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/)
Agency for Toxic Substances and Disease Registry (http://www.atsdr.cdc.gov)

Components of Participating Organizations
Office of Public Health Research (OPHR/CDC), http://www.cdc.gov/od/science/PHResearch/)
Coordinating Office for Global Health (COGH/CDC), http://www.cdc.gov/cogh/
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 Office of Public Health Genomics (NOPHG/CDC), http://www.cdc.gov/genomics/
National Center for Immunization and Respiratory Diseases (NCIRD/CDC)
National Center for Zoonotic, Vector-Borne and Enteric Disease (NCZVED/CDC)
National Center for HIV, Viral Hepatitis, STDs and Tuberculosis Prevention (NCHHSTP/CDC)
National Center for Preparedness, Detection and Control of Infectious Diseases (NCPDCID/CDC)
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: Improving Public Health Practice through Translation Research (R18)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement may 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 applicants will be directed elsewhere for that information.

Authority: Sections 301 and 317(k)(2) of the Public Health Service Act [42 U.S.C. 241 and 247b(k)(2)], and Section 104(i) of the Comprehensive Environmental Response, Compensation and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604(i)].

Announcement Type
New

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. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT

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 highly 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-07-005

Catalog of Federal Domestic Assistance Number(s)
93.061

Key Dates
Release Date:  February 16, 2007
Letter of Intent Receipt Date: March 12, 2007
Application Submission Receipt Date(s): April 10, 2007
Peer Review Date(s)June 2007
Council Review Date(s): June/July 2007
Earliest Anticipated Start Date(s): September 2007
Additional Information to Be Available Date: Not applicable
Expiration Date: April 11, 2007

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

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
        B. Eligible Investigators
    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

The CDC within HHS is committed 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 RFA 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. For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.

The purpose of this RFA is the achievement of new scientific knowledge that can accelerate the translation of research findings into public health practice through implementation, dissemination, and diffusion research. The specific objective of the RFA is to conduct translation research using an evidence-based intervention or policy. Proposed research should identify: 1) impediments and/or facilitators to the successful translation of evidence-based public health intervention(s); 2) methodological tools for the successful translation of evidence-based programs, practices, or policies; that retain fidelity, and achieve positive outcomes for target populations; or 3) optimal strategies to enhance the widespread adoption and institutionalization of effective public health intervention programs.

Background

The Center for Disease Control and Prevention (CDC) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and the “CDC Health Protection Goals” while measuring program performance as stipulated by the Government Performance and Review Act (GPRA).  This RFA addresses “Healthy People 2010” priority area(s) of Educational and Community-Based Programs and is supportive of CDC’s Health Protection four overarching Goals regarding healthy people, healthy places, preparedness, and global health.  These Goals create the framework to increase the capacity to accelerate health impact and reduce health disparities. For more information, see www.health.gov/healthypeople, http://www.cdc.gov/about/goals and www.whitehouse.gov/omb/mgmt-gpra/.

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.  While the benefit of public health interventions correlates with its efficacy and effectiveness, the greatest health impact on individuals, the community, racial/ethnic and other populations experiencing health disparities, and the broader population is achieved when an evidence-based intervention is optimally translated into public health practice and policy.  This process is complex, dynamic and frequently non-linear.  Lessons learned from successful translation should feedback into the discovery science that formulated the intervention. This bi-directional translation of research knowledge (i.e., intervention) to practice and back to science can be defined as the “exchange, synthesis, and application of knowledge between researchers, public health professionals, policy makers, and consumers/users in order to obtain the benefits of research through improved health (Davis 2003).” Amidst increasing demand for services and decreasing budgets, translation into public health practice may be more likely to occur if it is based on high quality evidence.  Greater attention to the practice of evidence-based public health has resulted in practice guidelines such as “The Guide to Community Preventive Services (The Community Guide) and the Guide to Clinical Preventive Services (Maibach 2006).  These resources synthesize a body of evidence and offer guidance for public health program decision making at the local, state, tribal and national levels. Such guidelines play a role in shaping public health decisions, and also inform decisions outside the public health system, including decisions made by employers, local communities and organizations, and even individual consumers (Maibach 2006).  A thriving partnership between evidence-based medicine and public health enhances this process (Briss 2005)

Although most researchers develop evidence-base interventions for public health practice the rate of adoption and implementation is low due to uncharacterized impediments. The Institute of Medicine (IOM) highlighted a parallel problem for clinical medicine in its report Crossing the Chasm: A New Health System for the 21st Century in which it summarized the difficulty of effective implementation and diffusion of proven healthcare interventions (Glasgow 2003).  The existence of relevant and high quality research findings does not in itself assure good practice.  This gap between knowledge generation and use or application is particularly problematic (Johnson 1996) because despite extensive research on the efficacy and effectiveness of health promotion and disease prevention intervention strategies, little is know regarding effective methods for the broader dissemination, adoption, and implementation of these interventions (Oldenburg 1999). In order to improve translation of research findings into public health practice it is important that the following elements are incorporated into translation studies; research incentives and policies, organizational and structural support, appropriate and targeted funding, formal monitoring and evaluation of the activity and its dissemination and impact, ongoing training for both researchers and practitioners, appropriate engagement with the target population, and a clear process for stakeholder selection, interaction and collaboration (Oldenburg, 1996).

Research Objectives

The purpose of this RFA is to accelerate the translation of research findings into public health practice through implementation, dissemination, and diffusion research; these terms are defined below. The specific objective of the RFA is to conduct translation research using an evidence-based intervention or policy. Proposed research should identify: 1) impediments and/or facilitators to the successful translation of evidence-based public health intervention(s); 2) methodological tools for the successful translation of evidence-based programs, practices, or policies that retain fidelity, and achieve positive outcomes for target populations; or 3) optimal strategies to enhance the widespread adoption and institutionalization of effective public health intervention programs.

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.  Practitioners, researchers and public health policy makers must work together to ensure that evidence-based public health interventions are successfully implemented for a significant, sustained and measurable health impact. 

Previous efforts to accelerate the translation of research into public health practice and policy often have not satisfactorily characterized the knowledge gap between evidence-based public health 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.  Dissemination of an intervention alone (e.g., guideline publication) is often insufficient to change practice habits and result in health benefit.

Definition of Terms

According to CDC, for the purpose of this RFA, the following terminology is defined:

Evidence-based interventions are a key component of translation research. Therefore, for the purposes of this RFA it is important to define and describe the characteristics of an evidence-based intervention:

In the context of an intervention it is extremely important to clarify the concept of “adaptation”, “adoption”, “fidelity”, “outcomes and impacts”, ”scalability” and sustainability which are interrelated and not mutually exclusive terms.

Research Scope

CDC has developed strategic imperatives and Health Protection Goals that create the framework to increase the capacity to accelerate health impact and reduce health disparities. CDC is committed to achieving meaningful improvements in people’s health and has defined specific Health Protection Goals to prioritize and focus its work and investments and measure progress. CDC has developed four overarching Health Protection Goals for healthy people, healthy places, preparedness, and global health. Each overarching Goal is associated with several more specific strategic Goals. (See http://www.cdc.gov/about/goals for additional information about CDC’s Health Protection Goals.)  CDC has also developed a critical resource that can be used to identify research priorities and support CDC’s Health Protection Goals.  This resource, Advancing the Nation’s Health:  A Guide to Public Health Research Needs, 2006-2015, contains 138 Research Themes spanning many areas of public health, and was developed with extensive input from its staff and a wide range of partners and stakeholders.  (See http://www.cdc.gov/od/science/PHResearch/cdcra/index.htm for an electronic copy of Advancing the Nation’s Health:  A Guide to Public Health Research Needs, 2006-2015).  Applicants are encouraged to use the Guide to Public Health Research Needs to help identify areas of research that support CDC’s Health Protection Goals.

Research Topics

Special importance is given to public health research issues critical to CDC priority populations, including: low-income and minority groups; women, children, the elderly,  and individuals with disabilities. Translation research needs to involve multi-disciplinary cooperation and collaboration which uses theories, empirical findings, and methods from a variety of fields not traditionally associated with public health research.   Relevant fields include information science; clinical and public health decision-making; organizational and management theory; finance; law; economics; business administration; statistics; communication; individual, group and systems-level behavioral change; anthropology; sociology; learning theory; community psychology; and marketing.

The following are examples of specific topics of interest to CDC. Note that the research topics provided below are examples only and applicants are not limited to addressing only these topics.

The Coordinating Office for Global Health (COGH) provides leadership within CDC and works with partners around the globe to “help CDC help the world." COGH works to ensure that the world knows CDC represents the best values of the United States, illustrated by our compassion, caring, and commitment. We will share our technical strengths and resources to improve global health. COGH works with CDC's global programs and partners to not only achieve today's global health priorities, but to create sound strategies to address tomorrow's challenges.

COGH is interested in research that develops and test models for translation that address its goals, http://www.cdc.gov/cogh/ , especially those that identify synergies between different injury or disease-specific interventions (such as those that address HIV/AIDS and also reproductive health or malaria), or that address critical health systems issues that are critical to public health advances.   While research applications addressing these topics may be proposed, special consideration will be given to funding those related to:

•           Conduct implementation or diffusion research using an evidence-based intervention in an international setting (i.e., less-developed or middle-income country.  Special attention should be paid to the effect of cost-effectiveness on the host country’s stakeholders and target population’s adoption of the intervention).

•           Identify innovative ways to increase the translation of proven interventions for Disease Control Priorities in Developing Countries (available at: http://www.dcp2.org/pubs/DCP).

•           Characterize best practices to improve translation of proven interventions that map to the appropriate global translation research themes listed in the CDC Research Guide (See: http://www.cdc.gov/od/science/PHResearch/cdcra/index.htm).

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 with a focus on these priorities in emergency preparedness and response:

•           Characterize the facilitators and impediments, and define strategies  for the successful implementation of evidence-based interventions, such as exercises or drills which assist planners in resource allocation for vulnerable communities during a national disaster (example source: Public Health Workbook to Define, Locate and Reach Special, Vulnerable, and At-Risk Populations in an Emergency; http://www.bt.cdc.gov/workbook).

•           Characterize the facilitators or impediments, and define strategies  for the successful institutionalization of proven interventions, such as exercises or drills used for preparing the public health workforce to accomplish preparedness and response requirements in varied settings and populations (example source: Evidence-Based Early Psychological Intervention for Victims or Survivors of Mass Violence; http://www.dhhs.gov/emergency/index.shtml).

The Coordinating Center for Environmental Health and Injury Prevention (CCEHIP).  CCEHIP is comprised of the National Center for Injury Prevention and Control (NCIPC), the National Center for Environmental Health and the Agency for Toxic Substance and Disease Registry.

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.

While research addressing all of these topics may be proposed, special consideration will be given to funding the priorities listed below. (Relevant references can be found at http://www.cdc.gov/ncipc/res-opps/translation.htm).   

•           Older Adult Falls: Conduct implementation or diffusion research on any proven effective interventions such as home visits, exercise programs, home fall-hazard assessment and modification, and multi-faceted approaches adding in medication reviews and vision and hearing checks.  Target populations for prevention are high-risk older adults in community dwellings or older adults in assisted living facilities. 

•           Adolescent Motor Vehicle Injuries:    Identify methods to translate proven transportation safety interventions that reduce crashes and injuries, such as graduated drivers licensing and parental monitoring. Implementation strategies are needed that accelerate adoption of evidence base interventions and their adaptation in diverse settings.

•           Child Maltreatment (CM): Identify factors that encourage the adoption and use of evidence-based primary prevention strategies in CM, such as parenting or home visitation programs. To accelerate the widespread use of effective programs, research may address: impediments and facilitators to program adoption and sustained use; levels of skill and training necessary to successfully implement a program; conditions that encourage program use “as prescribed” by developers versus adaptation to local conditions”.

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 Agency for Toxic Substances and Disease Registry (ATSDR), http://www.atsdr.cdc.gov/, uses the best science, takes responsive public health actions, and provides trusted health information to prevent harmful exposures to toxic substances and exposure-related disease.

While research applications addressing all aspects of environmental health may be proposed, NCEH/ATSDR special consideration will be given to funding the priorities listed below.  (Relevant references can be found at http://www.atsdr.cdc.gov/2p-extramural_research_funding.html)

•           Healthy Homes and Communities:  Identify the facilitators and impediments to implementing more widely evidence-based interventions 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., mixed land use, activity centers, pedestrian infrastructure, appropriate residential density, greenspace, mass transit).

•           Foodborne Illness: Conduct implementation or diffusion research on physical (temperature control, storage practices) and administrative (food inspections, manager food safety certification) interventions that reduce foodborne illness.  Focus research on restaurants, the food service industry, governmental agencies, and policy-makers.

•           Climate Change: Identify the facilitators and impediments to implementing more widely the proven existing mitigation and adaptation interventions in the public and private sectors.  Climate change may affect public health through propagation of infectious diseases, heat waves, severe weather events, and interruptions of the food supply, among other mechanisms. 

The Coordinating Center for Health Information and Service (CoCHS) assures that CDC provides high-quality information and programs in the most effective ways to help people, families, and communities protect their health and safety.  CoCHS and is comprised of The National Center for Health Statistics (NCHS), National Center for Health Marketing (NCHM), and National Center for Public Health Informatics (NCPHI).

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 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.

Areas of focus for this announcement include, but are not limited to: changing patterns of health care usage (e.g., home care and emergency room usage based on changes in insurance coverage; disease screening); prescribing practices of  evidence-based health recommendations and/or health policies (e.g., antibiotic or asthma prescribing practices following public health recommendations; changes in Medicare prescription drug benefit); proven interventions which reduce health disparities with emphasis on the reach to and adoption by population subgroups, such as racial and ethnic minorities and low income populations.

NCHS requests research using NCHS data sets, alone or in conjunction with other data sets to:

•     Examine the penetration of health recommendations and health policy into the general population, population subgroups and among health care providers. Identify characteristics of those groups that are not reached by the recommendations or those with widespread adoption of the recommendations. 

•     Examine and improve understanding of the processes by which evidence-based recommendations and policies become institutionalized and also characterize the impediments and facilitators to implementation or diffusion of these policies.

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.  While research applications addressing all of these topics may be proposed, special consideration will be given to funding translation research related to these three priorities:

•           A focus on applying accepted marketing principles and practices to improve the translation of research to practice in the context of enhancing the adoption of proven intervention approaches, such as those recommended by The Guide to Community Preventive Services.

•           Research on the utilization of effective partnerships to improve the dissemination of information and proven interventions to targeted high-risk populations.

•           A focus on developing innovative methods and models for the dissemination and implementation of interventions and information that largely incorporate electronic (e-health) platforms for use by diverse, high-risk populations.

The Coordinating Center for Health Promotion (CoCHP) works to enhance the potential for full, satisfying and productive living across the lifespan for all people in all communities.  CoCHP accomplishes this by promoting the improvement of public health through increased efficiencies, fostering strong collaborations, and integrating synergistic programs and messages.  CoCHP is comprised of the National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), the National Center on Birth Defects and Developmental Disabilities (NCBDDD), and the National Office of Public Health Genomics.

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 sex, age, race/ethnicity, geography, sexual orientation, socioeconomic status, disability, and special needs. 

NCCDPHP is interested in research that develops and test models for translation, dissemination, and institutionalization of effective programs/policies that utilize a community-partnered approach to promote health and prevent disease across all stages of life.  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:

•           Implementation:  Develop and evaluate strategies to translate and implement evidence-based interventions in populations and in settings where health disparities persist.  Sources for interventions having sound experimental design include, but are not limited to, The Guide to Community Preventive Services and the Prevention Research Centers.

•           Accessibility:  Determine the most efficient/effective ways to implement an evidence-based intervention to those at high-risk.  Identify characteristics of effective delivery systems and analyze factors that affect acceptability and adoption of the intervention.

•           Sustainability:  Increase the translation of evidence-based interventions into sustainable community change using partnerships and collaborations.  Analyze factors that contribute to sustainability in diverse, high-risk, and hard-to-reach populations, including facilitators and impediments.   

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. While research applications addressing all of these topics may be proposed, special consideration will be given to funding translation research related to the following priorities:

•           Characterize the facilitators and impediments, and define strategies  for the successful implementation of evidence-based interventions recommended by CDC for preconception health and health care, in an applied community or clinical setting, with particular emphasis on those recommendations with evidence-based interventions for improving outcomes (e.g., alcohol, folic acid, smoking, diabetes, and HIV/STD screening prior to pregnancy). For additional information see: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5506a1.htm.

•           Characterize the facilitators and impediments, and define strategies for the successful implementation of the American Academy of Pediatrics recommendation for universal developmental screening of infants, children, and adolescents as a routine part of pediatric practice through training, technical assistance and practice management.  See following URLs for additional information:  

http://aappolicy.aappublications.org/cgi/content/full/pediatrics;108/1/192
http://www.medicalhomeinfo.org/screening/DPIP.html
http://www.cdc.gov/ncbddd/child/documents/AAP%20Coding%20Fact%20Sheet%20for%20Primary%20Care.pdf
http://www.dbpeds.org/articles/detail.cfm?id=123

The National Office of Public Health Genomics (NOPHG), http://www.cdc.gov/genomics/, works to integrate genomics into public health research, programs, and policy.  Special consideration will be given to research proposals addressing the following priorities:

•           Family History:  Investigate how widespread adoption of validated tools for the collection and analysis of family history can be better used for risk assessment and subsequent preventive measures (e.g., healthcare provider education efforts, public awareness campaigns).  Family history is the most consistent known risk factor for common chronic diseases such as cancer and coronary heart disease.

•           Genetic Testing:  Evaluate the factors (e.g., cost-effectiveness, public health and industry marketing, endorsement by advocacy groups) associated with provider and patient utilization of new genetic tests entering clinical practice, or of genetic tests already in use. Rapid growth in the number of commercially available genetic tests for disease prevention, diagnosis, and treatment poses a challenge for their effective translation into clinical practice. 

•           Genetics for Early Disease Detection and Intervention:  Evaluate the adoption and use of validated interventions providing education about symptom recognition and family history, screening and genetic testing, and referral to appropriate services. Many persons with genetic diseases such as hereditary hemochromatosis or familial hypercholesterolemia are either missed by the healthcare system or not diagnosed early enough for effective and appropriate intervention. 

The mission of the Coordinating Center for Infectious Diseases (CoCID) is to protect health and enhance the potential for full, satisfying and productive living across the lifespan of all people in all communities related to infectious diseases.  CoCID is comprised of the following proposed National Centers:  National Center for Immunization and Respiratory Diseases (NCIRD); the National Center for Zoonotic, Vector-Borne and Enteric Disease (NCZVED); the National Center for HIV, Viral Hepatitis, STDs and Tuberculosis Prevention (NCHHSTP); and the National Center for Preparedness, Detection and Control of Infectious Diseases (NCPDCID).

The mission of the National Center for Immunization and Respiratory Diseases (NCIRD) is to maximize the prevention of disease, disability, and death through immunization and by control of respiratory and related diseases.  While research applications addressing all of these topics may be proposed, special consideration will be given to funding translation research related to the following priorities:

•           Adolescent immunization:  Several vaccines have recently been recommended for routine use in adolescents. Implementation of programs to reach adolescents is challenging because of relatively limited preventive health care encounters in this age group, and a number of other preventive services recommended for this age group.  Characterize the facilitators and impediments and identify effective strategies for the achievement of high vaccination coverage in the context of integrated adolescence preventive services to inform future best practices.

•           Immunization information systems (IIS):  Immunization information systems potentially harness information technology to improve service delivery, quality assurance, and monitor performance in achieving high immunization coverage. Characterize the facilitators and impediments and identify effective strategies for increased provider participation in IIS and the maintenance of comprehensive records in order to expand vaccination coverage across all age groups. 

•           Characterize the factors that promote successful adoption of global polio eradication initiatives (e.g., cost-effectiveness, training needs, and infrastructure).

The mission of the National Center for Zoonotic, Vector-Borne and Enteric Disease (NCZVED) maximizes public health and safety nationally and internationally through the elimination, prevention, and control of disease, disability, and death caused by suspected and confirmed zoonotic, vector-borne, foodborne, waterborne, mycotic, prion and related infections. While research applications addressing all of these topics may be proposed, special consideration will be given to funding translation research related to these three priorities:

•           Characterize the factors necessary to achieve greater implementation of evidence-based interventions to control the neglected tropical diseases such as lymphatic filariasis, onchocerciasis, schistosomiasis, trachoma and intestinal helminthes.  The proposal should include how these interventions can be incorporated as part of routine public health prevention activities, leading to sustainable reductions in morbidity and disease transmission.

•           Characterize the factors necessary to effectively implement evidence based education and prevention interventions to minimize bacterial illness associated with infant formula use (e.g., health care provider training in powdered and liquid formula use, preparation and patient counseling).

•           Characterize variables to increase adoption of hand washing or use of waterless hand gels among young children, their families, and their communities.

The mission of the National Center for HIV, Viral Hepatitis, STDs and Tuberculosis Prevention (NCHHSTP) is to maximize public health and safety nationally and internationally through the elimination, prevention, and control of disease, disability, and death caused by Human Immunodeficiency Virus Infection/Acquired Immunodeficiency Syndrome, Non-HIV Retroviruses, Viral Hepatitis, other Sexually Transmitted Diseases (STD), Tuberculosis, and Non-Tuberculosis Mycobacteria.  While research applications addressing all of these topics may be proposed, special consideration will be given to funding translation research related to these three priorities:

•           Characterize facilitators or impediments, and define strategies for the successful implementation for a proven intervention to reduce reproductive sequelae of STD for Chlamydia by enhancing screening, treatment, and partner services.

•           Characterize the factors necessary for the increased implementation of recommended prevention services of pregnant women infected with Hepatitis B, their exposed newborns, and other family contacts.

•           Characterize the factors that can increase providers’ implementation of evidence-based therapies for latent tuberculosis infection for persons infected with tuberculosis and at a high risk of progressing to tuberculosis disease (e.g., contacts of infectious tuberculosis patients, HIV-infected persons).

The mission of the National Center for Preparedness, Detection and Control of Infectious Diseases (NCPDCID) is to maximize prevention, preparedness and response to infectious diseases in order to protect populations domestically and internationally through leadership, partnerships, epidemiologic and laboratory studies, and the use of quality systems, standards, and practices.  While research applications addressing all of these topics may be proposed, special consideration will be given to funding translation research related to these three priorities:

•           Characterize facilitators and impediments and define strategies for the successful implementation of evidence-based recommendations for reducing transmission and subsequent infection with multi-drug resistant organisms (e.g., methicillin-resistant S. aureus, Clostridium difficile) in both healthcare and other public health settings.  Effective prevention measures have been identified through quasi-experimental design studies, prospective trails, and outbreak control, but successful implementation strategies are unclear. 

•           Characterize facilitators and impediments and define strategies for the successful translation of vaccination recommendations and other evidence-based interventions to prevent infectious diseases among international travelers.

•           Identify what travel health practitioners consider the facilitators and impediments, and define strategies for the successful implementation of pre- and post- travel evidence-based recommendations for the reduction of infectious diseases among travelers. 

The National Institute for Occupational Safety and Health (NIOSH) is the federal agency responsible for conducting research and making recommendations for the prevention of work-related illnesses, injuries, and fatalities (http://www.cdc.gov/niosh/homepage.html). One of the cornerstones of NIOSH’s efforts is a Research to Practice (r2p) program that focuses on the transfer of research findings, technologies, and risk-reduction methods into effective prevention practices, interventions, and products that will be used in the workplace (http://www.cdc.gov/niosh/r2p/). 

For this announcement, 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.  Investigations should include factors that influence managers, workers, contractors, building owners, and others in adopting proven interventions.  Results of the investigations should document improvements in workplace health and safety.  While research applications may address any aspect of the prevention of work-related illnesses, injuries and fatalities, special consideration will be given to the following areas:

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.  Special consideration will be given to the following research priority:

The mission of the Office of the Chief of Public Health Practice (OCPHP), www.cdc.gov/od/ocphp, is to advance achievement of CDC's Health Protection Goals through science-based, practice-oriented standards, policies and law.  OCPHP serves as the advocate, guardian, promoter, and conscience of public health practice throughout CDC/ATSDR and in the larger public health community and ensures coordination and synergy of CDC/ATSDR’s scientific and practice activities. Activities in support of the mission are carried out through programs and offices focused on public health law, public health system standards, public health agency accreditation, and surveillance for emerging issues in public health practice. Special consideration will be given the following research priority:

References

1.      Briss PA, Brownson RC, Fielding JE, Zaza S. Developing and using the Guide to Community Preventive Services: lessons learned about evidence-based public health.  Annu. Rev. Public Health 2004; 25:281-302.

2.      Briss PA. Evidence-based: US road and public-health side of the street (letter).   Lancet 2005; 365: 828-830.

3.      Davis D, Evans M, Jada A, et al.  The case for knowledge translation: shortening the journey from evidence to effect.  BMJ 2003;327:33-35.  Available at URL: http://www.bmj.com/cgi/content/full/327/7405/33.

4.      Glasgow R, Lichtenstein E, Marcus AC.  Why don’t we see more translation of health promotion research to practice? Rethinking the efficacy-to-effectiveness transition.  AM J Public Health 2003;93:1261-1267.

5.      GRADE working group.  Grading quality of evidence and strength of recommendations BMJ 2004;328:1490.

6.      Johnson, J. L., Green, L. W., Frankish, C. J., MacLean, D. R. and Stachenko, S. A dissemination research agenda to strengthen health promotion and disease prevention. Canadian Journal of Public Health, 1996; 87: S5–S10.

7.      Implementation Research: A synthesis of the literature.  Available at URL: http://nirn.fmhi.usf.edu/resources/publications/Monograph/.

8.      Institute of Medicine. Crossing the Quality Chasm: a new health system for the 21st century 2001.  Brief report is available from: URL: http://www.iom.edu/CMS/8089/5432/27184.aspx.

9.      Lefant C. Shattuck lecture: Clinical research to clinical practice—lost in translation? N Engl J Med 2003; 349: 868-874.

10.  Maidbach E, Van Duyn MAS, Bloodgood B. A marketing perspective on disseminating evidence-based approaches to disease prevention and health promotion.  Prev Chronic Dis [serial online] 2006 Jul [December 12, 2006].  Available from: URL: http://www.cdc.gov/pcd/issues/2006/jul/05_0154.htm.

11.  Mowbray CT, Holter MC, Teague GB, Bybee D. Fidelity criteria: development, measurement, and validation. Am J Eval; 24:315-340.  Available from: URL:  http://aje.sagepub.com/cgi/content/abstract/24/3/315.

12.  Oldenburg BF, Sallis JF,French ML,Owen N. Health promotion research and the diffusion and institutionalization of interventions. Health Education Research. 1999; 14: 121-130.

13.  Rohrbach LA, Grana R, Sussman S, Valente TW. Type II Translation: transporting prevention interventions from research to real-world settings.  Eval Health Prof 2006; 29: 302-333.

14.  Rychetnik L, Frommer M, Hawe P, Shiell A.  Criteria for evaluating evidence on public health interventions.  J Epidemiol Community Health 2002;56:119-127.

15.  Taskforce on Community Preventive Services.  Guide to Community Preventive Services 2004.  Available at URL:  http://www.thecommunityguide.org/           .

16.  Sussman S, Valente TW, Rohrbach LA, Skara S, Pentz MA. Translation in the health professions: converting science into action. Eval Health Prof. 2006 Mar;29(1):7-32.

17.  US Preventive Taskforce. Available at URL: http://www.ahrq.gov/clinic/uspstfix.htm.

18.  Walker AE, Grimshaw J, Johnston M, Pitts N, Steen N, Eccles M. Prime-Process modeling in ImpleMEntation research: selecting a theoretical basis for interventions to change clinical practice.  BMC Health Serv Res 2003: 3:22.  Available from URL: http://www.biomedcentral.com/1472-6963/3/22.

Helpful Resources

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the R18 activity code.

2. Funds Available

The Office of Public Health Research intends to commit approximately $10 million in total cost dollars in FY2007 to fund approximately 28 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 funded amount is $1,050,000 to $1,350,000 including direct and indirect costs. The anticipated start date for new awards is September 2007.

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

Institutions eligible to receive CDC funding:  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: Foreign institutions are not eligible to apply.  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.  

Institutions eligible to receive ATSDR funding:  You may submit an application(s) if your organization has any of the following characteristics, states, or state organizations and political subdivisions thereof, or their bona fide agents such as:

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.

1.B. Eligible Investigators

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support.

2. Cost Sharing or Matching

This program does not require cost sharing or matching.

The most current HHS Grants Policy Statement is available at:  http://www.cdc.gov/od/pgo/funding/HHS_GPS_Oct_2006.doc.

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:  PGOTIM@cdc.gov.

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

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates
Letter of Intent Receipt Date: March 12, 2007
Application Submission Receipt Date(s): April 10, 2007
Peer Review Date(s):  June 2007
Council Review Date(s): June/July 2007
Earliest Anticipated Start Date(s): September 2007

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:

Scientific Review Service
Office of Public Health Research
CDC Office of the Chief Science Officer
1600 Clifton Rd., MS D-72
Atlanta, GA 30333
Telephone: (404) 639-4621
Fax: 404-639-4903
Email: ophrinfo@cdc.gov

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 may be delayed in the review process or not 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.

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 not apply to this program.

5. Funding Restrictions

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the Grants Policy Statement at:

6. Other Submission Requirements

All applicants must address the following other submission requirements in their applications.  Specifically, applicants must address the following in their Research Plan:

Characteristics of the proposed intervention

Applicants must substantiate and cite appropriate references for the efficacy or effectiveness of the proposed study intervention and provide a justification of the intervention’s relevance to the target population. For the purposes of this RFA an intervention is defined as 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 can be a medical or behavioral therapy, modification to the natural or built environment, including engineering controls, public heath policy, public health program, health communication, or public health law. 

The proposed interventions must be evidence-based, can be singular or systems-based; clinical or public-health focused; and directed to an individual, racial/ethnic groups, or a community.  The concept of what is meant by “evidence-based” is challenging as it connotes many different meanings. One generic definition of “evidence” is the provision of proof in support of conclusions.  Although many entities have attempted to describe a systematic categorization for quality of evidence, no uniform definition or assessment exists that can be used appropriately for all public health situations (Rychetnik 2002, Grading quality of evidence and strength of recommendations BMJ 2004, U.S. Preventive Services Task Force).  Therefore for the purpose of this RFA, evidence-based means that the proposed 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).  For the purposes of this RFA the following terms are interchangeable, “evidence-based”, “proven”, “effective”, “valid” or “sufficient scientific evaluation”. Therefore, it is the responsibility of the investigative team to demonstrate that sufficient evidence exists when proposing the conduct of dissemination research, implementation research or diffusion research of a specific intervention.   

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.  Professional or national organizations also publish consensus documents that indicate or infer there is evidence of efficacy or effectiveness for the intervention but do not provide the data (e.g., select guideline recommendations).  Varying interpretations of “sufficient scientific evaluation” do exist.  To guide applicants, an example list of possible sources that describe evidence-based interventions follows:  (This list is not exhaustive and serves only as an illustrative example).

Evaluation Plan

The evaluation plan must annotate a robust methodology to assess system fidelity, adaptation of the intervention, health outcome or impact in the target population, scalability and their interaction.   Although the evaluation plan should primarily focus on the key variables for translation research (e.g., reach, adaptation, adoption) the evaluation plan must also include relevant and comprehensive criteria to accurately measure and document the desired health outcome (e.g., changes in exposures, behavior, and the incidence of illness, injury, morbidity or fatality). In particular, the assessment of generalizability should be included (e.g., external validity). Novel evaluation models are acceptable with justification or applicants may elect to use previously published models such as:

Key translation research questions to consider in the evaluation plan:

Classic health quantitative measures or patient outcome/impact results can be measured using tradition evaluation models.  Some examples follow:

Community Action Plan (CAP)

If applicable, applicants must articulate 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).

Specifically, applicants should outline and justify the dissemination, implementation, or diffusion drivers.  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).  

Applicants’ research plan(s) should address activities they will conduct over the entire project period.

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.

The following materials may be included in the Appendix:

Up to five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

Do not to use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements. 

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://www.cdc.gov/od/pgo/funding/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 by the Office of Public Health Research in accordance with the review criteria stated below.

The peer review of all applications consists of the following:

Applications submitted in response to this FOA will compete for available funds with all other eligible applications. The criteria listed 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? How can 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 proposed intervention is evidence-based?   

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 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.  These costs may be reimbursed only to the extent considered allowable pre-award costs.  See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about  requirements.  For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. Additional requirements are available 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 RFA, please contact Christine Casey, M.D. (OPHR).  For specific scientific questions concerning the research topics listed in this RFA, please contact the individual identified below for the corresponding CDC organizational unit.  Please note that Juliana K. Cyril, Ph.D., M.P.H.

will serve as the point-of-contact for the CDC organizational units which do not list a specific scientific contact individual (e.g., COGH, COTPER, NOPHG, NCHM, OMHD and OCPHP).

Juliana K. Cyril, Ph.D., M.P.H.
(Serves as contact for: COGH, COTPER, NOPHG, NCHM, OMHD and OCPHP) Associate Director for Policy and Peer Review
Office of Public Health Research
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS D-72
Atlanta, GA 30333
Telephone: 404-639-4639
Fax: 404-639-4903
Email: jcyril@cdc.gov

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: rwaxweiler@cdc.gov

Mildred Williams-Johnson, Ph.D., D.A.B.T.
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 E-28
Atlanta, GA 30333
Telephone:  404-498-0639
Fax: 404.498.0059
Email:  mwillians-johnson@cdc.gov

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: vcain@cdc.gov

Brenda Colley-Gilbert, Ph.D. MSPH
Director (acting), Extramural Research
National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)
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: bcolleygilbert@cdc.gov

Don Lollar, Ed.D.
Director (acting)
Office of Extramural Research
National Center on Birth Defects and Developmental Disabilities (NCBDDD)
Centers for Disease Control and Prevention
1600 Clifton Road NE, MS E-88
Atlanta, GA 30333
Telephone:  404-498-3041
Fax: 404-498-3050
Email: dlollar@cdc.gov

Brian W.J. Mahy, M.A. Ph.D. Sc.D. D.Sc.
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:  bmahy@cdc.gov

Wilbert J. Newhall, Ph.D.
Assistant Director for Program and Development
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: jnewhall@cdc.gov

2. Peer Review Contact:

Christine Morrison, 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) 639-3098
Fax: 404-639-4903
Email: CJM3@cdc.gov

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: 770-488-2670
Email: MIJ3@cdc.gov

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: PGOTIM@cdc.gov

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection
Federal regulations (45 CFR Part 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).   Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

Use of Animals in Research
Recipients of PHS support for activities involving live, vertebrate animals must comply with the PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.  Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements can be found at http://www.cdc.gov/od/pgo/funding/ARs.htm

Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research
It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

INCLUSION OF PERSONS UNDER THE AGE OF 21 IN RESEARCH
The policy of CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including persons under the age of 21. If persons under the age of 21 will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.

In 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.


HIV Program Review Panel Requirements

Compliance with Content of AIDS-Related Written Materials, Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions (June 1992) is required.

To meet the requirements for a program review panel, you are encouraged to use an existing program review panel, such as the one created by the State health department's HIV/AIDS prevention program. If you form your own program review panel, at least one member must be an employee (or a designated representative) of a State or local health department. List the names of the review panel members on the Assurance of Compliance form, CDC 0.1113. Submit the program review panel's report that all materials have been approved.

If the proposed project involves hosting a conference, submit the program review panel's report stating that all materials, including the proposed conference agenda, have been approved. Submit a copy of the proposed agenda with the application.

Before funds are used to develop educational materials, determine whether suitable materials already exist in the CDC National Prevention Information Network (NPIN).  The website can be found at; http://www.cdcnpin.org/scripts/index.asp.

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.

Executive Order 12372 Review

Applications are subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (E.O.) 12372. The order sets up a system for State and local governmental review of proposed Federal assistance applications. Applicants should contact their State single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State process. For proposed projects serving more than one State, the applicant is advised to contact the SPOC for each State affected.

Click on the following link to get the current SPOC list  http://www.whitehouse.gov/omb/grants/spoc.html.

Indian tribes must request tribal government review of their applications.

SPOCs or tribal governments that have recommendations about an application submitted to HHS/CDC should send them, in a document bearing the program announcement number, no more than 60 days after the application deadline date, to:

Mattie Jackson, Grants Management Specialist
Grants Management Specialist
Procurement and Grants Office
Announcement Number RFA-CD-07-005

Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, Georgia 30341-4146

HHS/CDC does not guarantee to accept or justify its non-acceptance of recommendations that are received more than 60 days after the application deadline.

Public Health System Reporting Requirements

This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:

A. A copy of the face page of the application (SF 424).

B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:

1.           A description of the population to be served.

2.           A summary of the services to be provided.

3.           A description of the coordination plans with the appropriate state and/or local health agencies.

If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.

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.

Peer and Technical Reviews of Final Reports of Health Studies – HHS/ATSDR

The Comprehensive Environmental Response, Compensation and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9604(i)(13)] requires that:

1. Studies must be reported or adopted only after appropriate peer review.

2. Studies shall be peer reviewed within a period of 60 days to the maximum extent practical.

3. Studies shall be reviewed by no fewer than three or more than seven reviewers who:

HHS/ATSDR encourages rapid reporting and interpretation of laboratory results and reference ranges back to individual participants. However, if summary tables or distribution of laboratory results are prepared using the study data, this is considered a preliminary finding and will require ATSDR technical and peer review prior to release.

When, in the opinion of the investigator(s), a public health concern exists requiring the release of summary study statistics prior to the completion of the study, the investigator must obtain concurrence from HHS/ATSDR prior to releasing the summary statistics. A request for HHS/ATSDR concurrence for the release of information must be documented in a letter to HHS/ATSDR and should outline the public health concern, the investigator's interpretation of the concern and recommended response, and the draft document proposed for release by the investigator. HHS/ATSDR will provide a technical review and peer review within ten working days to the maximum extent possible. At sites where HHS/ATSDR must coordinate with another Federal agency, this requires additional time. Summary statistics may be released only after peer review. The release of summary statistics does not preclude the requirement for a final report.

By statute, the reporting of preliminary studies and preliminary research results to the public is not acceptable without prior review by HHS/ATSDR. This includes manuscripts prepared for publication, presentations at scientific meetings and reporting of preliminary findings to the community or the media.

Final Report

1. The final report for every study should include a detailed description of the problem, hypothesis, methods, results, conclusions, and recommendations that constitute a complete performance record of the study. A copy of the suggested format for the final report will be supplied by HHS/ATSDR to the investigator.

2. HHS/ATSDR is responsible for the technical and peer review of the draft final reports of any study that it funds prior to the submission of the final report. This will allow the recipient to incorporate technical and peer review comments into the final report. Responses to all HHS/ATSDR required technical and peer review comments should be summarized in a letter to HHS/ATSDR. This letter should also include the investigator's response to each comment and a rationale for those responses. Based upon the comments of the technical and peer reviewers, modifications in the study report may result. The modified study report should accompany the letter to HHS/ATSDR.

3. Following the steps outlined above, a final report of all studies and results of research carried out or supported by HHS/ATSDR must be submitted to the Procurement and Grants Office with a copy furnished to HHS/ATSDR.

All requirements, including peer review, technical review, and cost recovery, are applicable to award recipients and any subcontractors employed by the award recipient. Failure to comply with these requirements could adversely affect future funding.

Cost Recovery – HHS/ATSDR

CERCLA, as amended by SARA, provides for the recovery of costs, from potentially responsible parties, of health assessments and health effects studies carried out under Section 104(i) of CERCLA, as well as for costs of removal and remedial actions incurred by the United States Government not inconsistent with the National Contingency Plan. The recipient would agree to maintain an accounting system that will keep an accurate, complete, and current accounting of all financial transactions on a site-specific basis, i.e., individual time, travel, and associated cost including indirect cost, as appropriate for the site. The recipient would also maintain documentation that describes the site-specific response actions taken with respect to the site, e.g., contracts, work assignments, progress reports, and other documents that describe the work performed at a site. The recipient will provide the site-specific costs and description of response actions taken with the supporting documentation upon request by HHS/ATSDR. The recipient will retain the documents and records to support these financial transactions and documentation of work performed, for possible use in a cost recovery case, for a minimum of ten years after submission of a final financial status report, unless there is litigation, claim, negotiation, audit or other action involving the specific site, then the records will be maintained until resolution of all issues on the specific site.

Third Party Agreements – HHS/ATSDR

Applicant must justify the need to use a contractor. If contractors are proposed, the following must be provided: (1) name of contractor, (2) method of selection, (3) period of performance, (4) detailed budget, (5) justification for use of contractor, and (6) assurance of non-conflict of interest.

Project activities which are approved for contracting pursuant to the prior approval provisions shall be formalized in a written agreement that clearly establishes the relationship between the recipient and the third party.

The written agreement shall, at a minimum:

1. State or incorporate by reference all applicable requirements imposed on the contractors under the terms of the grant and/or cooperative agreement, including requirements concerning technical review (ATSDR selected reviewers), ownership of data, and the arrangement for copyright when publications, data, or other copyrightable works are developed under or in the course of work under a PHS grant-supported project or activity.

2. State that any copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal government purposes.

3. State that whenever any work subject to this copyright policy may be developed in the course of a grant by a contractor under a grant, the written agreement (contract) must require the contractor to comply with these requirements and can in no way diminish the government's right in that work.

4. State the activities to be performed, the time schedule for those activities, the policies and procedures to be followed in carrying out the agreement, and the maximum amount of money for which the grantee may become liable to the third party under the agreement.

5. State non-conflict of interest concerning activities conducted for HHS/ATSDR and site-remediation activities for other parties.

The written agreement required shall not relieve the recipient of any part of its responsibility or accountability to PHS under the cooperative agreement. The agreement shall, therefore, retain sufficient rights and control to the recipient to enable it to fulfill this responsibility and accountability.

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/.

Health Insurance Portability and Accountability Act Requirements

Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions.  The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency.  HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

Release and Sharing of Data

The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the HHS/CDC data sharing agreement will be released as follows:

  1. In a timely manner.
  2. Completely, and as accurately as possible.
  3. To facilitate the broader community.
  4. 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. 

National Historic Preservation Act of 1966

(Public Law 89-665, 80 Stat. 915)

The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:

a.      Section 106 of the National Historic Preservation Act (NHPA) states:

The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking,  shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register.  The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.

b.      Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”

Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.

Conference Disclaimer and Use of Logos

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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