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Part I Overview Information

United States Department of Health and Human Services (HHS)

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

Components of Participating Organizations
Office of Public Health Research (OPHR/CDC), http://www.cdc.gov/od/science/PHResearch/)
Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER/CDC), http://www.cdc.gov/maso/pdf/COTPERfs.pdf
National Center for Injury Prevention and Control (NCIPC/CDC), (http://www.cdc.gov/ncipc/)
National Center for Environmental Health (NCEH/CDC), http://www.cdc.gov/nceh/default.htm
National Center for Health Statistics (NCHS/CDC), http://www.cdc.gov/nchs/
National Center for Health Marketing (NCHM/CDC), http://www.cdc.gov/healthmarketing/
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP/CDC), http://www.cdc.gov/nccdphp/
National Center on Birth Defects and Developmental Disabilities (NCBDDD/CDC), http://www.cdc.gov/ncbddd/
National Center for Immunization and Respiratory Diseases (NCIRD/CDC), http://www.cdc.gov/vaccines/about/default.htm
National Center for Zoonotic, Vector-Borne and Enteric Disease (NCZVED/CDC), http://www.cdc.gov/nczved/
National Center for HIV, Viral Hepatitis, STDs and Tuberculosis Prevention (NCHHSTP/CDC), http://www.cdc.gov/nchhstp/
National Center for Preparedness, Detection and Control of Infectious Diseases (NCPDCID/CDC) http://www.cdc.gov/ncpdcid/
National Institute for Occupational Safety and Health (NIOSH/CDC), http://www.cdc.gov/niosh/homepage.html
Office of Minority Health and Health Disparities (OMHD/CDC), http://www.cdc.gov/omhd/
Office of the Chief of Public Health Practice (OCPHP/CDC), http://www.cdc.gov/od/ocphp/

Title: Elimination of Health Disparities through Translation Research (R18)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement 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: Section 301 of the Public Health Service Act (42 U.S.C. Section 241), as amended and Sections 317(k)(1)&(2) of the Public Health Service Act [42 U.S.C. 247b(k)(1)&(2)], as amended, and the Occupational Safety and Health Act of 1970, Section 20(a) and 21(a) (29 USC 669(a) and 29 USC 670).

Announcement Type:
New

Update: The following update relating to this announcement has been issued:

Instructions for Submission of Electronic Research Applications:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)

A registration process is necessary before submission, and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Two steps are required for on time submission:

1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Standard Time on the application submission receipt date (see Key Dates below.)

2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.

Funding Opportunity Announcement (FOA) Number: RFA-CD-08-001

Catalog of Federal Domestic Assistance Number(s):
93.061, 93.262

Key Dates
Release/Posted Date: March 6, 2008
Open Date: April 2, 2008 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date: April 2, 2008
Application Submission Receipt Date(s): May 2, 2008
Peer Review Date(s): June/July 2008
Council Review Date(s): July 2008
Earliest Anticipated Start Date(s): September 2008
Expiration Date: May 3, 2008

Due Date for E.O. 12372

Executive Order 12372 does apply to this program.

Additional Overview Content

Executive Summary

Purpose. This funding opportunity announcement (FOA) encourages applicants to submit research grant applications that accelerate the translation of research findings into public health practice through implementation, dissemination, and diffusion research within health disparity populations.

Mechanism of Support. This FOA will use the Research Demonstration and Dissemination Projects (R18) award mechanism.

Funds Available and Anticipated Number of Awards. The participating organizations intend to commit a total of $ 4.5 million via the R18 mechanism for funding to applicants responsive to this announcement and whose projects are of high scientific merit and programmatic importance.

* 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 or for electronic applications, use a PDF file and attach as Other Documents and label as appropriate.

Funding Opportunity Announcement Glossary: FOA Glossary Terminology

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
2.Cost Sharing or Matching
3.Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
A. Receipt and Review and Anticipated Start Dates
1. Letter of Intent
B. Submitting an Application to CDC
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

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

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
A. Cooperative Agreement
1. Recipient Rights and Responsibilities
2. HHS/CDC Responsibilities
3. Collaborative Responsibilities
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

This funding opportunity announcement (FOA) is intended to solicit applications that support dissemination and implementation of public health research into public health practice activities in health disparity populations and to contribute to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This FOA addresses Healthy People 2010 priority area(s) of Prevention Research (Chapter 23, Section 17) and is in alignment with CDC’s performance goal(s) to support prevention research to develop sustainable and transferable community-based behavioral interventions.

Background

Health disparities have been documented for more than a century, yet efforts to eliminate them have been unsuccessful in many instances. The 2006 National Health Disparities Report provides evidence that disparities persist in nearly every aspect of health, including quality of health care, access to care, utilization of health care, clinical conditions including morbidity and mortality, and health care settings (Source: http://www.ahrq.gov/qual/nhdr06/nhdr06.htm). These disparities are evident in a diverse range of subpopulations that include individuals from various race/ethnic, gender, age, socio-economic, education, disability, and geographical regional groups. Despite the fact that these wide-spread health disparities have been documented and researched, there still remain significant improvements to be made in public health practice. This is due, in part, because the multi-factorial causes of these inequalities are inadequately understood and that a gap exists in knowledge as to the rationale for the limited or significantly delayed translation of promising evidence-based interventions that have been shown to be effective. Eliminating health disparities requires a resolute commitment to public health dissemination and implementation research.

Healthy People 2010, a comprehensive, national health promotion and disease prevention agenda developed by the U.S. Department of Health and Human Services (HHS), identified eliminating health disparities as a national goal.[1] In an effort to measure progress towards this national goal, Healthy People 2010 identified specific measurable objectives related to eliminating health disparities. A recently completed midcourse review of progress towards the goals and objectives of Healthy People 2010 found that while disparities for some objectives among some populations decreased, in many instances disparities failed to change and in some instances increased (Source: http://www.healthypeople.gov/data/midcourse/html/execsummary/Goal2.htm). This mixed progress towards the elimination of health disparities by race/ethnicity, income, education, and other social determinants of health during the first half decade magnifies the urgent need for collaborative research to accelerate progress during the remainder of the decade and beyond (Williams, 2005). (Source: Chapter 8, page 1). This FOA represents a critical step in moving effective interventions into practice and ultimately closing the gap on health disparities.

Through the formation of a Federal Collaboration on Health Disparities Research (FCHDR), CDC has engaged a wide range of federal partners (HHS agencies and non HHS department level agencies) to explore the complex nature of health disparities and the role research could play in accelerating positive impact on many of the long standing health disparities. The purpose of the Federal Collaboration is to reach across governmental agencies to identify the most important research needs, and opportunities, and establish a forum for collaboration that will help accelerate the elimination and prevention of health disparities. This FOA encourages applications focused in these four priority areas and/or one or more of the following additional FCHDR areas that are in support of the U.S. Department of Health and Human Services goals to reduce health disparities: 1) Cardiovascular disease, cancer, and diabetes; 2) Infant mortality, low birth weight, and disabilities; 3) Hepatitis, Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS), Sexually Transmitted Diseases (STDs), and tuberculosis (TB); 4) Immunizations and other Infectious Diseases; 5) Substance abuse and mental health; 6) Environmental health, occupational health; 7) Global health; and 8) Preparedness to achieve broad measurable and sustainable public health improvements. This FOA also solicits applications on specific priority topics of interest to CDC (listed later in this document), that support FCHDR s overall priority focus on translation research to eliminate health disparities

Clearly, there still remain significant improvements to be made in public health practice and this FOA represents one step in moving effective interventions into practice and ultimately closing the gap on health disparities. The CDC, in an effort to support the goals of the FCHDR, encourages innovative and interdisciplinary grant applications focused on translation research designed to eliminate and prevent health disparities.

Translation Research to Eliminate Health Disparities

Health disparities persist in many areas despite improvements in the health of the Nation as a whole. A critical knowledge base concerning the type and quality of services and programs that health disparity populations continue to receive coupled with socio-cultural differences such as lack of trust, language differences, and differences in attitudes, values, beliefs, and myths are barriers that contribute to the limited adoption of proven evidence-based public health interventions. In order to effectively reduce and/or eliminate these disparities, broad interventions at the systems level that focus on changing conditions at the community level rather than individual level is needed. Lessons learned from understanding and eliminating health disparities and improving health among health disparity populations will likely be applicable to the Nation as a whole.

Translation research broadly studies and examines factors that facilitate efficacious and effective translation of research into everyday public health policies and programs; evaluates the effectiveness of the administrative, management, policy, healthcare and public health practice decisions and/or use of research knowledge; and describes the experience and roles of the stakeholders, practitioners and participants. Previous efforts to accelerate the translation of research into public health practice and policy often fail to characterize the knowledge gap between evidence-based interventions and effective delivery; have not sufficiently evaluated the factors necessary for the successful adaptation of interventions or supporting infrastructure; and typically have not described the requirements for stakeholders collaboration to facilitate meaningful adoption by the target population or potential for broader public health uptake. Likewise, dissemination of an intervention alone (e.g. guideline publication) is often insufficient to change practice habits and result in health benefits. However, recent attention and support from several federal agencies (e.g. NIH, AHRQ, CDC, VA) and research foundations (e.g. the Robert Wood Johnson Foundation, William T. Grant Foundation) are helping to build a robust body of evidence in the field of public health translation research that will help fill knowledge gaps and move the field forward.

CDC’s ultimate goal is to increase the spread and usage of effective public health interventions based on science that works so that the greatest health impact for an individual, community or nation can be achieved with the greatest efficiency. Likewise, CDC aims to eliminate health disparities for vulnerable populations as defined by race/ethnicity, socio-economic status, geography, gender, age, disability status, risk status related to sex and gender, and among other populations identified to be at-risk for health disparities. Through this FOA, CDC intends to accelerate the translation of research findings into public health practice through dissemination, implementation, and diffusion research to ultimately eliminate health disparities and to inform decision-making at the public health, organization/health care systems, and/or public policy levels.

Proposed health disparity translation research studies should identify one or more of the following: 1) factors that inhibit or facilitate the translation of evidence-based public health interventions, policies, recommendations, etc.; 2) methods and tools for the successful translation of evidence-based programs, practices, or policies that retain fidelity, and achieve positive outcomes for target populations; and 3) optimal strategies to enhance the widespread adoption and institutionalization of effective public health intervention programs, including the adaptability of interventions to other and larger health disparity populations. Applicants should focus on the translation of existing evidenced-based programs, practices, policies, recommendations, tools, and/or strategies and are encouraged to use existing resources of proven effective interventions such as The Guide to Community Preventive Services (The Community Guide) and the Guide to Clinical Preventive Services . Wherever possible, studies that are interdisciplinary and include collaborations with traditional and non-traditional stakeholders that serve health disparity populations as a primary component of their mission are encouraged.

Definition of Terms

For information of translation research terminology relevant to the FOA, please see the section called Definition of Terms under Research Objectives at the following link: http://grants.nih.gov/grants/guide/rfa-files/RFA-CD-07-005.html

CDC Coordinating Office, National Center, or Institute (CO/NC/I) Research Priorities

Listed below are specific priority topics of interest to CDC that support FCHDR’s overall priority focus on translation research to eliminate health disparities. Applications submitted in response to this funding announcement must identify the FCHDR and Coordinating Office, National Center, or Institute (CO/NC/I) priority area(s) the application is responding to. Each application will compete for available funds with all other eligible applications. Applications that do not identify and align with any of the FCHDR and CO/NC/I priorities and do not address the submission requirements in Section IV.3.C. will be considered non-responsive.

The mission of the National Center for Injury Prevention and Control (NCIPC) is to save lives and reduce the number and severity of unintentional and violence related injuries. The CDC Injury Research Agenda (http://www.cdc.gov/ncipc/) encompasses: acute injury care, disability and rehabilitation; prevention of home, sports, transportation and community injuries; and prevention of youth violence, intimate partner and sexual violence, child maltreatment and suicidal behavior. Disparities in risk of injury and severity of outcome, the latter often related to timely access to quality acute care, vary across many causes of injury and at-risk populations. Those listed below are injury topics with known effective interventions and thus of highest priority to NCIPC.

Child Maltreatment or Youth Violence Prevention: Child maltreatment affects 14% of U.S. children and highest rates occur among African Americans, American Indians or Alaskan Natives, and Pacific Islanders. Youth violence is the second leading cause of death for ages 10-24. Priorities include studies aimed at identifying and evaluating efficient and effective methods for the dissemination and implementation of evidence-based interventions, programs, and policies to prevent either the perpetration of or victimization from child maltreatment or youth violence. To accelerate the widespread use of effective programs in populations disproportionately impacted by child maltreatment or youth violence, research may: examine the optimal ways to synthesize, translate, and package effective prevention approaches; address impediments and facilitators to program adoption and sustained use; examine ways to build individual and organizational capacities to use effective approaches (i.e., understanding the type and quality of technical assistance training, coaching, monitoring necessary to support effective implementation); study how individual, organizational and community characteristics influence the adoption and effective use of empirically-supported violence prevention approaches; and once an effective approach is adopted, understanding the effects of implementing the program, policy, or practice as originally developed (i.e., with fidelity ), as opposed to changing the content or delivery format (i.e., adapting ).

Translating Alcohol-Related Preventive Clinical Services into Routine Emergency Care: Risky drinking is now the leading risk factor for serious injury in the United States, and the third leading cause of preventable death. It accounts for more than $180 billion annually. Higher rates of drunk driving are associated with lower per capita income households. Brief screening and counseling interventions in emergency departments and trauma centers has been effective in decreasing excessive drinking, impaired driving, and hospital admissions. Research is needed to determine the barriers and facilitators to implementing effective brief alcohol screening and interventions in areas with lower income in order to achieve maximum results and determine whether targeting or intensifying training in impoverished neighborhoods would achieve a greater reduction in drunk driving.

Community Interventions to reduce motor vehicle injuries: Several known effective community interventions to decrease alcohol impaired driving face barriers to effective implementation. Research is needed to identify a) the most effective means of disseminating research findings about effectiveness to groups that want to implement interventions and b) the role community coalitions can play in removing barriers to implementing these interventions. Research is needed to address barriers impeding effective implementation of seat belt use interventions, including but not limited to determining a) how communities can increase public acceptance of primary safety belt laws and b) whether enhanced enforcement programs divert police from other crimes.

The National Center for Environmental Health (NCEH), http://www.cdc.gov/nceh/default.htm, plans, directs, and coordinates a national program to maintain and improve the health of the American people by promoting healthy environments and by preventing premature death and avoidable illness and disability caused by non-infectious, non-occupational environmental and related factors. The following topics are of the highest priority to NCEH:

Healthy Homes and Communities: Certain populations face a disproportionate risk for exposures to environmental hazards in their homes and/or in the communities where they live. Interventions are needed to address disparities in health outcomes related to living conditions at the scale of homes (e.g., vector control, lead paint removal, mold control, carbon monoxide detectors, and fall hazard abatement) and/or communities (e.g., exposures to environmental substances or other environmental hazards, mixed land use, activity centers, pedestrian infrastructure, appropriate residential density, greenspace, mass transit). Priorities include:

Climate Change: Climate change affects public health directly through the propagation of extreme temperatures, in particular heat waves. Research is needed to identify facilitators and impediments to applying proven existing mitigation and adaptation interventions more broadly in public and private sectors, and to develop strategies to reach populations with disproportionate risks for climate-related adverse health outcomes. Priorities include:

Asthma: Research has shown that ethnic and/or low-income populations have an increased risk for morbidity and mortality from asthma and asthma-related conditions. Research is needed to translate proven interventions for improved asthma management to reduce disparate outcomes among at-risk population. Priority research topics that address disparities in asthma management include:

The National Center for Immunization and Respiratory Diseases (NCIRD), http://www.cdc.gov/vaccines/about/default.htm, prevents disease, disability, and death through immunization and by control of respiratory and related diseases. Projects should focus on the following priority:

The National Center for Zoonotic, Vector-Borne, and Enteric Diseases (NCVZED), http://www.cdc.gov/nczved/, maximizes public health and safety nationally and internationally through the prevention and control of disease, disability, and death caused by zoonotic, vector-borne, foodborne, waterborne, mycotic, and related infections. Projects should focus on the following priority:

The National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), http://www.cdc.gov/nchhstp/, maximizes public health and safety nationally and internationally through the elimination, prevention, and control of disease, disability, and death caused by Human Immuno-deficiency Virus Infection/Acquired Immunodeficiency Syndrome, Non-HIV Retroviruses, Viral Hepatitis, other Sexually Transmitted Diseases, Tuberculosis, and Non-Tuberculosis Mycobacteria. Projects should focus on the following priority:

The National Center for Preparedness, Detection, and Control of Infectious Diseases (NCPDCID), http://www.cdc.gov/ncpdcid/, protects populations domestically and internationally through leadership, partnerships, epidemiologic and laboratory studies, and the use of quality systems, standards, and practices. NCPDCID collaborates with the Coordinating Center for Infectious Diseases (CCID), CDC, and the agency’s national and global partners to conduct, coordinate, and support infectious disease surveillance, research, and prevention. Projects should focus on the following priority:

The mission of the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), http://www.cdc.gov/nccdphp/, is to prevent death and disability from chronic diseases; to promote maternal, infant, and adolescent health; to promote healthy personal behaviors; and to accomplish these goals in partnership with health and education agencies, voluntary associations, the private sector, and other federal agencies. NCCDPHP places high priority on chronic diseases and conditions and reproductive health outcomes that have the greatest impact on health, longevity, and quality of life, especially those related to gender, age, race/ethnicity, geography, sexual orientation, socioeconomic status, disability, and special needs.

NCCDPHP is interested in research that develops and tests models for translation, dissemination, and implementation of effective programs/policies that utilize a community-partnered approach to promote health and prevent disease and eliminate health disparities. Research projects should identify methods that can be implemented at the individual, family, community, and organizational levels that will accelerate the adoption of programs, policies, and behaviors aimed at reducing chronic diseases and conditions and adverse reproductive health outcomes. Projects should focus on the following priorities:

The National Center on Birth Defects and Developmental Disabilities (NCBDDD), http://www.cdc.gov/ncbddd/, promotes the health of babies, children, and adults, and enhances the potential for full, productive living. Projects should focus on translation research related to the following priorities:

The National Center for Health Statistics (NCHS), http://www.cdc.gov/nchs/, supports statistical and epidemiological activities for the purpose of improving the effectiveness, efficiency, and quality of health services for populations at risk in the United States. This includes collecting statistics on illness and disability of the population and its impact on population well-being, e.g. the U. S. economy; health resources, including health professionals and services; utilization of health care and facilities; health care costs and financing, including trends in prices and cost, sources of payments, and governmental expenditures; family formation, growth, and dissolution.

NCHS continues to be interested in the use of NCHS data sets to explore the disparities in the penetration of health policies and recommendations through a variety of population subgroups including various minority groups, rural populations and economically disadvantaged populations. NCHS data can provide information on diseases or conditions found in the priority areas of:

The mission of the National Center for Health Marketing (NCHM),

http://www.cdc.gov/healthmarketing/, is to protect and promote health and advance CDC’s goals through innovative health marketing programs, products, and services that are customer-centered, high-impact, and science-based. Health marketing and communication is an emerging field that draws from traditional marketing theories and principles. Health marketing is defined as creating, communicating and delivering health information and interventions using customer-centered and science based strategies to protect and promote the health of diverse populations. NCHM helps define the future of health marketing within CDC, the federal sector and beyond.

The following topics are of the highest priority to NCHM:

Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER)

The Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER), http://www.cdc.gov/maso/pdf/COTPERfs.pdf, has primary oversight and responsibility for all programs that comprise CDC's terrorism preparedness and emergency response portfolio. Through an all-hazards approach to preparedness that focuses on threats from natural, biological, chemical, nuclear, and radiological events, COTPER helps the nation prepare for and respond to urgent threats to the public's health. COTPER’s mission is to prevent death, disability, disease and injury associated with urgent health threats by improving preparedness of the public health system, the healthcare delivery system and the public through excellence in science and services.

Special consideration will be given to funding research that develops and tests models for translation, dissemination, and institutionalization of best practices and evidence-based practices within health disparity populations and that addresses the following priority:

National Institute for Occupational Safety and Health (NIOSH)

The U.S. workforce is becoming increasingly diverse due to the changing demographic characteristics of the country. One out of two new U.S. workers in the past decade was born outside the country. Many of these foreign-born workers are immigrants with modest educational backgrounds and low English proficiency. These demographic changes in the U.S. workforce have been accompanied by a reduction in job security and an expansion of contingent 1 employment, including temporary and part-time employment. Current research indicates that these demographic and workplace changes have created health disparities among foreign-born and contingent workers in the rates of work-related illnesses and injuries. These disparities are due in part to the expansion of low-income and racial and ethnic minority workers in the most hazardous industries and occupations. While proven occupational safety and health interventions exist, their penetration into certain at-risk worker populations has not been adequately realized, particularly into populations of foreign-born workers and contingent workers. Consequently, NIOSH is interested in research that addresses the dissemination, implementation, and diffusion of proven interventions (e.g., best practices, programs, policies, and behaviors) that reduce or prevent occupational injuries and illnesses among populations of contingent workers, as well as foreign-born workers. This interest is consistent with the framework of CDC's Healthy Workplace goal and the National Occupational Research Agenda (NORA).

For this announcement, NIOSH solicits translation research applications that address health disparities among either foreign-born or contingent workers in the following NORA industrial sectors (http://www.cdc.gov/NIOSH/NORA/sector.html):

1Contingent Worker: A temporary or part-time worker, usually one working under contract for a fixed period or a specific project. This includes day laborers, migrant agricultural workers, fast food service workers, and housekeeping services workers.

Office of Minority Health and Health Disparities (OMHD)

The Office of Minority Health and Health Disparities (OMHD), www.cdc.gov/omhd/, in collaboration with CDC’s National Centers aims to accelerate health impact in the U.S. population and to eliminate health disparities for vulnerable populations as defined by race/ethnicity, socio-economic status, geography, gender, age disability status, risk status related to sex and gender, and among other populations identified to be at-risk for health disparities. Some key OMHD activities include 1) developing CDC-wide health disparities elimination strategies, policies, goals, and programs; 2) supporting partnerships to advance the science, practice, and workforce for eliminating health disparities; and 3) synthesizing, disseminating, and encouraging the use of scientific evidence about effective interventions to achieve health disparities elimination outcomes. OMHD is interested in translation research that can improve the health of minority or other populations experiencing health disparities and can eliminate health disparities in the United States.

The following topics are of the highest priority to OMDH:

Office of the Chief of Public Health Practice

The Office of the Chief of Public Health Practice (OCPHP), http://www.cdc.gov/od/ocphp/index.htm, provides leadership to ensure that the public health system, i.e., the "practice of public health", is strengthened through performance improvement at the federal, tribal, state, and local levels in order to meet current and emerging health protection and promotion priorities. OCPHP is the hub of the scientific effort to improve performance in the practice of public health (by CDC and by a wide spectrum of extramural organizations). Special consideration will be given to the following research priority:

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

Section II. Award Information

1. Mechanism(s) of Support

This FOA will use the Research Demonstration and Dissemination Projects (R18) award mechanism.

The R18 mechanism provides support to develop, test, and evaluate health service activities, and to foster the application of existing knowledge for the control of categorical diseases.

2. Funds Available

The CDC intends to commit approximately $4.5 million in total cost dollars in FY2008 to fund approximately 9 applications. The average award amount will be approximately $350,000-$450,000 including direct and indirect costs per 12 month budget period (e.g., direct and indirect costs). An applicant may request a project period of up to 3 years. An applicant may request up to $450,000 including direct and indirect costs for each budget year. The approximate range for total project period (3 years) is $1,050,000 to $1,350,000 including direct and indirect costs. The anticipated start date for new awards is September 2008.

All estimated funding amounts are subject to availability of funds.

If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the CIO (s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

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

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 or for electronic applications, use a PDF file and attach as Other Documents and label as appropriate.

Note: Applications will not be accepted from foreign institutions. Applicants wishing to form foreign collaborations may do so as long as the primary domestic grant recipient performs a substantive role in the project and is not acting solely as a conduit to another party.

2. Cost Sharing or Matching

This program does not require cost sharing or matching.

3. Other-Special Eligibility Criteria

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

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at the following:

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact PGO TIMS: Telephone 770-488-2700, Email: [email protected].

HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by HHS/CDC (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Tips and Tools for Navigating Electronic Submission on the front page of Electronic Submission of Grant Applications.

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, mandatory and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the CDC R18 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date: April 2, 2008 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date: April 2, 2008
Application Submission Receipt Date(s): May 2, 2008
Peer Review Date(s): June/July 2008
Council Review Date(s): July 2008
Earliest Anticipated Start Date(s): September 2008

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program 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:

Juliana Cyril, Ph.D.
Office of Public Health Research
CDC Office of the Chief Science Officer
1600 Clifton Rd., MS D-72
Atlanta, GA 30333
Telephone: (404) 639-4639
Fax: 404-639-4903
Email: [email protected]

3.B. Submitting an Application to CDC

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow steps 1-4. Note: Applications must only be submitted electronically. PAPER APPLICATIONS WILL NOT BE ACCEPTED.

3.C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Standard Time on the application submission date(s) described above (Section IV.3.A.). If HHS/CDC receives an application after that submission date and time, the application will not be reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness and responsiveness by Office of Public Health Research and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.

All applicants must address the following requirements in their applications. Applicants that do not address items I-V below will be considered non-responsive. Specifically, applicants must address the following in their Research Plan:

I. Relevant CDC Coordinating Office, National Center, or Institute

Applications submitted in response to this funding announcement must identify the FCHDR and Coordinating Office, National Center, or Institute (CO/NC/I) priority area(s) the application is responding to. 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 the Office of Public Health Research or participating National Centers, Institutes, and Offices. Each application will compete for available funds with all other eligible applications. Applications that do not identify and align with any of the FCHDR and CO/NC/I priorities listed in Section I. will be considered non-responsive.

II. Study Approach and Documentation of Scientific Evaluation of Intervention

An intervention is an intentional action (singular or constellation) designed for an individual, a community, or a region that alters a behavior, reduces risk or improves outcome. Interventions should be evidence-based, may have a medical or behavioral focus, and may consist of a modification to the natural or built environment, engineering controls, public heath policy, public health program, health communication, or public health law. Evidence-based means that the intervention has undergone sufficient scientific evaluation to be proven to be efficacious or effective (e.g., intervention is considered valid or proven because it is strongly linked to desirable outcome). Scientific evaluation might include but is not limited to peer review publications of 1) quantitative or qualitative research; 2) evaluation reports; 3) systematic reviews of the literature (e.g., meta-analysis) or 4) descriptive or survey research. Applicants should document the appropriate information that substantiates that the intervention has undergone sufficient scientific evaluation to be considered evidence-based.

Research projects submitted can approach the topics of focus in this FOA through the analysis of major data sets that include information on the translation of health recommendations or policies through various populations and the factors that inhibit or facilitate that penetration. For applicants proposing to study policies/regulations/laws and/or conduct secondary data analysis, the underlying scientific evidence and evaluation that lead to the policy or recommendation under study must be adequately described.

III. Target Population to be Studied

The target population should be well-defined and a justification for the health disparity population(s) chosen should be included. Applicants should present a clear understanding of population characteristics, demographics, and health status. The information needs of the target population, and the barriers as well as available resources, should be understood and well described. The portion of target population to be reached by the project should be identified.

IV. Assessing and Reporting the Intervention s Translatability

Applicants must include a plan to estimate and report the potential translatability and public health impact of the intervention. If appropriate, the plan should include methodology to measure the interplay between fidelity, the necessary adaptation of the intervention, and scalability. Novel evaluation models are acceptable with justification or applicants may elect to use but are not limited to previously published models and frameworks. Key translation research questions to consider in the plan:

V. Community Action Plan (CAP)

Applicants must include a Community Action Plan that demonstrates a clear understanding of the stakeholders roles and incentives; factors that influence decision-making for stakeholders, implementers and target population (e.g., training); and the organizational capacity (e.g., need and fit for the proposed intervention). Broad stakeholder involvement should be outlined from the outset to include traditional and non-traditional research partners (e.g., federal/state or local government, education, community, public policy, politicians, private sector, non-profits, health systems, academics, coalitions and media). Detailed, complete and substantive plans for ensuring the meaningful involvement of partners and stakeholders must be included in applications responsive to this FOA. Note: Projects that propose to conduct secondary data analysis do not have to submit a community action plan.

There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments.

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

4. Intergovernmental Review

Executive Order 12372 does 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 Grants Policy Statement at:

http://pgo.cdc.gov/pgo/webcache/policy/HHS GPS Oct 2006.doc.

Restrictions, which applicants must take into account while writing their budgets, are as follows:

Note: Applications from foreign institutions will not be accepted.

6. Other Submission Requirements

The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs Important Tips -- Electronic Submission of Grant Applications.

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments. Your research plan must not exceed 25 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants 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.

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 25 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 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 at: http://pgo.cdc.gov/pgo/webcache/policy/HHS GPS Oct 2006.doc.) 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

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened for the priority areas of the participating Coordinating Offices, National Centers, or Institute (CO/NC/I) in accordance with the review criteria stated below.

The peer review of all applications consists of the following:

Applications submitted in response to this funding announcement must identify the FCHDR and Coordinating Office, National Center, or Institute (CO/NC/I) priority area(s) the application is responding to. Each application will compete for available funds with all other eligible applications. Applications that do not identify and align with any of the FCHDR and CO/NC/I priorities and do not address the submission requirements in Section IV.3.C. will be considered non-responsive. The criteria listed below and in Section V.1. will be considered in making funding decisions:

The goals of HHS/CDC-supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness. In the written comments, evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed by the reviewers and considered in assigning the overall score, weighting them and weighted, as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the applicant achieves the aims of the application, how will it advance scientific knowledge or clinical practice? What will be the effect of these studies on the concepts, methods, technologies, treatments, or preventative interventions that drive this field? How will these research findings improve our understanding of the gap between knowledge and public health practice? Does this new understanding aid future dissemination, implementation or diffusion efforts of evidence-based public health interventions to result in the greatest public health impact?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the key variables for translation research included and sufficiently described? Has the applicant adequately documented that the intervention, policy, etc. is evidence-based? Has the applicant described and justified the target health disparity population(s) sufficiently? Is there a plan for estimating translatability and public health impact? Is there a community action plan that is appropriate to the aims of the project and involves key stakeholders and partners? (Community actions plans not relevant for studies conducting secondary data analysis)

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

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

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

2.A. Additional Review Criteria

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

Protection of Human Subjects from Research Risk: When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research. (see the Research Plan, Section 2, item 8 on Human Subjects in the SF424 (R&R) available at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). 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 and Minorities in Research: Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research? This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits (see Section 2, item 9 Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If applicants plan to use vertebrate animals in the project, HHS/CDC will assess the five items described under Section 2, item 1211 Vertebrate Animals of the Research Plan component of the SF424 (R&R). Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Biohazards: If applicants propose the applicant has proposed materials or procedures that are potentially hazardous to research personnel and/or the environment, HHS/CDC will determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods? The evaluation of the budget should not effect the priority score.

2.C. Sharing Research Data

Data Sharing Plan: HHS/CDC will assess the reasonableness of the data sharing plan. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

HHS/ PHS 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://grants.nih.gov/grants/policy/gps/8postnew.htm#phs. Investigators responding to this funding opportunity should include a plan on sharing research resources.

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

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. 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.

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 applicant organization will receive a written critique called a Summary Statement. The applicant organization and the PD/PI will be able to access the Summary Statement via the eRA Commons.

HHS/CDC will contact those applicants under consideration for funding for additional information.

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 (GMO) is the authorizing document. HHS/CDC will mail and/or e-mail this document to the recipient fiscal officer identified in the application.

Selection of the application for award is not an authorization to begin performance. Any cost incurred before receipt of the NoA is at the recipient’s risk. Pre-award costs will not be reimbursed. 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 in 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 courtesy copy to the PD/PI at the time of award.

3. Reporting

Recipient Organization must provide HHS/CDC with an original, plus two hard copies of the following reports:

1. Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHSCDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm,) no less than 90 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

Recipient Organization must forward these reports by the U.S. Postal Service or express delivered to the Grants Management Specialist listed in the Agency Contacts section of this NoA.

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.

Section VII. Agency Contacts

HHS/CDC encourages your inquiries concerning this FOA and welcomes the opportunity to answer questions from potential applicants. Inquiries can fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

For general scientific questions concerning this FOA, please contact Juliana Cyril (OPHR). For specific scientific questions concerning the research topics listed in this FOA, please contact the individual identified below for the corresponding CDC organizational unit. Please note that Juliana Cyril, will serve as the point-of-contact for the CDC organizational units which do not list a specific scientific contact individual (e.g. NCHM, OMHD and OCPHP).

Juliana Cyril, Ph.D., M.P.H.
Associate Director for Policy and Peer Review
Office of Public Health Research
CDC Office of the Chief Science Officer
Also serves as contact for NCHM, OMHD and OCPHP
1600 Clifton Road NE, MS D-72
Atlanta, GA 30333
Telephone: (404) 639-4639
Fax: 404-639-4903
Email: [email protected]

Rick Waxweiler, Ph.D.
Director
Extramural Research Program Office
National Center for Injury Prevention and Control (NCIPC)
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS K-02
Atlanta, GA 30333
Telephone: 770-488-4850
Fax: 770-488-4422
Email: [email protected]

Adele Childress, Ph.D.
Scientific Program Administrator
National Center for Environmental Health (NCEH)
Agency for Toxic Substance and Disease Registry (ATSDR)
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS F-62
Atlanta, GA 30333
Telephone: 770-488-4233
Fax: 770-488-1665
Email: [email protected]

Virginia S. Cain, Ph.D.
Director of Extramural Research
National Center for Health Statistics (NCHS)
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS P-08
Atlanta, GA 30333
Telephone: 301-458-4395
Fax: 301-458-4020
Email: [email protected]

Brenda Colley-Gilbert, Ph.D. M.S.P.H.
Director, Extramural Research
Coordinating Center for Health Promotion (CoCHP)
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)
National Center on Birth Defects and Developmental Disabilities (NCBDDD)
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS K-92
Atlanta, GA 30333
Telephone: 770-488-6295
Fax: 770-488-8488
Email: [email protected]

Brian W.J. Mahy, M.A. Ph.D. Sc.D.
Director (acting), Extramural Research
Coordinating Center for Infectious Diseases (CCID)
National Center for Immunization and Respiratory Diseases (NCIRD)
 National Center for Zoonotic, Vector-Borne and Enteric Disease (NCZVED)
National Center for HIV, Viral Hepatitis, STDs and Tuberculosis Prevention (NCHHSTP)
National Center for Preparedness, Detection and Control of Infectious Diseases (NCPDCID)
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS C-12
Atlanta GA 30333
Telephone: 404-639-2915
Fax: 404-639-2469
Email: [email protected]

Wilbert J. Newhall, Ph.D.
Director, Office of Extramural Programs
National Institute for Occupational Safety and Health (NIOSH)
Centers for Disease Control and Prevention
1600 Clifton Road, NE, MS E-74
Atlanta, GA 30333
Phone: 404-498-2530
Fax: 404-498-2571
E-mail: [email protected]

Mildred William Johnson, Ph.D., D.A.B.T.
Scientific Program Administrator
Coordinating Office for Terrorism Preparedness and Emergency Response (COTPER)
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS D-44
Atlanta, GA 30333
Telephone: 404-639-7719
Fax: 404-639-7977
Email: [email protected]

2. Peer Review Contacts:

Maurine Goodman, M.P.H., M.A.
Office of Public Health Research
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS D-72
Atlanta, GA 30333
Telephone: 404-639-4737
Fax: 404-639-4903
Email: [email protected]

3. Financial or Grants Management Contacts:

Mattie Jackson
CDC Procurement and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road NE
Atlanta, GA 30341
Telephone: (770)-488-2696
FAX: 770-488-2044
Email: [email protected]

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 Person 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 an extramural research plan, 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.

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.

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

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 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 awardee 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:

1. Place small, minority, women-owned business firms on bidders mailing lists.

2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.

3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.

4. 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 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/.

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:

a. In a timely manner.

b. Completely, and as accurately as possible.

c. To facilitate the broader community.

d. Developed in accordance with 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, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) www.4.law.cornell.edu/uscode/5/5/552/html.
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. 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.

Conference Disclaimer and Use of Logos

Disclaimer: Where a conference is funded by a grant or cooperative agreement, a subgrant 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.

[1] U.S. Department of Health and Human Services. (2000). Healthy People 2010: Understanding and improving health. Retrieved March 15, 2007, from http://www.healthypeople.gov/Document/tableofcontents.htm#under

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