and Human Services (HHS)
EXPIRED
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)
Title: Centers of
Excellence to Promote a Healthier Workforce (U19)
NIH is not participating in this
announcement. The policies, guidelines, terms, and conditions of the HHS
Centers for Disease Control and Prevention (CDC) stated in this funding
opportunity announcement (FOA) might differ from those used by the HHS National
Institutes of Health (NIH). If written guidance for completing this application
is not available on the CDC website, then CDC will direct applicants elsewhere
for that information.
Authority: This program is described in the Catalog of
Federal Domestic Assistance 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 the Occupational Safety and Health Act of 1970, Section 20(a)
and 21(a) (29 USC 669(a) and 29 USC 670), Federal Mine Safety and Health Act,
Section 501(a), 30 USC 951 (a); Section 301 of the Public Health Service Act as
amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the HHS Grants Policy Statement.
Announcement
Type
This
is a reissue of RFA-OH-05-006.
Update: The following update relating to this announcement has been issued:
NOTICE: Applications submitted in response to this Funding Opportunity
Announcement (FOA) for Federal assistance must be submitted in paper format. Application materials may be obtained from http://grants.nih.gov/grants/funding/phs398/phs398.html.
Catalog
of Federal Domestic Assistance Number(s)
93.262
Key Dates
Release Date: October 26, 2010
Letters of Intent
Receipt Date(s): (Extended to December 15, 2010 per NOT-OH-11-001), Original Date: November 15, 2010
Application Receipt Dates(s): (Extended to January 28, 2011 per NOT-OH-11-001), Original Date: December 17,
2010
Peer Review Date(s): March
2011
Council Review Date(s): May,
2011
Earliest Anticipated Start Date: August 2011
Additional
Information to Be Available Date (URL Activation Date): Not applicable
Expiration Date: (Extended to January 29, 2011 per NOT-OH-11-001), Original Date:December 18, 2010
Due Dates for E.O. 12372
Not Applicable
Additional
Overview Content
Executive Summary
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. Address to Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt, Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application
C. Application Processing
D. Application Assignment
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection Process
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. NIOSH
Responsibilities
3.
Collaborative Responsibilities
4. Dispute
Resolution 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
Background
Since the passage of the Occupational Safety and Health Act in 1970, the mission of NIOSH has been the protection of worker safety and health. This is accomplished by conducting research and providing information, education and training to assure safe and healthful working conditions for American workers. Workplace injury data from the Bureau of Labor Statistics indicates that 4,340 fatal injuries occurred in 2009, down from 5,214 in the previous year. The fatal injury rate was 3.3 per 100,000 workers. Annually, 49,000 deaths are attributed to work-related illnesses. In 2008, 4.6 million U.S. workers sustained either a non-fatal occupational injury or illness. Work-related injuries, illnesses and deaths are very costly to American society. Workers compensation costs sustained by employers and insurers, which represent only a portion of total costs, totaled $85 billion in 2007 (MMWR Workers Memorial Day-April 28, 2010) Although US worksites appear to be becoming safer, the toll of workplace injuries and illnesses is still significant, presenting a burden to workers, their families and the nation. To carry out the mandate of the Act, in 1996, NIOSH launched the National Occupational Research Agenda (NORA) which sets priorities for health and safety research, and followed up in 2006 with a focus on eight NORA industrial sectors and twenty four cross sectors organized around adverse health outcomes, statutory programs and global efforts. This partnership program is intended to stimulate innovative research, improve workplace practices and guide NIOSH in carrying out its mandate.
The Steps to a Healthier Workforce Initiative was launched by NIOSH in 2003. In 2004, NIOSH and a number of partners co-sponsored a national symposium, Steps to a Healthier US Workforce, to explore the science and economics of integrated work-based approaches to protect workers, promote worker health, and to discuss the current state of practice. The following link provides more information on these efforts http://www.cdc.gov/niosh/worklife/steps/2004/default.htm
Following that symposium, NIOSH was strongly encouraged to continue to explore the benefits of integrated programs to improve worker health and well being. As a result, WorkLife became part of the NIOSH program portfolio and aimed to decrease disease, increase effectiveness and focus activities on improving worker health through integrated approaches to health protection and health promotion. The focus was on the need to reduce risks not only from worksite hazards but also from the burden of chronic diseases sweeping the country, such as, cancer, cardiovascular disease, diabetes, obesity and tobacco use. In 2005, the Steps program became the NIOSH WorkLife Initiative and followed up in later years with another symposium, WorkLife 2007: Protecting and Promoting Worker Health.
The WorkLife Program, now an active part of the NIOSH NORA priority areas for research, emphasizes the promotion of workplace programs, policies and practices that result in healthier more productive employees through a focus on disease prevention, health promotion and accommodation to age, family and life stage. A key part of the Program is Essential Elements of Effective Workplace Programs and Policies for Improving Worker Health and Wellbeing.
It is intended to be a resource document and a guide for employers and employer-employee partnerships wishing to establish effective workplace programs that improve and sustain employee health. It identifies twenty components of a comprehensive work based health protection and health promotion program categorized into four areas: Organizational Culture and Leadership; Program Design; Program Implementation and Resources; and, Program Evaluation.
In order to build on the NIOSH WorkLife Program, NIOSH published an FOA in 2005, Centers for Excellence to Promote a Healthier Workforce, inviting applications to establish Centers that would conduct transdisciplinary research and education and translation programs to facilitate the integration of health protection and health promotion in the workplace. Two Centers were awarded funding in 2005, the Healthier Workforce Center for Excellence at the University of Iowa and the Center for Promotion of Health in the New England Workplace at the University of Massachusetts/Lowell. The following year a third Center, the Healthier Workforce Center for Excellence, was funded at Harvard University.
Over the past decade, there has been increasing support nationwide for the American public to increase healthy lifestyles because of their impact on the health of individuals. As a result, health promotion programs have proliferated in the country, including some at worksites, but not without challenges concerning employer commitment and cost-effectiveness. There have also been concerns raised about the primary responsibility of employers being the protection of workers from hazardous working conditions while health promotion activities focus on individual behaviors and reduction of non-occupational risks.
Recently, however, the occupational health community and health care leaders are discovering that an integrated approach to keeping workers healthy by reducing risk of chronic diseases through health promotion activities, while also protecting workers from hazardous work conditions, not only produces healthy productive workers but also benefits employers by reducing their health care costs and costs of conducting business.
Federal agencies and public and private sector groups have collaborated in developing initiatives to deal with health promotion concerns in communities as well as at the worksite. The CDC promotes community programs that target chronic diseases and participates in tracking the Healthy People 2010 Objectives which address health promotion in workplace settings. It concludes that optimally, worksite health promotion efforts should be part of a comprehensive occupational safety and health program.
In 2009, the American Heart Association published a Policy Statement Worksite Wellness Programs for Cardiovascular Disease Prevention. Justifying the need for CVD and stroke prevention activities at the worksite, it noted that an estimated 25% -30% of companies medical costs per year are spent on employees with the major risk factors of smoking, obesity, hypertension, diabetes and physical inactivity. It concludes that environmental modifications should promote healthy behaviors while minimizing the physical and organizational risks at the worksite. The Statement further recommends that wellness programs address the needs of all employees, particularly blue collar workers, workers of different races and ethnicity and women, who balance their time with family and job responsibilities. In summary, it concludes that programs that combine individual and organizational change and are comprehensive in nature have the greatest chance of success.
The American College of Occupational and Environmental Medicine (ACOEM), in its 2009 paper, Healthy Workforce/Healthy Economy: The Role of Health, Productivity and Disability Management in Addressing the Nation’s Health Care Crisis, stresses the importance of a healthy and available workforce in the national and global economy further stating that the workforce is the engine that drives the economy and is thereby linked to the health care system overall. The paper further lays out the fundamental principles of occupational safety and health, including the need for investment in evidence-based prevention programs which lead to healthier workers through: Primary Prevention (health promotion activities, health education, safety engineering and hazard recognition); Secondary Prevention (screening, pro-active work disability prevention programs); Tertiary Prevention (disease management, rehabilitation, health care management).
Meanwhile, other demographic factors are impacting the viability of the workforce. According to a 2008 US Census Bureau report, over the next 20 years, the percent of Americans aged 65 and older will grow from the current 12 percent of the population to 21 percent. Many of them will be in the working population. This highlights the need for effective and comprehensive integrated programs in the US workplaces. According to Healthy Aging for a Sustainable Workforce, published following the Healthy Aging for Workers Conference, sponsored by the Association of Occupational and Environmental Clinics (AOEHC) and the Society of Occupational and Environmental Health (SOEH), the most prevalent events leading to job-related injuries or fatalities for older workers are falls, assaults, harmful exposures or transportation incidents. The nature of injuries is more severe than for younger workers; there are longer recovery periods for older workers; and, older workers die from workplace injuries at a higher rate than do younger workers. The report makes a case for the need for public policy development to meet the current and future challenges facing our society relative to older workers.
The working population of the country is becoming increasingly diverse; it is projected to become more than 50% minority in 2039 and 55 % minority in 2050 (US Census Bureau, 2008). There is evidence of health disparities in culturally diverse populations as compared to the health status of the population- discrepancies in life expectancy, and in rates of cancer, diabetes and cardiovascular disease. With regard to work, there is an overrepresentation of racial and ethnic minority workers in low income jobs and in occupations which potentially expose workers to chemical and physical hazards. A NORA priority in the NIOSH program portfolio is to improve research to define the nature and magnitude of risks experienced by special populations. The priority groups include agricultural workers, young workers, older workers, immigrant workers, workers with physical and developmental disabilities and health care workers. Another important group are the US Armed Forces Reserves and National Guard, an important component of the miliary serving overseas in the Global War, who are returning with combat exposures resulting in significant health and social problems. Little is known about health care and workplace accommodations on returning home and reintegration into civilian worklife. Further exploration around policies, programs and services to optimize their reentry into civilian work life is needed. Increasingly, researchers in the public health arena are also focusing on community- based collaborative interventions to engage workers who are employed in small business establishments, such as, hotel housekeepers, poultry processing workers and immigrant farm workers. Combined health protection and health promotion interventions have the opportunity for success in reducing health disparities in the future.
Research supported by this program is needed to demonstrate the positive impact of integrated health promotion and health protection programs on the safety and health of workers while also resulting in healthier work environments. The intent of this initiative is to support integration of these efforts into a more comprehensive worksite program that will result in an increased impact on workforce health. For the purpose of this announcement, health promotion activities without attention to the conditions and policies of the workplace is outside the scope of this program.
Objectives
The primary objective of this funding opportunity announcement is to establish and support Centers of Excellence to Promote a Healthier Workforce that will conduct and evaluate research, integrating both health promotion and health protection programs in the workplace, to produce healthy workers and healthier workplace environments. Building on prior and current NIOSH initiatives, and on worldwide attention and national demands to maintain the health of workers, a Center is expected to 1) Serve as a leader in research activities and expertise in the integration of health protection and health promotion; 2) Conduct trans-disciplinary research projects on the effects and outcomes of integrated health promotion and protection projects; 3) Conduct outreach and education activities in the region to create awareness of the value and benefits of healthy workers and workplaces and disseminate the results of research activities; 4) Establish partnerships with community agencies and organizations to encourage participation in Center projects and activities designed to promote healthy workers and healthy workplaces; and, 5) Conduct evaluation activities at the project level and at the overall Center level.
The intent of the Centers is to expand the mission of NIOSH in protecting and promoting the health of the diverse population of workers in the nation. In this effort, NIOSH not only retains their primary mission of protecting workers but provides funding for essential research that support projects and activities in this area that are currently being conducted nationally by employers and that will help define this non-traditional approach for the occupational health community.
This will be accomplished by conducting and evaluating trans-disciplinary research, education and translation projects, and providing outreach and education programs to the community. A Center for Excellence to Promote a Healthier Workforce is expected to carry out these initiatives with multi-disciplinary teams including professionals in occupational health and safety (medicine, nursing, industrial hygiene, safety, ergonomics), psychology, behavioral and social sciences, policy, labor education, health education, business and economics. Collaborations between academic institutions to conduct interventions are strongly encouraged.
Centers will institute collaborative partnerships with local and state agencies, community organizations, universities, health care institutions, business groups, and labor organizations to carry out research activities, conduct outreach programs, promote awareness and disseminate information. Partnerships are critical to translate research into practice and encouraged by the NIOSH Research-to-Practice Program (r2p). Interdisciplinary and trans-disciplinary collaboration among investigators and institutions to utilize and share existing disciplinary expertise is essential in advancing the science of the occupational health and safety field in combination with the health promotion of workers in the work environment.
Applications to this announcement must address the specific objectives of this announcement. Topics that have been identified as appropriate for this FOA include, but are not limited to, the following:
Social epidemiology research
Methods development research
Efficacy research
Effectiveness research
Dissemination and durability research
Proposed projects must embody specific attention to evaluating and ameliorating risks from workplace conditions and exposures.
Essential Components of a Center of Excellence
The Center of Excellence cooperative agreement is expected to support multidisciplinary research and activities that have a strong evaluation component, address the priorities in this Announcement, and include dissemination of research results and information on integrated programs to the community, workers and employers. A Center of Excellence is expected to have the following components that together address the objectives of a Center:
These essential components must work cooperatively to address the objectives of the Center. The percentage allocated for each component is provided as a general guideline to allow some flexibility but substantial deviations must be fully justified and approved. Center-wide Outreach activities may be included in the Administration core. If it is not, it could be designated a separate core activity in the Center or included in activities in the Education, Translation, Communication and Dissemination program.
Administrative, Planning and Outreach (APO) Core (About 25% of the annual budget)
The Administrative and Planning Core is necessary to carry out the objectives of the Center and plan for new directions. It includes Center Management, External Advisory Committee, Internal Steering Committee, the Pilot Project Program, Outreach activities and an Evaluation component.
The Center must have strong leaders who are committed to the program and 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 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:
Outreach activities
Essential functions of the outreach component of the administrative core include but are not limited to, coordinating and collaborating across disciplines including, occupational safety and health, economics, business, labor education, labor relations, health education, occupational health nursing and medicine, engineering, injury and chronic disease prevention, surveillance and research methods to identify key issues and needs. This also includes collaborative research opportunities, as well as education of community partners and assistance and consultation to agencies and employers as needed in establishing health protection/health promotion programs. Centers should also consider working with state policy makers to ensure that information regarding health promotion/prevention programs is available through participating insurance carriers, the broker community and employee benefit companies.
Pilot Projects.
Pilot projects are considered an important and integral part of support provided to the Center. Support of pilot projects in the intervention effectiveness research, education, and translation project areas within the Center is considered fundamental to sustaining the quality, breadth, and dynamics of this program. Investigators must include at least $50,000 of the annual administrative and planning costs for these projects. These projects are intended for the exploration and development of new and creative intervention effectiveness research, education and translation projects. Therefore, funds should be designated to provide support for short-term projects to explore the feasibility of new projects in any of the Center's program areas. Any projects that would be conducted beyond the U.S. and terroritories must be submitted to the NIOSH program official for prior approval. The request for approval must include documentation of IRB approval both from the grantee institution as well as from the appropriate IRB within the host country.
This program will enable investigators to collect sufficient data to pursue support through other funding mechanisms. Funds should be designated to provide support for short-term projects (12 months or less) to explore new areas in the Center s core programs. This is an opportunity for new investigators to collect sufficient data to pursue support through other funding mechanisms. Pilot projects can include but are not limited to:
Providing initial support for new investigators to develop innovative approaches of investigation that address the Center’s mission and objectives.
Encouraging investigators from other fields of study to apply their expertise to approaches, methods and barriers in implementing health protection/health promotion programs.
While the administrative framework for management of the Center’s Pilot project program is left to the Center Director’s discretion, certain minimal requirements must be met. Management must include provisions for:
Center and Program Evaluation
Centers are expected to conduct evaluation of both scientific projects and activities related to overall functioning and objectives of the Center. Evaluations assist in the translation of interventions into numerous workplaces that are important to NIOSH and its research-to-practice (r2P) initiative. Evaluations also provide information for management and improve program effectiveness. The CDC Framework for Program Evaluation in Public Health may be helpful and can be accessed at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4811a1.htm
Trans-Disciplinary Exploratory, Efficacy, Effectiveness and Evaluation Research Projects (About 55% of annual budget)
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, sustainability, 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 (About 20% of the annual budget)
Education projects are projects designed to promote communication and understanding of knowledge and skills to professional students, practicing professionals, employers and workers, policymakers, and community groups 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 of Support
This funding opportunity will use the HHS/CDC U19 cooperative agreement assistance award
mechanism. Under this funding mechanism, the
Recipient Organization and the Project Director/Principal Investigator (PD/PI)
retain the primary responsibilities and dominant roles for planning, directing,
and executing the proposed project. NIOSH staff will be substantially involved
as a partner as described under the Section VI. 2A.
Administrative and National Policy Requirements,
"Cooperative Agreement Terms and Conditions of Award".
This FOA uses Just-in-Time information concepts. It also uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
2.
Funds Available
NIOSH intends to
commit a total of approximately $5 million in FY2011 to fund 3-5 cooperative
agreements in response to this FOA for a period of up to 5 years. Future year amounts
will depend on annual appropriations.
Although the financial plans of NIOSH 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.
HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
The following organizations/institutions are
eligible to apply:
A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Attach this documentation behind the first page of your application form.
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 research as the PD/PI is invited to work with his/her institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC program support.
2. Cost
Sharing or Matching
This program does not require cost
sharing as defined in the current HHS Grants Policy Statement.
3. Other Special
Eligibility Criteria
Number of Applications. Applicants may not submit more than one
application.
Resubmissions. Resubmission applications are not permitted in response to this FOA.
Renewals. Renewal applications are permitted in response to this FOA.
Section IV. Application and Submission Information
1. Address to Request Application Information
The current 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 PGO TIMS: Telephone 770-488-2700, Email: [email protected]
Telecommunications for the hearing
impaired: TTY 770-488-2783.
2. Content and Form
of Application Submission
Prepare all applications using the
PHS 398 application forms and in accordance with the PHS 398 Application Guide
(http://grants.nih.gov/grants/funding/phs398/phs398.html).
Applications must have a D&B
Data Universal Numbering System (DUNS) number as the universal identifier when
applying for Federal grants or cooperative agreements. The D&B number can
be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the
face page of the PHS 398 form.
The title and number of this funding opportunity must
be typed in item (box) 2 only of the face page of the application form and the
YES box must be checked.
Following is the expected format for the Table of Contents in preparing your application. Review and modify the Table of Contents in the 398 Instructions (Form Page 3).
TABLE OF CONTENTS FOR CENTER OF EXCELLENCE TO PROMOTE A HEALTHIER WORKFORCE APPLICATIONS
Type density of the application must conform to the limits provided in the 398 application instructions on I-14
The CDC U19 activity code uses ONLY the detailed Research and Related Budget (do not use the PHS 398 Modular Budget).
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(s): November 15,
2010
Application Receipt
Dates(s): December 17, 2010
Peer Review
Date(s): March 2011
Council Review Date(s): May,
2011
Earliest
Anticipated Start Date: August 2011
Additional Information to Be
Available Date (URL Activation Date): Not applicable
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 NIOSH staff to estimate the potential
review workload and plan the review.
The letter of intent is to be sent by the date listed
in Section IV.3.A.
The letter of intent should be sent to:
Price Connor, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road
Mailstop E-74
Atlanta, GA 30329-4018
404-498-2511
Fax 404-498-2571
Email: [email protected]
3.B. Submitting an Application
Applications to this FOA will be received at the
Center for Scientific Review, National Institutes of Health. Applications must
be prepared using the forms found in the PHS 398 instructions for preparing a
research grant application. Submit a signed, typewritten original of the
application, including the checklist, three signed photocopies and submit the
appendix materials (if any) on three identical CDs in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At the time
of submission, two additional paper copies of the application and 5 CDs of the
appendix materials (if any) must be sent to:
Price Connor, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
1600 Clifton Road
Mailstop E-74
Atlanta, GA 30329-4018
404-498-2511
Fax 404-498-2571
Email: [email protected]
3.C. Application
Processing
Applications must be received on or before the
application receipt date described above (Section
IV.3.A.). If an application is received after that
date, the application may be delayed in the review process or not reviewed. Upon
receipt, applications will be evaluated for completeness by the CSR and for
responsiveness by the NIOSH. Incomplete and/or non-responsive applications will
not be reviewed.
Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.
HHS/CDC will not accept any application in response to this FOA 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
Executive Order 12372 does not
apply to this program.
5. Funding Restrictions
All HHS/CDC awards are subject to the terms and
conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Restrictions, which applicants must take into account while writing their budgets, are as follows:
Funds relating to the conduct of research will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.
Reimbursement of pre-award costs is not allowed.
Funds for renovation of existing facilities or to purchase substantial amounts of equipment will generally not be allowed. Any such requests must be well justified as critical for the success of the overall Program.
6. Other Submission Requirements
Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".
PHS 398 Research Plan Sections
All application instructions outlined in the PHS398 Application Instructions are to be followed, with the following additional requirements:
Specific Aims is limited to 1 page.
Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to 12 pages per project.
Budget
This FOA uses non-modular budget formats described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html).
Appendix Materials
All paper PHS 398 applications submitted must provide appendix material on CDs only. Include five identical CDs in the same package with the two application copies to the NIOSH Scientific Review Officer listed in Section IV.3.B.
Do not use the Appendix to circumvent the page limitations. An application that does not observe the required page limitations may not be considered in the review process.
Resource Sharing Plan(s)
All applicants must include a plan for sharing research data in their application. The HHS/CDC data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements Release and Sharing of Data . All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.
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 should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation they will provide, 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 the awardee will place any conditions 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). References to data sharing may also be appropriate in other sections of the application.
The reasonableness of the data sharing plan or the rationale for not sharing research data will 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
HHS policy
requires that grant award recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (see the HHS Grants Policy Statement 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 the HHS/CDC 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.
2. Review and Selection
Process
Review Process
Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by CDC/NIOSH and in accordance with HHS peer review procedures (http://grants1.nih.gov/grants/peer/), using the review criteria stated below.
As part of the scientific peer review, all applications will:
Receive a second level of review by the NIOSH Secondary Review Committee.
The mission of CDC is to promote health and quality of life by preventing and controlling disease, injury, and disability. The goal of the NIOSH research and training programs is to identify the risks and conditions that are associated with occupational diseases and injuries, to explore methods for reducing risks and for preventing or minimizing exposure to hazardous conditions in the workplace, and to translate significant scientific findings into prevention practices and products that will effectively reduce work-related illnesses and injuries. The scientific review group will address and consider each of the review criteria in assigning the application's overall score, weighting them as appropriate for each application.
Overall Impact
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, Review Criteria for Renewal Applications, and additional review criteria (as applicable for the projects or programs proposed).
Scored Review Criteria
Reviewers will consider each of the five scored review criteria below in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance: Is the Center likely to have an impact in meeting the national need for healthy worksites and healthy workers through research, education and partnership activities? For existing Centers, have they contributed to the NIOSH mission and the mission of the occupational safety and health field as demonstrated by their accomplishments? How will scientific knowledge be advanced by establishing comprehensive worksite programs benefitting both workplaces and employees? Are collaborative relationships which have been established at worksites likely to contribute to the knowledge, benefits and sustainability of health protection/health promotion programs for a healthier workforce?
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 qualifications of the Center Director and Program Directors as evidenced by education, experience and accomplishments adequate to accomplish the goals and mission of the Center? Does the investigative team bring complimentary and integrated expertise to the projects?
Innovation: Does the Center propose new and novel projects or do they build on current projects? Are new areas of investigation proposed that are challenging and have the potential for success? To what degree does the proposed program design address the distinct characteristics, specific populations and health needs in occupational safety and health?
Approach: Is the entire program cohesive in integrating all projects, facilitating interdisciplinary and trans-disciplinary interaction and likely to produce results that are translatable to the practice field of occupational safety and health? For existing Centers, has the organization and structure of the Center contributed to producing measurable results and accomplishments? Is there an evaluation in place for the entire Center? Is there appropriate collaboration with public and private community organizations, professional groups, industry and labor that will enhance the work of the Center and provide continuity? Is there a plan for dissemination of project results?
Environment: Is there evidence of institutional commitment as evidenced by sufficient resources, technical support and administrative arrangements and facilities that facilitate collaboration among researchers? Is there a plan for reaching out to other university environments, state agencies and professional groups?
Review Criteria for Renewal Applications
Past Performance: Center record of demonstrated impacts in meeting the national need for healthy worksites and healthy workers through research, education and partnership activities. Center accomplishments in: advancing scientific knowledge and establishing comprehensive worksite programs to benefit workplaces and employees. Have sustainable, comprehensive, collaborative health protection/health promotion programs been developed for a healthier workforce? Has the Center established itself as a recognizable entity in occupational safety and health? Has the organization and structure of the Center contributed to producing measurable results and accomplishments? Is there an evaluation in place for the entire Center? Publications by Center investigators, conferences, new funded research grants in occupational safety and health, new collaborations with other organizations, etc.
In addition to the above review criteria, the following criteria will also be applied to applications in the determination of scientific merit and the impact/priority score.
Review Criteria for the Administrative, Planning and Outreach Core
The following five scored review criteria will be used to assess the APO Core:
Adequacy of Administrative Core: Are there adequate administrative and management plans to support all operational facets of the Center? Is the Center Director adequately supported and sufficient management depth to provide long-term continuity of Center leadership? Does the administrative structure facilitate communication among Center leaders and project scientists? Are plans for routine management, allocation of funds and partnerships designed to effectively achieve Center objectives?
Adequacy of Internal/External Advisory Committees: Are there appropriate plans for organizing and convening internal and external committees to advise the Center Director? Is the External Board comprised of leaders and stakeholders from the community with expertise appropriate for the projects and mission of the Center? Does the role of the Board include oversight and making recommendations to the Center which are considered and adopted?
Adequacy of Outreach Plan: Does the program adequately describe activities that will impact other institutions or agencies located within the ERC region? Does the program facilitate the translation of occupational safety and health findings into the work environment? Are appropriate occupational safety and health constituents engaged in the program? Will the proposed activities have an impact on the practitioner or ability to affect occupational safety and health?
Adequacy of Pilot Projects Program: Are the goals for the program well described? Is the plan to conduct the Pilot Projects Program adequate? This includes procedures for reviewing and funding projects, the scientific review mechanism, and program quality assurance. Does the applicant encourage participation by other investigators within the institution or at regional institutions? Is the plan for announcing the Pilot Projects Program adequate? Does the investigator provide a plan for retaining copies of all proposals, with documentation of reviews, relative ranking, and final action? Is there a mechanism for tracking the results of each Pilot Project study?
Adequacy of Center Evaluation: Does the application describe evaluation of scientific projects, the overall Center, and Center objectives to assess the effectiveness of the Center? Are there plans to obtain feedback from advisors, partners, stakeholders, workers or employers to assess the quality and effectiveness of health promotion/health protection programs in the workplace to produce healthy workers and healthier workplace environments?
Review Criteria for Trans-disciplinary, Exploratory, Efficacy and Effectiveness Projects
The following five scored review criteria will be used to assess Trans-disciplinary, Exploratory, Efficacy and Effectiveness Projects:
Significance: Do the projects incorporate the concepts of health/protection/health promotion as specified in the Announcement? Are the audiences and target populations appropriate for the projects? Do the projects support and benefit current management efforts to establish and maintain sustainable programs for workers that are effective and promote the health of the workers and the workplace? Can the projects be translatable to the occupational health community?
Investigators: Are the Program Directors of the projects qualified by education and experience to conduct the research? Are sufficient staff and resources available to the researchers?
Innovation: Are the projects novel and innovative and relative to integrating the new concept of health protection/health promotion in order to develop a comprehensive program for employers and workers?
Approach: For existing Centers, do the projects build on existing projects or are new projects proposed? Is there evidence that the industries targeted for study are willing to participate and committed to the projects? Are the conceptual frameworks, methods, time lines and analyses developed or are they proposed? Are the projects feasible and can they be accomplished in the time frame proposed for the studies? Are barriers and limitations specified by the investigators? For new Centers, do projects build on past/current work or are they newly developed projects?
Environment: Are environments/sites targeted for research appropriate, and known to be committed to the studies? Does the environment in which the work will be done contribute to the success of the projects? Is there evidence of institutional support at these sites?
In addition to the above scored review criteria, the following criterion will also be applied to applications in the determination of scientific merit and the impact/priority score for Trans-disciplinary, Exploratory, Efficacy and Effectiveness Projects:
Project Focus: Does the project focus on improved understanding of health protection and health promotion issues? Does the project involve worksite-based programs? Does the project include a priority topic (e.g., social epidemiology, methods development, efficacy, effectiveness, dissemination and durability research)? Is there a well-defined evaluation plan, including process and outcome measures, to determine the efficiency and effectiveness of the techniques or programs? For intervention efficacy and effectiveness projects, is the focus on protecting and maintaining the health status of the workforce and improving health status?
Review Criteria for Education, Translation, Communication and Dissemination Projects
The following five scored review criteria will be used to assess Education, Translation, Communication and Dissemination Projects:
Significance: Is the program likely to successfully impact the region/community as evidenced by previous successful efforts and appropriate target populations? Does the program meet a need in the community and in the occupational health and safety field? Will the program contribute to sustained collaborative partnerships and advance scientific knowledge in the field?
Investigators: Are the qualifications of the leadership of the program, as evidenced by education, expertise and previous work, adequate to carry out the work and assure success?
Innovation: Do the projects utilize new and appropriate technologies, tools and concepts to assure success? Are the targeted audiences appropriate and are the tools/instruments in the appropriate language for successful usage?
Approach: Is there a plan in place and is it well-developed in design, objectives and content for the appropriate audiences? Are there adequate plans to assess the success or impact of the intervention on the targeted establishment in conducting health protection/health promotion programs for workers? Does the plan have appropriate collaborators committed to assisting the Centers in efforts to translate results to communities?
Environment: Does the scientific environment have the necessary resources and technical support available to conduct the work and demonstrate the commitment of the Center?
In addition to the above scored review criteria, the following criterion will also be applied to applications in the determination of scientific merit and the impact/priority score for Education, Translation, Communication and Dissemination Projects:
Adequacy of Communication Plan: Does the project include a cohesive plan for timely dissemination and translation of evidence-based techniques, tools or programs that integrate health promotion and health protection? Are appropriate communication interventions used to promote the adoption of evidence-based health protection practices? Does the project include strategic partnerships and collaborations to diffuse evidenced-based practices for preventing work-related illness, injury, and death into the workplace? Is there a process for ensuring that the communication materials developed are culturally, linguistically and educationally appropriate?
2.A. Additional Review Criteria
As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit, but will not give separate scores for these items.
Protections for Human Subjects. For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.
Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Inclusion of Women, Minorities, and Children. When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. Please see http://www.cdc.gov/OD/foia/policies/inclusio.htm for more information.
Vertebrate Animals. The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.
Biohazards. Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmission Applications. Not applicable.
Renewal Applications. When reviewing a Renewal application, the committee will consider the progress made in the last funding period.
Revision Applications. Not applicable.
2.B Additional Review Considerations
As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations. Not applicable.
Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource and Data Sharing Plans. HHS/CDC policy requires that recipients of grant awards make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication. Please see: http://www.cdc.gov/od/foia/policies/sharing.htm. Investigators responding to this funding opportunity should include a plan on sharing research resources and data.
Reviewers will comment on whether the Resource and Data Sharing Plans, or the rationale for not sharing resources or data, are reasonable.
Program staff will be responsible for the administrative review of the plan for sharing research resources and data. The adequacy of the resources sharing plan 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 (HHS/PHS 2590; http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
Budget and Period Support. Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Selection Process
The following will be considered in making funding decisions:
3.
Anticipated Announcement and Award Dates
Not
Applicable.
Section
VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed,
the PD/PI will be able to access his or her Summary Statement (written
critique) via the eRA
Commons.
If the application is under consideration for funding,
HHS/CDC will request "just-in-time" information from the applicant.
For details, applicants may refer to the HHS Grants Policy
Statement .
A formal notification in the form
of a Notice of Award (NoA) will be provided to the applicant organization.
The NoA signed by the grants management officer is the authorizing document.
Once all administrative and programmatic issues have been resolved, the NoA
will be generated via email notification from the awarding component to the
grantee business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the
NoA are at the recipient's risk. These costs may be reimbursed only to the
extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
2.
Administrative and National Policy Requirements
The Code of Federal Regulations 45 CFR Part 74 and
Part 92 have details about requirements. For more information on the Code of
Federal Regulations, see the National Archives and Records Administration at
the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. Additional requirements are available Section VIII. Other
Information of this document or on the HHS/CDC website at the following
Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.
The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courteous copy to the PD/PI at the time of award.
2.A. Cooperative Agreement Terms and Conditions of
Award
The following terms of award are
in addition to, and not in lieu of, otherwise applicable Office of Management
and Budget (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/CDC grant
administration policies.
The administrative and
funding instrument used for this program will be the cooperative agreement, an "assistance" instrument (rather than an
"acquisition" instrument), in which substantial HHS/CDC programmatic
involvement with the awardees is anticipated during the performance of the
activities. Under the cooperative agreement, the HHS/CDC 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 HHS/CDC may share
specific tasks and activities, as defined below.
2.
A.1. Principal Investigator Rights and Responsibilities
The recipient will have the primary responsibility of all management, administrative and scientific aspects of the Program. The grantee is strongly encouraged to review the HHS grant policy statement, for aid with post award administration, at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.
Recipient Organizations will retain custody of and have primary rights to the information, data and software developed under this award, subject to U.S. Government rights of access consistent with current HHS/CDC policies.
The recipient will coordinate project activities technically, scientifically and administratively at the awarded institution and at other sites that may be supported by sub-contracts to this award. The applicant will have primary authority and responsibility to define objectives and approaches; collect and analyze data; and to publish results, interpretations, and conclusions of studies conducted under the terms and conditions of the program award. The applicant must obtain the appropriate Institutional Review Board approvals for research involving human subjects for all participating sites
Recipients will have responsibility for the
activities listed in Section I
2. A.2. HHS/CDC Responsibilities
NIOSH Program Official
One representative from NIOSH Office of Extramural Programs will be designated to serve as the Program Official for this cooperative agreement. The Program Official will have routine programmatic involvement during the conduct of this activity through technical assistance, review of aims for pilot and research projects, approval for added subprojects that have undergone NIOSH meritorious review, approval of progress report, approval of pilot study guidance/plan and human subjects protection, approval of annual summary report, advice and coordination consistent with normal program stewardship for grants, as described below. This person will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the Notice of Award (NoA). Responsibilities of the Program Official include the following:
NIOSH Project Scientist(s)
NIOSH anticipates having substantial scientific involvement during conduct of this activity in the form of scientific and technical assistance, collaboration, guidance and coordination. Responsibilities of the NIOSH Project Scientist(s) include the following:
Upon request of the award recipient, provide expert consultation in the area of occupational health protection/health promotion activities, and other occupational health related functions and activities as needed.
Serve as a subject matter expert for NIOSH.
Upon request of the award recipient, provide advice on formats for data reporting and coding, computer software and electronic storage of data.
Scientific collaboration, upon request.
Upon invitation by Center, attend meetings and workshops.
With the Program Official, facilitate coordination and collaboration among grantees on meeting agendas, and prevention activities and opportunities as needed.
Attend and actively participate in the planning and implementation of grantee meetings as needed.
Facilitate collaborative efforts to compile and disseminate program results through presentations and publications.
Publish with the awardee if mutually agreeable and warranted by the nature and extent of his/her intellectual contribution to the program or project.
NIOSH Project Scientists will be named in the Notice of Award and will work closely with the recipient and the NIOSH Program Official.
2.A.3. Collaborative Responsibilities
If more than one Center is funded, a Coordinating Committee (CC) may be formed to 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 may participate in CC meetings as appropriate, but will not have voting privileges. The CC may designate working groups comprised of staff from each Center for specific purposes. These multi-site committees could provide a means to share data, enhance translation, or help provide focus on specific issues of national importance.
2.A.4.
Dispute Resolution
Any disagreements that may arise in
scientific or programmatic matters (within the scope of the award) between
award recipients and the NIOSH may be brought to Dispute Resolution. A Dispute
Resolution Panel composed of three members will be convened. It will have three
members: a designee of the Steering Committee chosen without NIOSH staff
voting, one NIOSH designee, and a third designee with expertise in the relevant
area who is chosen by the other two; in the case of individual disagreement,
the first member may be chosen by the individual awardee. This special dispute
resolution procedure does not alter the awardee's right to appeal an adverse
action that is otherwise appealable in accordance with PHS regulations 42 CFR
Part 50, Subpart D and HHS regulations 45 CFR Part 16.
3.
Reporting
Recipient Organization must provide
HHS/CDC with an original, plus two hard copies of the following reports:
Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the Agency Contacts section of this FOA.
Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.
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:
Bernadine
Kuchinski, Ph.D.
Office
of Extramural Programs
Robert
A. Taft Laboratories,
4676 Columbia Pkwy. MS C-7
Cincinnati,
OH 45226
Telephone:
(513) 533-8511
FAX:
513-533-8564
Email:
[email protected]
2. Peer Review Contacts:
Price Connor, Ph.D.
CDC/NIOSH/OEP
Clifton Road NE, MS E-74
Atlanta, GA 30329-4018
404/498-2511
404/498-2571 (fax)
Overnight mail address:
2400 Century Parkway NE (4th Floor)
Atlanta GA 30345-3114
3.
Financial or Grants Management Contacts:
Maryann
P. Monroe
Grants
Management Specialist
Acquisition
& Assistance Field Branch
P.O.
Box 18070, 626 Cochrans Mill Road
Pittsburgh,
PA 15236-0070
Telephone:
(412) 386-5075
E-Mail: [email protected]
Fax:
(412) 386-6429
4.
General Questions Contacts:
Technical Information Management Section
CDC Procurement and Grants Office
U.S. Department of Health and Human
Services
2920 Brandywine Road
Atlanta, GA 30341
Telephone: 770-488-2700
Email: [email protected]
Section VIII. Other Information
Required
Federal Citations
Human
Subjects Protection
Federal
regulations (45 CFR Part 46) require that applications and proposals involving
human subjects must be evaluated with reference to the risks to the subjects,
the adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). Additional HHS/CDC Requirements under AR-1 Human
Subjects Requirements can be found on the Internet at the following
address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Use of Animals in
Research
Recipients of PHS support for activities involving live, vertebrate animals
must comply with the PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act
of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable. Additional HHS/CDC Requirements
under AR-3 Animal Subjects Requirements can be found at http://www.cdc.gov/od/pgo/funding/ARs.htm.
Requirements for
Inclusion of Women and Racial and Ethnic Minorities in Research
It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.
Inclusion of Persons Under the Age of 21 in Research
The policy of CDC is that persons under the age of 21 must be included in all
human subjects research that is conducted or supported by CDC, unless there are
scientific and ethical reasons not to include them. This policy applies to all
CDC-conducted or CDC-supported research involving human subjects, including
research that is otherwise exempt in accordance with Sections 101(b) and 401(b)
of 45 C.F.R. Part 46, HHS Policy for the Protection of
Human Subjects. Therefore, proposals
for research involving human subjects must include a description of plans for
including persons under the age of 21. If persons under the age of 21 will be
excluded from the research, the application or proposal must present an
acceptable justification for the exclusion.
In the application, the investigator should create a section titled
"Participation of persons under the age of 21." This section should
provide either a description of the plans to include persons under the age of
21 and a rationale for selecting or excluding a specific age range, or an
explanation of the reason(s) for excluding persons under the age of 21 as
participants in the research. When persons under the age of 21 are included,
the plan must also include a description of the expertise of the investigative
team for dealing with individuals at the ages included, the appropriateness of
the available facilities to accommodate the included age groups, and the
inclusion of a sufficient number of persons under the age of 21 to contribute
to a meaningful analysis relative to the purpose of the study. Scientific
review groups at CDC will assess each application as being acceptable or
unacceptable in regard to the age-appropriate inclusion or exclusion of persons
under the age of 21 in the research project, in addition to evaluating the
plans for conducting the research in accordance with these provisions.
The inclusion of children (as defined by the applicable law of the jurisdiction
in which the research will be conducted) as subjects in research must be in
compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations. The
policy of inclusion of persons under the age of 21 in CDC-conducted or
CDC-supported research activities in foreign countries (including collaborative
activities) is the same as that for research conducted in the United States.
HIV/AIDS Confidentiality Provisions
Recipients must have confidentiality and security provisions to protect data collected through HIV/AIDS surveillance, including copies of local data release policies; employee training in confidentiality provisions; State laws, rules, or regulations pertaining to the protection or release of surveillance information; and physical security of hard copies and electronic files containing confidential surveillance information.
Describe laws, rules, regulations, or health department policies that require or permit the release of patient-identifying information collected under the HIV/AIDS surveillance system to entities outside the public health department; describe also the measures the health department has taken to ensure that persons reported to the surveillance system are protected from further or unlawful disclosure.
Some
projects may require Institutional Review Board (IRB) approval or a certificate
of confidentiality.
HIV Program Review Panel
Requirements
Compliance with Content of AIDS-Related Written Materials, Pictorials,
Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions
(June 1992) is required. To meet the requirements for a program review panel,
you are encouraged to use an existing program review panel, such as the one
created by the State health department's HIV/AIDS prevention program. If you
form your own program review panel, at least one member must be an employee (or
a designated representative) of a State or local health department. List the
names of the review panel members on the Assurance of Compliance form, CDC
0.1113. Submit the program review panel's report that all materials have been
approved. If the proposed project involves hosting a conference, submit the
program review panel's report stating that all materials, including the proposed
conference agenda, have been approved. Submit a copy of the proposed agenda
with the application.
Before funds are used to develop educational materials, determine whether
suitable materials already exist in the CDC National Prevention Information Network
(NPIN). The website can be found at: http://www.cdcnpin.org/.
Patient Care
Ensure that all STD or HIV infected patients enrolled in the proposed project
will be linked to an appropriate local care system that can address their
specific needs, such as medical care, counseling, social services, and therapy.
Public Health System
Reporting Requirements
This program is subject to the Public Health System Reporting Requirements.
Under these requirements, all community-based non-governmental organizations
submitting health services applications must prepare and submit the items
identified below to the head of the appropriate State and/or local health
agency(s) in the program area(s) that may be impacted by the proposed project
no later than the application deadline date of the Federal application. The
appropriate State and/or local health agency is determined by the applicant.
The following information must be provided:
A. A copy of the face page of the application (PHS398).
B. A summary of the project that should be titled "Public Health System
Impact Statement" (PHSIS), not exceed one page, and include the following:
If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.
Paperwork Reduction Act Requirements
Under the Paperwork Reduction Act, projects that involve the collection of
information from 10 or more individuals and funded by a grant or a cooperative
agreement will be subject to review and approval by the Office of Management
and Budget (OMB).
Smoke-Free Workplace Requirements
HHS/CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.
Healthy People 2010
The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2010," a PHS-led
national activity for setting priority areas. This FOA is related to one or
more of the priority areas. Potential applicants may obtain a copy of
"Healthy People 2010" at www.healthypeople.gov
Lobbying Restrictions
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier 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 HHS/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, HHS/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 HHS/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 healthful environments.
Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent HHS/CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.
Prohibition on Use of HHS/CDC Funds for Certain Gun Control Activities
The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."
Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.
In addition to the restrictions in the Anti-Lobbying Act, HHS/CDC interprets the language in the HHS/CDC's Appropriations Act to mean that HHS/CDC 's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.
Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.
Capability Assessment
It may be necessary to conduct an on-site evaluation of some applicant
organization's financial management capabilities prior to or immediately
following the award of the grant or cooperative agreement. Independent audit
statements from a Certified Public Accountant (CPA) for the preceding two
fiscal years may also be required.
Proof of Non-profit
Status
Proof of nonprofit status must be submitted by private nonprofit organizations
with the application. Any of the following is acceptable evidence of nonprofit
status: (a) a reference to the applicant organization's listing in the Internal
Revenue Service's (IRS) most recent list of tax-exempt organizations described
in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax
exemption certificate; (c) a statement from a State taxing body, State Attorney
General, or other appropriate State Official certifying that the applicant
organization has a nonprofit status and that none of the net earnings accrue to
any private shareholders or individuals; (d) a certified copy of the
organization's certificate of incorporation or similar document that clearly
establishes nonprofit status; (e) any of the above proof for a State or
national parent organization and a statement signed by the parent organization
that the applicant organization is a local nonprofit affiliate.
Security Clearance
Requirement
All individuals who will be performing work under a grant or cooperative
agreement in a HHS/CDC-owned or leased facility (on-site facility) must receive
a favorable security clearance, and meet all security requirements. This means
that all awardees employees, fellows, visiting researchers, interns, etc., no
matter the duration of their stay at HHS/CDC must undergo a security clearance
process.
Small, Minority, And Women-owned
Business
It is a national policy to place a fair share of purchases with small, minority
and women-owned business firms. The Department of Health and Human Services is
strongly committed to the objective of this policy and encourages all
recipients of its grants and cooperative agreements to take affirmative steps to
ensure such fairness. In particular, recipients should:
Research Integrity
The signature of the institution official on the face page of the application
submitted under this Funding Opportunity Announcement is certifying compliance
with the Department of Health and Human Services (DHHS) regulations in Title 42
Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH
MISCONDUCT.
The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).
For
example:
Section 93.301 Institutional assurances. (a) General policy. An institution
with PHS supported biomedical or behavioral research, research training or
activities related to that research or research training must provide PHS with
an assurance of compliance with this part, satisfactory to the Secretary. PHS
funding components may authorize [[Page 28389]] funds for biomedical and
behavioral research, research training, or activities related to that research
or research training only to institutions that have approved assurances and
required renewals on file with ORI. (b) Institutional Assurance. The
responsible institutional official must assure on behalf of the institution
that the institution-- (1) Has written policies and procedures in compliance
with this part for inquiring into and investigating allegations of research
misconduct; and (2) Complies with its own policies and procedures and the
requirements of this part.
Compliance with Executive Order 13279
Faith-based organization are eligible to receive federal financial assistance,
and their applications are evaluated in the same manner and using the same
criteria as those for non-faith-based organizations in accordance with
Executive Order 13279, Equal Protection of the Laws for Faith-Based and
Community Organizations. All applicants should, however, be aware of
restrictions on the use of direct financial assistance from the Department of
Health and Human Services (DHHS) for inherently religious activities. Under the
provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive
direct financial assistance from DHHS under any DHHS program may not engage in
inherently religious activities, such as worship, religious instruction, or
proselytization as a part of the programs or services funded with direct
financial assistance from DHHS. If an organization engages in such activities,
it must offer them separately, in time or location, from the programs or
services funded with direct DHHS assistance, and participation must be
voluntary for the beneficiaries of the programs or services funded with such
assistance. A religious organization that participates in the DHHS funded
programs or services will retain its independence from Federal, State, and local
governments, and may continue to carry out its mission, including the
definition, practice, and expression of its religious beliefs, provided that it
does not use direct financial assistance from DHHS to support inherently
religious activities such as those activities described above. A faith-based
organization may, however, use space in its facilities to provide programs or
services funded with financial assistance from DHHS without removing religious
art, icons, scriptures, or other religious symbols. In addition, a religious
organization that receives financial assistance from DHHS retains its authority
over its internal governance, and it may retain religious terms in its
organization=s name, select its board members on a religious basis, and include
religious references in its organization=s mission statements and other
governing documents in accordance with all program requirements, statutes, and
other applicable requirements governing the conduct of DHHS funded activities.
For further guidance on the use of DHHS direct financial assistance see Title
45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based
Organizations, and visit the internet site:
http://www.whitehouse.gov/government/fbci/
Health Insurance Portability and
Accountability Act Requirements
Recipients of this grant award should note that pursuant to the Standards for
Privacy of Individually Identifiable Health Information promulgated under the
Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160
and 164) covered entities may disclose protected health information to public
health authorities authorized by law to collect or receive such information for
the purpose of preventing or controlling disease, injury, or disability,
including, but not limited to, the reporting of disease, injury, vital events
such as birth or death, and the conduct of public health surveillance, public
health investigations, and public health interventions. The definition of a
public health authority includes a person or entity acting under a grant of
authority from or contract with such public agency. HHS/CDC considers this
project a public health activity consistent with the Standards for Privacy of
Individually Identifiable Health Information and HHS/CDC will provide
successful recipients a specific grant of public health authority for the
purposes of this project.
Release and Sharing of Data
The Data Release Plan is the Grantee's assurance that the dissemination of any
and all data collected under the HHS/CDC data sharing agreement will be
released as follows:
April
16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health
Insurance Portability and Accountability Act (HIPPA), (where applicable), The
Office of Management and Budget Circular A110, (2000) revised 2003, http://www.whitehouse.gov/omb/search/?keywords=releasing%20and%20sharing%20of%20dataand Freedom of Information Act (FOIA) http://www.cdc.gov/od/foia.
Applications must include a copy of the applicant's Data Release Plan.
Applicants should provide HHS/CDC with appropriate documentation on the
reliability of the data. Applications submitted without the required Plan may
be ineligible for award. Reviewers may consider the data sharing plan but will
not factor the plan into the determination of the scientific merit or the
impact/priority score. Award will be made when reviewing officials have
approved an acceptable Plan. The successful applicant and the Program Manager
will determine the documentation format. HHS/CDC recommends data is released in
the form closest to micro data and one that will preserve confidentiality.
National Historic
Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915)
The grantee’s signature on the grant application attests to their: (1)
knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665,
80 Stat. 915); and (2) intent to ensure all grant related activities are in
compliance with referenced public law, as stated:
a. Section 106 of the National Historic Preservation Act (NHPA) states:
The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking, shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register. The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.
b. Additionally, the NHPA also contains the following excerpt that forbids anticipatory demolition:
Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.
Conference Disclaimer and Use of
Logos
Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant
or a contract the recipient must include the following statement on conference
materials, including promotional materials, agenda, and internet sites:
Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) . The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.
Logos: Neither the HHS nor the CDC ( CDC includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003). Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer. It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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