and dissemination projects are encouraged to translate and deliver the findings from the research of the Center and other relevant research to those in a position to develop and implement improved prevention programs and help overcome barriers to dissemination and adoption of valid approaches to protecting and improving the health of people who work.

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 NIOSH cooperative agreement (U19) 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 NIOSH 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". At this time, it is not known if the RFA will be reissued. Unsuccessful applicants may not submit revised applications to NIOSH.

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.

2. Funds Available

NIOSH intends to commit approximately two million dollars for total costs in FY 2005 to fund one to three new grants in response to this RFA. An applicant may request a project period of up to five (5) years and a budget for direct costs up to one million dollars per year. The earliest anticipated start date for new awards is September 1, 2005 with a project period between September, 2005 and September, 2010.

On July 1 st and November 1 st of each year, the Centers for Excellence will have the opportunity to submit competing supplements for new projects if the requested level of support is under the maximum allowed amount or if additional funds become available.

Because the nature and scope of the proposed project 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 NIOSH provide support for this program, awards pursuant to this funding opportunity are contingent upon the transfer of funds from CDC 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 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-004.html.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

Foreign institutions are not eligible to apply.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed project is invited to work with their 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 NIOSH programs.

Note: Title 2 United States Code section 1611 states that an organization described in section 501 (d) (4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

2. Cost Sharing or Matching

Cost sharing is not required.

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
Only one application per applicant can be submitted under this announcement.

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

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

2. Content and Form of Application Submission

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

The title and number of this funding opportunity must be typed 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

Letter of Intent Receipt Date: August 14, 2005
Application Receipt Date(s): September 14, 2005
Peer Review Date: July, 2005
Council Review Date: August, 2005
Earliest Anticipated Start Date: September 1, 2005

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:

Charles Rafferty, Ph.D. Assistant Director for Review and Policy
Office of Extramural Programs/NIOSH
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2582
FAX: (404) 498-2571
Email: cor9@cdc.gov

3.B. Sending an Application to the NIH

Applications must be prepared using the PHS 398 research grant application instructions and forms as described above. 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)

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Charles Rafferty, Ph.D. Assistant Director for Review and Policy
Office of Extramural Programs/NIOSH
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2582
FAX: (404) 498-2571
Email: cor9@cdc.gov

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf. Personal deliveries of applications are no longer permitted.

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 NIOSH. Incomplete and non-responsive applications will not be reviewed.

CDC/NIOSH 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.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIOSH awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm. Additional guidance may be found at http://grants.nih.gov/grants/policy/policy.htm (see also Section VI.3. Reporting).

Funds relating to the conduct of research will not be released until the appropriate assurances and Institutional Review Board approvals are in place.

6. Other Submission Requirements

For cooperative agreements, awardees must agree to the “Cooperative Agreement Terms and Conditions of Award” in Section VI.2.A of this announcement.

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.

Section V. Application Review Information

1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIOSH. Incomplete and/or non-responsive applications will not be reviewed.

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 NIOSH in accordance with the review criteria stated below.

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

The goals of NIOSH supported research are to reduce work-related illnesses and injuries. 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.

Review Criteria for Overall Program:

1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will workforce health be improved? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that affect workforce health?

2. 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? Is there a plan for meeting the proposed goals including the proposed schedule for initiating and accomplishing each of the activities? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the project fully described and does it include a plan for the dissemination of results? Does the project have a well-developed and conceived evaluation plan? Does the project have appropriate industry/labor and other collaborations? Are projects trans-disciplinary in scope?

3. 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? To what degree does the program design address the distinct characteristics, specific populations, and needs in occupational safety and health?

4. Investigators. Is the leadership ability and scientific stature of the Center Director and his/her ability to meet the program's demands of time and effort adequately described? Are the investigators appropriately trained and well suited to lead a highly integrated program of intervention effectiveness research, education and translation projects to reduce work-related health risk, promote health, and prevent disease and injury in the workplace? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the advisory team contain the appropriate composition? Does the investigative team bring complementary and integrated expertise to the project?

5. 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? What is the degree of interrelationships, collaboration, and synergism of research derived from Center support? Is there a description of how partnerships with employers will be established? Is there evidence of institutional support as evidenced by provisions of appropriate resources, services, technical support, and administrative arrangements and facilities that stimulate collaboration among constituent projects and personnel?

2.A. Additional Review Criteria:

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

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

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

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

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.

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 Principal Investigator will also receive a written critique called a Summary Statement.

If the application is under consideration for funding, NIOSH 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 NOA (Notice of Award) will be provided to the applicant organization. The NOA signed by the grants management officer is the authorizing document.

The Notice of Award will be transmitted by mail and/or e-mail 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 NIOSH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the notice of grant 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 (U 19 ), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIOSH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIOSH 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 NIOSH as defined above.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for coordination of project activities, scientifically and administratively at the awardee institution and at the other sites that may be supported by sub-contractors to this award. The applicant will have primary authority and responsibility to define objectives and approaches; to plan, conduct, and analyze data; and to publish results, interpretations, and conclusions of studies conducted under the terms and conditions of the cooperative agreement award.

Recipient will:

(a) An “Introduction and Summary” of the program.
(b) Director's report of major accomplishments (highlights).
(c) Detailed progress reports on each project, grouped accordingly to type with appropriate references and a list of publications since the last annual report.
(d) A progress report on pilot projects.
(e) A report on the Outreach Program.
(f) A report on specific improvements in occupational safety and health that resulted from center activities.
(g) An administrative report, discussing relevant personnel and other matters.

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. NIOSH Responsibilities

A NIOSH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Additionally, a NIOSH 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

If more than one Center for Excellence is awarded funding, part of this initiative will be the establishment of a Coordinating Committee (CC) that will facilitate sharing of information about activities and accomplishments among the Centers. The CC will also provide leadership and work collaboratively to address occupational safety and health issues at a national level. The CC will be comprised of the principal investigators from the Centers. NIOSH representatives will participate in CC meetings where appropriate but will not have voting privileges. The CC may designate working groups for specific purposes, made up of staff members from their Centers. One such working group could be a Center for Excellence Education Committee. This multi-site committee would provide a means to share data that can potentially be translated to the occupational safety and health community.

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. NIOSH follows this policy.

Awardees will also be expected to submit a comprehensive annual Center report as described in Section VI.2.A.1. of this announcement - Principle Investigator Rights and Responsibilities.

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:

Bridgette E. Garrett, Ph.D.
Office of Extramural Programs/NIOSH
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2508
FAX: (404) 498-2571
Email: bgarrett@cdc.gov

2. Peer Review Contacts:

Charles Rafferty, Ph.D.
Assistant Director for Review and Policy
Office of Extramural Programs/NIOSH
Centers for Disease Control and Prevention
1600 Clifton Road, N.E., MS E-74
Atlanta, GA 30333
Telephone: (404) 498-2582
FAX: (404) 498-2571
Email: cor9@cdc.gov

3. Financial or Grants Management Contacts:

Cynthia Mitchell
Acquisition and Assistance Field Branch
Centers for Disease Control and Prevention
626 Cochrans Mill Road
Pittsburgh, PA 15236-0070
Telephone: (412) 386-6434
FAX: (412) 386- 6429
Email: cmitchell@cdc.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).

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). NIOSH follows this policy.

Sharing Research Data:
Investigators submitting an NIOSH 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.

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. NIOSH follows this policy.

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. NIOSH follows this policy.

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. NIOSH follows this policy.

Public Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public 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 PA 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. NIOSH follows these guidelines.

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. NIOSH follows these guidelines.

URLs in NIOSH Grant Applications or Appendices:
All applications and proposals for NIOSH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIOSH solicitation, Internet addresses (URLs) should not be used to provide information necessary to 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 of Section 20 (a) of the Occupational Safety and Health Act of 1970 (29 USC 669 (a)), 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.

Lobbying Restrictions: Applicants should be aware of restrictions on the use of Health and Human Services (DHHS) funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their subtier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby. In addition, no part of the Center for Disease Control and Prevention (CDC) appropriated funds shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature. Any activity designed to influence action in regard to a particular piece of pending legislation would be considered “lobbying.” That is lobbying for or against pending legislation, as well as indirect or “grass roots: lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies. The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation. It remains permissible to use CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training; and foster safe and healthy environments. Recipients of CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publication, and “grassroots” activities that relate to specific legislation, recipients of CDC funds should give attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

Smoke-Free Workplace:
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.


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