Source: http://grants1.nih.gov/grants/guide/rfa-files/RFA-OH-11-001.html
Timestamp: 2015-05-07 08:06:36
Document Index: 567608483

Matched Legal Cases: ['art 52', 'art 74', 'art 92', 'art 46', 'art 46', 'art 87', 'arts 160']

RFA-OH-11-001: Centers of Excellence to Promote a Healthier Workforce (U19)
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
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
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
is a reissue of RFA-OH-05-006.
January 20, 2012 - See Notice NOT-OH-12-801. This Notice is to inform grantees with active grants awarded under this RFA that they may submit revision applications for projects that were not funded as part of their new or renewal Center award in FY-11.
November 9, 2010 - See Notice NOT-OH-11-001 Notice Regarding Extension of Receipt, Letter of Intent and Expiration Dates.
(RFA) Number: RFA-OH-11-001
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
Council Review Date(s): May,
2011 Earliest Anticipated Start Date: August 2011
Expiration Date: (Extended to January 29, 2011 per NOT-OH-11-001), Original Date:December 18, 2010
Purpose. NIOSH
seeks to fund research that has the greatest potential to impact public health
and, thereby, to reduce the burden on the health of the workforce population. This program invites
applications from single institutions or consortia of institutions to establish
a Center of Excellence to Promote a Healthier Workforce that will conduct trans-disciplinary
research, education and translation programs to facilitate the integration of
health protection and health promotion programs in the workplace.
the U19 cooperative agreement award mechanism. Funds Available and Anticipated Number of Awards. For this funding opportunity, $5
million is available to fund approximately 3-5 awards.
applicant may request a budget for total costs of up to $1.3 million per year.
funding opportunity may not exceed five years for existing Centers and three
years for new Centers. Application Research
Strategy Length: The Research Strategy section for each proposed project may not
Eligible Institutions/Organizations. Institutions/organizations listed in Section III,1.A. are
eligible to apply. Eligible Project Directors/Principal Investigators (PDs/PIs). Individuals with the skills, knowledge, and
always encouraged to apply for CDC/NIOSH support. Number of PDs/PIs. Only one PD/PI may be designated on the
Resubmissions. Resubmission applications are not permitted in response to this FOA.. Renewals. Renewal
Special Date(s). This FOA uses non-standard due dates. Application Materials. See Section IV.1 for application materials. HHS/CDC
the following number: TTY 770-488-2783. Table
Intent B. Sending an Application C. Application Processing
A. Cooperative Agreement Terms and Conditions of Award 1. Principal
Investigator Rights and Responsibilities 2. NIOSH
Federal Citations Part II
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
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
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
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
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
Social epidemiology research Identify key work-related factors
associated with hazardous occupational exposures and risk-related
behaviors. Identify underlying causes of
disparities in the health of people who work.
Identify the effects of worksite
factors on workers with health disparities, such as underserved
populations and aging workers.
Epidemiologic studies to better
characterize work reintegration challenges within targeted civilian
occupational groups (e.g., law enforcement, fire service, aviation) Business, academia, and labor
partnerships to investigate policy and program effectiveness for
reintegrating military veterans into civilian work
Business and community partnerships to
facilitate access to health and vocational rehabilitation services, with
work sustainment goals
Methods development research
Development of appropriate measurement
tools to enable research on integrated programs. Development of new methods for
establishing integrated programs of worker protection and health promotion.
Economic methods and modeling research
to develop improved approaches to predicting, assessing, and documenting
the economic value of the health-related benefits of successful programs. Investigation of the use of results of
biological and physiological markers research in the developed of
integrated interventions to improve worker health and safety.
Investigating the costs/benefits
associated with comprehensive, coordinated work-based health
protection/health promotion interventions.
Efficacy research Examine the effects of integrated
interventions on both occupational health and safety outcomes and health
behavior changes in controlled/pilot settings. Effectiveness research
Evaluate the generalizability (to
other populations and other kinds of worksites) of successful pilot-tested
Determination and documentation of
effective practices and policies leading to successful integration in
diverse settings. Related economic modeling research. Evaluation research to determine the
aspects of policies, programs and interventions that are effective and
those that are not in addressing the health and safety of aging workers.
Investigation of the translation of
successful pilot tested interventions to other populations and worksites.
Dissemination and durability
Sustaining successful programs (beyond
NIOSH funding).
Communicating critical information to
key recipients effectively (focused dissemination).
Conducting interventions that lead to
the development of best practices guides, toolkits or other materials
which address both health protection and health promotion.
Proposed projects must embody
specific attention to evaluating and ameliorating risks from workplace
conditions and exposures.
of a 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: Administrative, Planning and Outreach
Core (about 25%of the total budget);
Trans-Disciplinary Exploratory,
Efficacy, Effectiveness and Evaluation Research Projects (about 55% of the
total budget); and
Education, Translation, Communication
and Dissemination Projects (about 20% of the total budget). 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.
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: Appropriate and
adequate organization and facilities for activities such as seminars,
workshops, reference collection, computer support, etc. The principal investigator
should provide a minimum of 10% time commitment (direct and in-kind) and
each member of the internal advisory committee should provide a minimum of
5% time commitment for the Center of Excellence's administration and
coordination. An Internal Steering/Advisory Committee
comprised of program directors from each core that will assist the principal
investigator in making scientific and administrative decisions in the operation
of the Center programs.
Advisory Committee that is comprised of representatives of labor,
business, public/private services and other relevant groups involved in
activities of the Center. Members should be recognized leaders in the
field of occupational safety and health and/or leaders in their respective
disciplines, e.g., economics, business, labor, etc.
A data/statistical support activity may
be included in the administrative core if needed for the Center. Such an
activity may be useful in performing consultative services for
employer-employee partnerships.
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
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
initial support for new investigators to develop innovative approaches of
investigation that address the Center’s mission and objectives.
investigators from other fields of study to apply their expertise to
approaches, methods and barriers in implementing health protection/health
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:
Appropriate announcement of funding
available for pilot projects and solicitation of proposals Merit review of proposals. Copies of
all proposals, with documentation of their reviews, relative ranking and final
action must be retained by the Center and must be available to the NIOSH /OEP Program
Official and to reviewers participating in site visits conducted by NIOSH.
Recording and reporting results of each
funded project (abstract, publications, subsequent grant applications, etc.)
should be available to the NIOSH/OEP Scientific Program official and to
reviewers participating in site visits conducted by NIOSH. Input from the
Internal and External Advisory Committees into the management of the program is
Appropriate IRB review and approval for
all pilot projects involving human subjects to ensure protection of the rights
and welfare of human subjects (see 45 Code of Federal Regulations 46). This
must be obtained prior to project funding and applies also to projects
conducted by other institutions. The IRB must be registered with the DHHS Ofice
of Human Research Protections and must have a current Federalwide Assurance
Number. Documentation of IRB approval of protocols, and copies of currently
approved consent forms must be maintained in the ERC adminisrative files.
Documentation of IRB approvals for pilot projects must be submitted as a
component of the Center annual progress report. “IRB approval” means full,
final IRB approval. In addition, all Center project protocols must comply with
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
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
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”
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
Although the financial plans of NIOSH provide
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
eligible to apply: Public nonprofit
organizations Private nonprofit
organizations For profit
organizations Small, minority, and
women-owned businesses Universities Colleges Research institutions Hospitals Community-based
organizations Faith-based
organizations Federally recognized or
state-recognized American Indian/Alaska Native tribal governments American Indian/Alaska
Native tribally designated organizations Alaska Native health
corporations Urban Indian health
organizations Tribal epidemiology
centers State and local
governments or their Bona Fide Agents (this includes the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the
Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the
Federated States of Micronesia, the Republic of the Marshall Islands, and
the Republic of Palau) Political subdivisions
of States (in consultation with States) 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.
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
disabilities are always encouraged to apply for CDC program support. 2. 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
1. Address to Request Application Information The current PHS 398 application instructions are
approved version of the PHS 398. For further assistance, contact PGO TIMS: Telephone
770-488-2700, Email: PGOTIM@cdc.gov
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
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
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
Face Page from the 398 application kit
Center Description, Performance Sites and Personnel. Form page 2
(use additional continuation pages as needed)
Detailed Budget for the Initial Budget period for the Entire
Budget for the Entire Proposed Period of Support for the Entire
Detailed Budget for the Administrative Core and Core Projects (Transdisciplinary
Projects and Education/Communication Projects ) for the Initial Budget period
(in the upper left margin, type the name of the project)
Budget for the Entire Proposed Period for Administrative Core
and Core Projects (in the upper left margin, type the name of the Project)
Biographical Sketch-Program Director/Principal Investigator
Overall Description of the Center (2 page maximum)
Past Performance/Accomplishments in last project period (existing
Center- 2 pages)
Past Performance/Accomplishments Relevant to Center Goals (new
applicants- (2 pages))
Statement on the Institutional Commitment to the Center (1 page
Human Subjects Summary Table that lists all the projects and
human subjects information (project title, performance sites, FWAs, IRB
approval date /status)
Administrative, Planning and Outreach Core Cover Sheet
Administrative , Planning and Outreach Core Description (Total of
25 pages including Outreach, Pilot Projects and Evaluation)
Outreach program Pilot Projects Evaluation Transdisciplinary, Exploratory, Efficacy, Effectiveness and
Evaluation Research Projects Cover Sheet Transdisciplinary, Exploratory, Efficacy, Effectiveness and
Evaluation Research Projects ( 25 total pages per project)
Research Project B (use as many headings as there are projects)
Education/Translation/Communication/Dissemination Core Cover sheet
Education/Translation/Communication/Dissemination Projects- (25 total
pages per project)
Note: Each Research Project A,B,C…) should use the following outline:
Header Page with Title and Program Director name (do not use a
398 Face page), Description, Performance Sites and Personnel (form page 2)
Highlights of Accomplishments for Past Project Period if it was
part of an existing Center of Excellence (1 page maximum
Preliminary Studies (for new applicants) Research Strategy (Significance, Innovation, Approach- (see
outline in 398 Instructions- page I-41)
Human Subjects (include enrollment form, inclusion of minorities,
Consortium/Contractual Arrangements 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).
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,
Dates(s): December 17, 2010 Peer Review
Date(s): March 2011 Council Review Date(s): May,
Letter of Intent Prospective applicants are asked to
information that it contains allows NIOSH staff to estimate the potential
The letter of intent should be sent to: Price Connor, Ph.D.
Applications to this FOA will be received at the
Center for Scientific Review, National Institutes of Health. Applications must
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
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.
date, the application may be delayed in the review process or not reviewed. Upon
responsiveness by the NIOSH. Incomplete and/or non-responsive applications will
HHS/CDC will not accept any application in response
Review Executive Order 12372 does not
5. Funding Restrictions All HHS/CDC awards are subject to the terms and
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".
outlined in the PHS398 Application Instructions are to be followed, with the
following additional requirements: Specific Aims is limited to 1
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
observe the required page limitations may not be considered in the review
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
HHS policy
community after publication (see the HHS Grants Policy Statement Investigators responding to this
each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting. Section
Criteria Only the review criteria described below will
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
Receive a second level of review by the NIOSH Secondary Review
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
review criteria, Review Criteria for Renewal Applications, and additional
review criteria (as applicable for the projects or programs proposed).
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
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?
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
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?
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
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.
criteria will also be applied to applications in the determination of
Review Criteria for the Administrative, Planning and Outreach
The following five scored review criteria will be used to
assess the APO Core:
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?
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?
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
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?
of Center Evaluation: Does the
application describe evaluation of scientific
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
assess Trans-disciplinary, Exploratory, Efficacy and Effectiveness Projects:
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?
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?
Criteria for Education, Translation, Communication and Dissemination Projects
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?
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
of scientific merit and the impact/priority score for Education, Translation,
Communication and Dissemination Projects:
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?
for Human Subjects. For research that involves human subjects but does not involve one of the
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.
of Women, Minorities, and Children. When the proposed project involves clinical research, the
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
Applications. When reviewing a Renewal application, the
committee will consider the progress made in the last funding period. Revision
2.B Additional
from Foreign Organizations. Not applicable.
Sharing Plans. HHS/CDC policy
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.
resources and data. The adequacy of the resources sharing plan will be
Progress Report (HHS/PHS 2590; http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.
and Period Support. Reviewers will consider whether the budget and the requested period of
determined by peer review Availability of funds Relevance of the proposed project to program priorities Geographic balance among the regions of the country
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.
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
the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. Additional requirements are available Section VIII. Other
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
local Governments are eligible to apply), and other HHS/CDC grant
funding instrument used for this program will be the cooperative agreement, an "assistance" instrument (rather than an
and activities may be shared among the awardees and the HHS/CDC may share
specific tasks and activities, as defined below.
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.
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 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
approval of annual summary report, advice and coordination consistent with
normal program stewardship for grants, as described below. This person will be responsible for
named in the Notice of Award (NoA). Responsibilities of the Program
Official include the following:
that all requirements are met prior to issuance of an initial award. Objectively
and independently evaluate progress toward specific aims or objectives,
approving non-competitive continuation of the award. Recommend
corrective actions as needed. Carry
out administrative duties e.g., grant cycle or funding information,
programmatic approvals and recommendations, consultation or technical
assistance pertaining to administration requirement of award, monitor
performance of the recipient, process Just-In-Time (JIT) information for
research projects, approve final reports before release and distribution,
communicate guidance and policy, facilitate budget recommendations,
program/site visit, dissemination of grantee information such as the
Annual Report and research reports.
IRB approvals as required by CDC when CDC is engaged in research involving
guidance or information for addressing recipient inquiries. Participate
in grantee meetings as a non-voting member; facilitate development of
goals and agenda for these meetings as necessary. NIOSH Project
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
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
NIOSH Project
Scientists will be named in the Notice of Award and will work closely with the
recipient and the NIOSH Program Official.
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
Dispute Resolution Any disagreements that may arise in
award recipients and the NIOSH may be brought to Dispute Resolution. A Dispute
members: a designee of the Steering Committee chosen without NIOSH staff
voting, one NIOSH designee, and a third designee with expertise in the relevant
Non-Competing Grant Progress Report, (use form PHS 2590, posted on the
HHS/CDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm, no less than
will serve as the non-competing continuation application. If you
would like to change reporting requirement (i.e. quarterly, semi-annual) see
instructions above and insert. Add Information here.
suitable for public distribution submitted to NIOSH/OEP Scientific Program
Invention Statement and Certification form
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
Contacts: Bernadine
Kuchinski, Ph.D.
of Extramural Programs Robert
A. Taft Laboratories,
4676 Columbia Pkwy. MS C-7
(513) 533-8511 FAX:
513-533-8564
bbk1@cdc.gov
2. Peer Review Contacts: Price Connor, Ph.D.
Clifton Road NE, MS E-74
404/498-2511
404/498-2571 (fax)
Financial or Grants Management Contacts: Maryann
& Assistance Field Branch
Box 18070, 626 Cochrans Mill Road
PA 15236-0070
Fax: (412) 386-6429 4.
General Questions Contacts: Technical Information Management Section
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.
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
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
of 45 C.F.R. Part 46, HHS Policy for the Protection of
Human Subjects. Therefore, proposals
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.
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
projects may require Institutional Review Board (IRB) approval or a certificate
HIV Program Review Panel
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
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/.
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.
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.
A. A copy of the face page of the application (PHS398). B. A summary of the project that should be titled "Public Health System
population to be served. A summary of the
services to be provided. A description of the
coordination plans with the appropriate state and/or local health
agencies. 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.
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
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
"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
participants to lobby or to instruct participants on how to lobby. In
legislature. Any
legislative bodies. The
and healthful environments.
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.
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."
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
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.
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.
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 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.
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
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:
Place small, minority,
women-owned business firms on bidders’ mailing lists. Solicit these firms whenever
they are potential sources of supplies, equipment, construction, or services. Where feasible, divide total
requirements into smaller needs, and set delivery schedules that will encourage
participation by these firms. Use the assistance of the
Minority Business Development Agency of the Department of Commerce, the Office
of Small and Disadvantaged Business Utilization, DHHS, and similar state and
local offices. Research Integrity
The signature of the institution official on the face page of the application
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
Section 93.301 Institutional assurances. (a) General policy. An institution
criteria as those for non-faith-based organizations in accordance with
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
direct financial assistance from DHHS under any DHHS program may not engage in
inherently religious activities, such as worship, religious instruction, or
programs or services will retain its independence from Federal, State, and local
organization=s name, select its board members on a religious basis, and include
religious references in its organization=s mission statements and other
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
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
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
In a timely manner. Completely, and as accurately
as possible. To facilitate the broader
community. Developed in accordance with
HHS/CDC policy on Releasing and Sharing Data. 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
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)
a. Section 106 of the National
Historic Preservation Act (NHPA) states: The head of any Federal agency, having direct or indirect
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
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