BUILDING THE EVIDENCE TO PROMOTE BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCY PREPAREDNESS IN HEALTH CARE SYSTEMS RELEASE DATE: May 30, 2003 PA NUMBER: PAR-03-130 (see Notice of Deactivation NOT-HS-04-008) CFDA NUMBER: 93.226 Agency for Healthcare Research and Quality, AHRQ (http://www.ahrq.gov) APPLICATION RECEIPT DATES: July 17, 2003, January 14, 2004, January 14, 2005, and January 17, 2006 This Program Announcement expires on August 27, 2004 per Notice of Deactivation NOT-HS-04-008. THIS PA CONTAINS THE FOLLOWING INFORMATION: o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations o References PURPOSE OF THE PA The Agency for Healthcare Research and Quality (AHRQ) announces the availability of 1-2 year (maximum 2 years) research grants that will examine and promote the health care system's readiness for a bioterrorist event and other public health emergencies through the development of new evidence, tools and models. In light of recent events in the U.S., there is considerable urgency to develop a public health infrastructure that is prepared to respond to acts of bioterrorism and other public health emergencies. AHRQ recognizes that community clinicians, hospitals, and health care systems have essential roles to play in this infrastructure. To inform and assist these groups in meeting the health care needs of the U.S. population in the face of bioterrorist threats and other public health emergencies, AHRQ intends to support research that emphasizes the following research objectives: (1) Emergency preparedness of hospitals and health care systems for bioterrorism and other public health emergencies; (2) Enhanced capacity needs of ambulatory care, home and long term care, care of psycho- social consequences, and other related services during and after a bioterrorist event and other public health emergencies; (3) Information technology linkages and emerging communication networks to improve the linkages between the personal health care system, emergency response networks and public health agencies; (4) Novel uses of health care system training strategies that can prepare community clinicians to recognize and manage a bioterrorist event and other public health emergencies. RESEARCH OBJECTIVES The mission of the Agency for Healthcare Research and Quality (AHRQ) is to support and conduct research that improves the outcomes, quality, access to, and cost and utilization of health care services. AHRQ achieves this mission through health services research designed to: (1) improve clinical practice, (2) improve the health care system's ability to provide access to and deliver high quality, high-value health care, (3) provide policymakers with the ability to assess the impact of payment and organizational changes on outcomes, quality, access, cost and use of health care services. In doing so, AHRQ seeks to identify and respond to the information needs of consumers, patients, clinicians, and other providers, institutions, plans, purchasers, and Federal and State policy-makers, and to provide them the information they need to make evidence-based decisions. AHRQ's investment in bioterrorism and other public health emergencies preparedness research recognizes that community clinicians, hospitals, and health care systems have essential roles in the public health infrastructure. These research investments are intended to complement the department's investments through the CDC and HRSA programs. The application of health services research and health system research to the area of bioterrorism and other public health emergency preparedness is a relatively new area of inquiry. AHRQ's particular interest in bioterrorism and other public health emergency preparedness research focuses on the role of the health care system in preparing for and responding to bioterrorism other public health emergencies. Specifically, these projects will highlight issues of health care system preparedness and coordination between public health and health care systems. This is an emerging field in need of researchers with health services research skills that can be applied to bioterrorism other public health emergency preparedness research. For example, while health services research has examined hospital capacity and throughput, there has been limited application of these techniques to surge capacity as it relates to bioterrorism and other public health emergency preparedness. Although the grants will focus broadly upon the emergency preparedness of health care systems, AHRQ encourages particular attention to the preparedness of these systems with regard to specific priority populations. These populations include children, residents of inner- city areas and rural areas (including frontier areas); low income groups; minority groups; women; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. For many of these groups, there is limited information about potential differences in the detection and treatment of bioterrorism-related illnesses. AHRQ also recognizes the difficulty in conducting research on actual bioterrorist events. As a result, many of the proposed projects will involve theoretical and systemic modeling. However, special emphasis should also be placed upon the real-world application of these models through exercises and demonstrations. These research grants will address pressing national concerns about the health care system's preparedness for bioterrorism and other public health emergencies. For that reason, 1-2 year grants will be supported with the expectation of rapid turnaround and the timely dissemination of results. Insert language from partnerships grants re: coop agreements and dissemination? Therefore, the total project period for an application submitted in response to this PA may not exceed two years. Grants funded in response to this program announcement will be funded in one year budget periods. Background The anthrax incidents of October 2001 and SARS 2003 quickly illuminated the challenges that faced our public health and hospital systems and highlighted the need for a rapid response in building up the public health infrastructure. Additionally, the need for comprehensive plans for hospital preparedness, better coordination of communication systems, and real time information networks between front line providers and local health departments were apparent and urgent. Recent studies have demonstrated that the preparedness and infrastructure of hospitals and the public health system are inadequate to deal with a bioterrorist attack (Inglesby, Khan, Garrett, Wetter). One study found that the majority of primary care providers do not feel prepared to diagnose and manage a bioterrorist event (Chen). As a result, there has been heightened awareness and responsiveness of many groups over the recent months. AHRQ has been working with the Department of Health and Human Services' Office of Public Health and Emergency Preparedness on activities that capitalize on the unique expertise and abilities of health services researchers to identify and evaluate strategies for enhancing the intersection of health care system needs and resources with public health infrastructure. AHRQ Evidence-Based Practice Center (EPC) researchers at Johns Hopkins University have reviewed and reported on the most effective means for training physicians for bioterrorism and other public health emergency preparedness. An Integrated Delivery System Research Network partner at Weill Medical Center designed a model for distributing medications in response to bioterrorist events that was put into place in New York City shortly after the anthrax incidents. AHRQ hopes to build upon the success of these projects by bringing health services research expertise to the problems of bioterrorism other public health emergency preparedness, and public health infrastructure. At the same time, emphasis is being placed upon 'dual use' technologies. 'Dual use' refers to systems of care, tools, or technologies that, while offering proven benefit in bioterrorism and other public health emergency preparedness, are also utilized in the everyday delivery of health care. Examples include the use of a pre- existing asthma surveillance system to help detect bioterrorist events, or the enhancement of current natural disaster warning systems to improve communication between clinicians and the public health system. Objectives and Scope of Activity: AHRQ seeks bioterrorism and other public health emergency preparedness projects that address these specific priority research areas: (1) Emergency preparedness of hospitals and health care systems for bioterrorism and other public health emergencies; (2) Enhanced capacity needs of ambulatory care, home and long term care, care of psycho- social consequences, and other related services during and after a bioterrorist event and other public health emergencies; (3) Information technology linkages and emerging communication networks to improve the linkages between the personal health care system, emergency response networks and public health agencies; (4) Novel uses of health care system training strategies that can prepare community clinicians to recognize and manage a bioterrorist event and other public health emergencies. (1) Emergency preparedness of hospitals and health care systems for bioterrorist events and other public health emergencies. The national health care system's ability to mobilize resources for surge capacity has become increasingly important since the anthrax cases in fall of 2001 and the recent advent of SARS. Readiness to respond to mass casualties expected from a large-scale bioterrorist attack and other public health emergencies is unique in its intersection of public health, clinical medicine and emergency management planning. It is critical that we examine the outcomes and cost of models of hospitals, hospital emergency departments, and health system readiness, including any proposed models of regional care. The lack of surge capacity in our current health care system is the primary issue for any locale dealing with casualties from a bioterrorist attack and other public health emergencies. In selected areas, the availability of nurses, pharmacists and other members of the health care team have been described in crisis, leaving some systems of care with little to no capacity to respond to bioterrorist events and other public health emergencies. Currently, little evidenced-based guidance has been available to assist metropolitan and non-metropolitan areas in planning for the provision of such expanded capacity. Given the current financial constraints confronting health care institutions and the current shortage of health care personnel, there is an enormous need for creative model development to address these looming problems. Surge capacity has three major aspects: facilities, equipment, and most importantly personnel. As issues of capacity are examined, there is a need to study the collaborative role of current systems not typically connected to networks of care such as the DoD and VA facilities and in some regions for-profit and not-for-profit institutions. Studies are needed to examine the impact of market forces on capacity and its effects on regional models of health care system preparedness. Staffing issues of surge capacity also need to be examined for various health care settings including hospital inpatient systems, emergency departments, primary care practices, alternative care sites, home care and long term care. In addition to the issues around surge capacity, adequate risk communication is vital for an effective response to bioterrorism and other public health emergencies. Risk communication is a science-based approach for communicating effectively in high-concern situations. There is a need for studies and models of good risk communication that are designed to meet the needs of diverse audiences in the event of a bioterrorist attack and other public health emergencies. For example, the health care workforce and first responders involved in a bioterrorist event and other public health emergencies need customized, well-organized information. Similarly, effective communication between designated spokespersons and the general public must be studied and implemented. Illustrative questions of interest under this priority area include: o What are the effects and costs of system readiness efforts on hospitals, hospital emergency departments and health systems? o Which indicators in regional care models are suggestive of preparedness? o How have regional care models improved public health preparedness and at what cost? o What staffing and personnel models can be employed to meet the requirements of surge capacity in the event of a bioterrorist event and other public health emergencies? o How can models of mass prophylaxis and vaccination be adapted for special populations such as children, elderly, and the homebound, homeless, disabled? o How does the health care system communicate risk to providers and the public? How can the effectiveness of that communication be measured? o What are the best means for risk communication? How will these models differ for the general public and health care provider communities? o How can current public health emergency communication systems be utilized for bioterrorism response? o What kind of intelligence would be most helpful pre , during and post event? and for what audience? o How would providers use that information?o What is the best vehicle for communication and with what groups are the various models most effective? (2) Enhanced capacity needs of a broad range of health care settings, including hospitals, emergency departments, ambulatory care, home and long term care, care of psycho-social consequences, and other related services during and after a bioterrorist event and other public health emergencies. Most preparedness activities to date have focused on the immediate needs for mass casualty events within emergency departments and hospitals. However, surge capacity issues impact all health care settings, including ambulatory care, home and long term care. In addition, many of the settings most in need of study are already affected by shortages and financial constraints. For example, ambulatory care settings may experience increased volume during the be involved initially in the mass casualty event, as well as a significant n increases in post event visits for both medical and psycho social evaluationssurge capacity. The problem of increased volume of individuals that must be accommodated when current capacity is exceeded at the emergent level is compounded by the post event care needs of those victims that will stress an overburdened segments of the system. Similarly, home care and long term care settings, which are already under strain, may be called upon to provide extended medical and psycho social care to persons affected by bioterrorism and other public health emergencies. Staffing issues and personnel demands, as well as cost implications, including reimbursement, need to be critically examined in variouswill be vital to these settings as enhanced capacity is requiredneeded. In the event of a bioterrorist attack and other public health emergencies, health care workers will be taxed to stretch their time and expertise and will most likely assume a heightened level of risk for themselves and their families. The psycho-social consequences of a bioterrorist event and other public health emergencies upon mental health care resources, health care utilization, and cost modeling, have not been studied. The redeployment of adequately trained mental health personnel in the case of a bioterrorist event or other public health emergencies will be vital, in addition to the role of cross trained personnel who are prepared to substitute and augment services for limited qualified mental health personnel. Examination and development of models for training, mobilization and management of individuals experiencing bioterrorism-related, or other public health emergencies will be critical. Illustrative questions of interest under this priority area include: o What is the role of various elements of the health care system in meeting the surge capacity demands in a regional model of care? o What are the barriers and demands for surge capacity on home care and long term care in a post event scenario of mass casualties? o What are the economic implications to rural health care systems in finances, personnel, and equipment in a bioterrorist event with mass casualties and other public health emergencies? o What models for cooperation are effective in regional models that may include school, hotels, and community health centers as alternate sites to care for victims of a bioterrorist event? o What is the capacity of existing special care systems to be enhanced and redesigned for use in the case of a bioterrorist event and other public health emergencies, such as poison control and, burn teams?, neonatal networks etc. o What models can be developed to deploy adequately trained mental health professionals to areas of need in the event of a bioterrorist or mass casualty event? o What are the financial and regulatory incentives for efficient models of regionalized health care services for care following a bioterrorist event and other public health emergencies? (3) Information technology linkages and emerging communication networks to improve the linkages between the personal health care system, emergency response networks and public health agencies. A key issue in the Nation's capacity to respond to the threat of bioterrorism and other public health emergencies will depend on the ability of clinicians, health care facilities, and public health officials to collect, analyze, manage, and communicate information rapidly, accurately, and effectively. Information and communication technologies (IT) can play a vital role in assisting clinicians and public health officials to detect and respond effectively to bioterrorism threats and other public health emergencies. These investments in IT are ultimately intended to assure a vital public health information network or to assure that such a network includes effective linkages with clinicians and health care settings. Unfortunately, the lack of a national interconnected health information infrastructure presents a significant barrier to realizing many of the potential benefits offered by IT. There are a number of IT systems currently in use in the clinical and public health sector in the United States. However, the majority of them were not designed for detecting or managing bioterrorism events or other emerging public health emergencies. In the recent study by the University of California San Francisco-Stanford Evidence-Based Practice Center (EPC), the investigators identified 217 IT systems of potential use by clinicians and public health officials in the event of a bioterrorist attack. They included 90 surveillance systems, 55 detection systems, 26 communication systems, 23 diagnostic systems, 18 management systems, and 7 systems that integrate surveillance, communication, and command and control functions. The investigators found that most of these systems were not designed specifically for bioterrorism, but instead were created for detecting and managing naturally occurring illnesses such as influenza. In addition, many of the systems had not been evaluated rigorously for their effectiveness in dealing with bioterrorism. In fact, many had not even been evaluated for their originally intended purpose. Most of the evaluations that did exist were limited in scope - they looked at the usefulness of the systems for their intended purpose, but they did not provide information about their effects on important outcomes. Despite these limitations, many of the systems were thought to be potentially useful for responding to bioterrorism threats, especially if they provided "dual use" functionality - i.e. they were designed to serve clinical or public health purposes, but they could also be adapted to respond to bioterrorism threats. IT can play a central role in the development of communication systems for providing bidirectional information flow in real-time between front-line clinicians and local, state, regional and national public health departments. The ability to collect, analyze and communicate this information is crucial for early detection of possible bioterrorist threats and other public health emergencies and can help facilitate the rapid mobilization of appropriate personnel and resources in response to such a bioterrorist event and other public health emergencies. The use of clinical decision support systems can also help clinicians, public health officials, and the public respond to perceived or actual threats by improving their knowledge, decision- making, and management abilities. Although IT offers immense potential as a key component of the Nation's armamentarium for dealing with the threat of bioterrorism and other public health emergencies, large gaps exist in current technologies and the application of these technologies to maximize the benefits of IT to improve public health preparedness. As demonstrated by the EPC report, further research is needed to learn the most effective and efficient ways to use IT to improve our Nation's capacity to respond to the threat of bioterrorism. IT applications that are designed to assist in the detection, diagnosis, reporting, treatment, communication, and overall management of potential and real bioterrorism events and other public health emergencies must be developed and evaluated with respect to their impact on important outcomes. Areas for further research include: evaluation of current systems to determine the best ways to leverage existing technology for bioterrorism and other public health emergency preparedness; development and evaluation of systems to improve surveillance and detection of possible threats; development and evaluation of diagnostic and treatment decision support systems to assist front-line clinicians, health care facilities, and public health officials, including innovative ways to provide fast and dependable communication links between local, state, regional, and national entities; use of automated systems that can gather important information from existing information sources; use of handheld devices to assist clinicians and public health officials respond to bioterrorism and other public health emergences; and the use of smart IT systems with analytical capabilities that are integrated into the clinical workflow and do not require redundant data input. Illustrative questions of interest under this priority area include: o How can existing IT systems such as hospital bed and emergency department monitoring systems be enhanced to and identify surge capacity and regional assets in the event of a bioterrorist attack and other public health emergencies? o What are the most effective models of communication networks that enhance the health care teams ability to be involved in early recognition, diagnosis and treatment of victims of a bioterrorist event and other public health emergencies. o What models can be designed that are effective at linking providers across the healthcare system with public health and the private health care system? 4) Novel uses of health care system training strategies that can prepare community clinicians to recognize and manage a bioterrorist event and other public health emergencies. Healthcare providers primary care clinicians in the community are a vital part of the health care system's response to bioterrorism and other public health emergencies. In particular, primary care and other community clinicians are important elements in the front-line response to those types of events. While there are data that suggest that primary care providers do not feel adequately prepared to deal with bioterrorist events, there is little information about effective training strategies that can prepare clinicians for such events. There is also limited information about other training issues relate to effective models of cross training of specialty physicians and specialty trained nurses for care of mass casualties in a bioterrorist event and other public health emergencies. There is a need for research on effective models of training and data systems to track the trained workforce are needed. In addition, further research is needed on how to and address issues of mobilizeing this healthcare workforce in the event of an attack. AHRQ is not seeking specific educational curricula but rather novel models and demonstrated strategies for training that can be implemented by health care systems. Illustrative questions of interest under this priority area include: o What training models are most effective in preparing healthcare personnel to care for rare public health events and bioterrorist agents? o What models of workforce tracking and mobilizations can be employed within a region or state level? o What are the lessons learned from disaster drills, table top exercises, formal classes, simulated events, that inform our effective planning for essential health care personnel and first responders? Are these exercises cost-effective? o Are computer simulations a cost-effective method for bioterrorism and other public health preparedness? o What information technologies and decision support tools are effective in training and enhancing the knowledge and skills of health care providers and first responders? MECHANISM OF SUPPORT This PA will use the cooperative agreement (U01) award mechanism, with this assistance mechanism, substantial AHRQ programmatic involvement with the awardees is anticipated during performance of the activity. The dominant role and prime responsibility for the activity resides with awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the AHRQ Program Official(s). Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section describing awardee and AHRQ rights and responsibilities. The anticipated award date is September 2003. AHRQ does not use the Modular Grant Application and Award Process. ELIGIBLE INSTITUTIONS You may submit (an) application (s) if your institution has any of the following characteristics: o For Profit or Non-profit organizations o Domestic and foreign o Public and private non-profit institutions, such as universities, clinics, colleges, hospitals, and professional associations o Units of State and local governments o Faith-based and community-based organizations o Tribes and Tribal Organizations Practice-based networks, such as Integrated Delivery System Research Networks or PBRN, are encouraged to apply. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible. Important Note: Under recent enacted reauthorization legislation, AHRQ is authorized to enter into cooperative agreements with for-profit organizations as well as with public and not- for profit entities. Thus, for-profit organizations are eligible to respond to this notice with applications for cooperative agreements. Such applications will be administered in accordance with Subpart E of 45 CFR Part 74 and 42 CFR part 67 Subpart A. This latter regulation has not yet been amended to reflect these changes in Agency name and authority. (See December 6, 1999, AHRQ reauthorization at http://www.ahrq.gov. Applicants are required to seek approval from AHRQ staff at least 3 weeks prior to the anticipated submission of any application requesting $500,000 or more in direct costs for any year. If staff is contacted less than 3 weeks before submission, there may be insufficient time to make a determination about assignment prior to the intended submission date. Applicants proposing grants for $500,000 or more for any year should read the "Advanced Approval of Unsolicited Applications That Request More Than $500,000 Direct Costs in Any One Year," published in the NIH Guide for Grants and Contracts on August 22,1997 http://www.ahrq.gov (under Funding Opportunities). INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution or organization to develop an application for support. Individuals from under represented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ programs. SPECIAL REQUIREMENTS Studies under this PA are expected to produce evidence, tools, and models that can be integrated into preparedness initiatives at the national, state, and local level. Applicants should be concrete in describing 1) decision making audiences most interested in the proposed research and 2) how applicants anticipate their results being used and by what audiences. The Agency recognizes that rural communities, which historically have had limited public health infrastructure, small numbers of providers and volunteer emergency medical services ( EMS), are considered most vulnerable and least able to respond. The ability of local first responders, public health agencies and providers to respond to an event is critical. Therefore, AHRQ recognizes the unique burden preparedness activities and expectations place on rural communities and will strongly encourage researchers to address rural considerations in all proposal as appropriate. Dissemination and implementation strategies should not be limited to publication in peer- reviewed journals, but should address mechanisms and vehicles to disseminate, implement, and communicate evidence, tools and models with appropriate national, state, and local entities, professional associations and other parties engaged in bioterrorism preparedness activities. TERMS AND CONDITIONS OF AWARD These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92, 42 CFR Part 67 Subpart A, and other HHS, PHS grants administration policy statements. Applicants should be familiar with the Agency's grant regulations, 42 CFR Part 67 Subpart A, and particularly sections 67.18-67.22. [Part 92 applies when State and local governments are eligible to apply as a "domestic organization."] Consistent with the U01 concept defined under Mechanism of Support, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the AHRQ Program Official(s). Awardee Rights and Responsibilities Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and AHRQ policies. AHRQ Staff Responsibilities The AHRQ Program Official(s) will have substantial scientific programmatic involvement in directing the grant activities to address priority issues of AHRQ and the U.S. Department of Health and Human Services regarding bioterrorism and other public health emergency preparedness initiatives. AHRQ staff will coordinate grantee activities with the Health Resources Services Administration Hospital Preparedness Program staff and other relevant DHHS agencies and provide technical assistance to the grantees on identifying key mechanisms, vehicles, and partners to disseminate, implement, and communicate the evidence, tools and models from these projects. The dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the AHRQ Program Official(s). AHRQ program official(s) will also facilitate the acquisition of appropriate data sets as needed. AHRQ reserves the right to terminate or curtail the study (or an individual award) in the event of any major delays or failure to adhere to the overall study design that may result in the failure to successfully produce the models, tools, or reports intended, or any human subject ethical issues that may dictate a premature termination. Collaborative Responsibilities When appropriate, AHRQ expects award recipients to work with each other to identify collaborative activities that contribute toward enhanced preparedness initiatives. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and AHRQ may be brought to arbitration. An arbitration panel will be composed of three members one selected by the individual awardee in the event of an individual disagreement, a second member selected by AHRQ, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. o Priority Populations The Agency's authorizing legislation (refer to http://www.ahrq.gov (Under Funding Opportunties) directs special attention in Agency programs to populations of inner-city areas and rural areas (including frontier areas); low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. Applications under this RFA should address attention to and potential benefits for these priority populations. o Publication Transmittal: General AHRQ Requirements In keeping with the Agency's efforts to translate the results of AHRQ- funded research into practice and policy, grantees and/or contractors are to inform the Office of Health Care Information (OHCI) when articles from their studies are accepted for publication in the professional literature. Grantees and contractors should also discuss any ideas about other dissemination and marketing efforts with OHCI staff. The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers. This is critical when outreach to the general and trade press is involved. Contact with the media will take place in close coordination with OHCI and the press offices of the grantee's or contractor's institutions. In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees and contractors will be asked to submit to OHCI a brief plan describing how the product will be publicized. An OHCI staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations to: Sally Phillips, RN, PhD Center for Primary Care Research Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: 301-427-1571 FAX: 301-427-1595 Email: sphillip@ahrq.gov o Direct your questions about peer review issues to: Carl Ohata, PhD Office of Research Review, Education, and Policy Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1549 FAX: (301) 427-1561 Email: cohata@AHRQ.gov Direct your questions about financial or grant management matters to: George Gardner Grants Management Specialist Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: (301) 427-1453 FAX: (301) 427-1464 Email: ggardner@ahrq.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and form (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone 301-710-0267, Email: GrantsInfo@nih.gov. The PA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the following application deadlines: July 17, 2003, January 14, 2004, January 14, 2005, and January 17, 2006. This Program Announcement expires on July 17, 2007 unless reissued. SUPPLEMENTAL INSTRUCTIONS: Applicants are encouraged to make use of AHRQ'S Healthcare Cost and Utilization Program (HCUP). The HCUP includes databases covering 1988- 1997, with 1998 and 1999 data available in 2001. These all-payer databases were created through a Federal-State-industry partnership to build a multistate healthcare data system. The main HCUP databases contain discharge-level information for inpatient hospital stays in a uniform format with privacy protections. The Nationwide Inpatient Sample (NIS) is a nationwide probability sample of about 1000 hospitals. The State Inpatient Databases (SID) contain inpatient records for all community hospitals in 22 states. Other HCUP databases contain ambulatory surgery data from nine states. These databases can be directly linked to county-level data form the Health Resources and Services Administration's Area Resource File and to hospital-level data from the Annual Survey of the American Hospital Association. This does not preclude the use of secondary data sources or primary data collection. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications according to instructions provided in form PHS 398 . Applications submitted in the Modular format will be returned without review. SENDING AN APPLICATION TO THE NIH and AHRQ: Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 (20817 for express/courier service) At the time of submission, two additional copies of the application, labeled "Advanced Copy (s)" must also be sent to: Sally Phillips, RN, PhD Center for Primary Care Research Agency for Healthcare Research and Quality 540 Gaither Road Rockville, MD 20850 Telephone: 301-427-1571 FAX: 301-427-1595 Email: sphillip@ahrq.gov SPECIAL APPLICATION REQUIREMENTS: Application Preparations: 1) Biographical Sketches: In addition to general biographical information, applicants should describe the relevant experience and activity of the researchers to this specific research area of study. 2) Research Plan: In addition to the overall elements of the research plan, applicants should address: o how the researcher/s have direct experience in the field of study described in this project or how their previous experience will transfer to this new area of research? o the decision making audiences most interested in the proposed research. o how applicants anticipate their results being used and by what audience? o a detailed plan for the mechanisms and vehicles to disseminate, implement, and communicate evidence, models, and tools with appropriate national, State, and local entities, professional associations, and other parties engaged in bioterrorism and other public health preparedness activities. APPLICATION PROCESSING: Applications must be received by the receipt dates listed in the heading of this PA. If an application is received after that date, it will be returned to the applicant without review. The CSR and AHRQ will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR and AHRQ will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. Although there is no immediate acknowledgment of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. Applicants are encourage to read all PHS Forms 398 instructions prior to preparing an application in response to this PA. The PHS 398 type size requirements (p.6) will be enforced rigorously and non-compliant applications will be returned. It is very important to note that limitations on number of pages and size of font must be observed; applications violating these requirements will be returned without review. Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an AHRQ application. The "AHRQ Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications" was published in the NIH Guide on September 27, 2000. (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html) The PA is also available on AHRQ's Web site, http://www.AHRQ.gov, (see under Funding Opportunities) and through AHRQ InstantFAX at (301) 594- 2800. To use InstantFAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the table of contents, which has the document order number (not the same as the PA number). The PA will be sent at the end of the ordering process. AHRQ InstantFAX operates 24 hours a day, 7 days a week. For comments or problems concerning AHRQ InstantFax, please call (301) 594-6344. TECHNICAL ASSISTANCE: AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. This conference call will be held on July 2, 2003, 1-3 p.m. Please contact Kelly Morgan kmorgan@ahrq.gov or 301-427-1570, 2 working days prior to the conference call. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. Purchase of CMS public-use data, if required, should be discussed in the application narrative and included in the budget. Application Preparation (for Using CMS Data) For applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the "Research Design and Methods" section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research. In consultation with Center for Medicare and Medicaid Services (CMS), previously called Health Care Financing Administration (HCFA), AHRQ will use this information to develop a cost estimate for obtaining the data. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made. Applicants should be aware that for individually identifiable Medicare and Medicaid data, Principal Investigators and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with AHRQ's confidentiality statue, 42 USC 299c3(c), the Privacy rules at 45 CFR Part 164, if applicable, and standards set out in OMB Circular A- 130, Appendix III Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed. Unless AHRQ is able to negotiate exceptional arrangements, for the sole purpose of assuring that data confidentiality is maintained, included in the DUA is the requirement that the User agrees to submit to CMS, a copy of all findings within 30 days of making such findings. The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so. In developing research plans, applicants should allow time for refining, approving, and processing any CMS data requests. Requests may take 6 months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff. CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats. Questions regarding CMS data should be directed to the AHRQ program official listed under INQUIRIES. In carrying out its stewardship of research programs, the AHRQ, at some point in the future, may begin requesting information essential to an assessment of the effectiveness of Agency research programs. Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research. AHRQ expects grant recipients to keep the Agency informed of publications as well as the known uses and impact of their Agency- sponsored research. Applicants are to agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active. To receive an award, applicants must agree to submit an original and 2 copies of an abstract, executive summary, and full report of the research results in the format prescribed by AHRQ no later than 90 days after the end of the project period. The executive summary should be sent at the same time on a computer disk which specifies on the label the format used (WP5.1 or WP6.0 is preferable). PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness and responsiveness by the Agency Referral Officer, program staff, and grants management staff. Incomplete and/or non-responsive applications or applications not following instructions given in this PA will be returned to the applicant by the Agency Referral Officer without further consideration. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures. As part of the merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. REVIEW CRITERIA In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Investigator o Environment o Budget The scientific review group will address and consider each of these criteria in assigning your application's overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, is the proposed work likely to result in enhanced preparedness for a significant sector of the health care system? Will this project provide federal, state and local policy makers, and others participating in the formulation of plans and policies for bioterrorism and other public health emergency preparedness, with the evidence, models, and tools that will enhance preparedness activities? (2) APPROACH: Are the rationale, preliminary plans, interventions, model or tool development methodologies, testing, evaluation and disseminations or preliminary plans adequately described, suitably evidence-based, technically sound, well integrated, and appropriate to the aims of the project? Does the application acknowledge potential problem areas and consider alternative tactics? Will the proposed evidence, tools and/or models be relevant to bioterrorism and other public health emergency preparedness activities at the national, state, and local level? (3) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers? Does the proposed study team reflect an appropriate array of skills for the aims and evaluation and dissemination? Are the time commitment sufficient to accomplish the aims? Are roles clearly delineated and complementary? (4) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Is there evidence of institutional support? Is there any affiliation or a plan for affiliation of the organization or research team members with national, State, or local bioterrorism and other public health emergency preparedness partners that can enhance the likelihood of successful dissemination of the evidence, models, or tools developed? (6) BUDGET: The proposed project budget and the requested period of support in relation to the proposed research questions:? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: The adequacy of plans to address the need of both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the aims of the project. Adequacy of attention to other populations of special priority to AHRQ (see discussion on Priority Populations in the section on Special Requirements, above, and Inclusion Criteria included in the section on Agency policies and Requirements, below.) DATA SHARING: Data Confidentiality Pursuant to section 924(c) of the Public Health Service Act [42 USC 299c-3(c)], information obtained in the course of any AHRQ supported- study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute. [42 U.S.C.299c-3(d)] In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to the information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this PA will also be managed in accordance with 42 CFR Parts 160 and 164, federal regulations pertaining to the privacy of patient-related health information. These privacy regulations, developed by the Department of Health and Human Services pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA), are scheduled to be effective and enforceable in April 2003. These regulations serve to limit the disclosure of personally identifiable patient information and define when and how such information can be disclosed. Thus, for example, health care plans and providers will require either patient authorization of disclosures of identifiable information to be made to researchers who are not their health care providers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations) upon being satisfied that any identifiable health information will be appropriately safeguarded by the investigators. The awardee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds those established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application. Rights in Data AHRQ grantees may copyright unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable Federal government license to use and permit others to use these products and materials for government purposes. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, data bases, results, and algorithms available for verification or replication by other researchers; and subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Health Care Information wishes to be consulted in advance of publication in order to coordinate these issuances with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's website http://www.access.gpo.gov/nara/cfr/index.html). RECEIPT AND REVIEW SCHEDULE Technical Assistance Conference Call: July 2, 2003 Application Receipt Dates: July 17, 2003 January 14, 2004 January 14, 2005 January 17, 2006 (This Program Announcement expires on July 17, 2007 unless reissued.) Peer Review Date: August 2003 Earliest Anticipated Start Date: September 2003 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITATIONS INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS: It is the policy of AHRQ that women and members of minority groups be included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines. Investigators may obtain copies from the above sources or from the AHRQ Publications Clearinghouse, listed under INQUIRIES, or from the NIH Guide Web site http://grants.nih.gov/grants/guide/index.html. AHRQ Program staff may also provide additional information concerning these policies (see INQUIRIES). AHRQ also encourages investigators to consider including children in study populations, as appropriate. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FAIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FAIA. If no Federal act is taken, having the force and effect of law, in reliance upon an AHRQ supported research project, the underlying data is not subject to this disclosure requirement and under FAIA, 5 USC 552(b), disclosure of identifiable data from such study is exempted from disclosure under "the (b)(3) exemption." It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support. Proprietary data might also be exempted from FAIA disclosure requirements under "the (b)(4) exemption", for example, if it constituted trade secrets or commercial information. However, courts have generally not regarded a researcher's interest in "his" data as proprietary. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Should applicants wish to place data collected under this PA in a public archive, which can provide protections for the data (e.g., as required by the confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 299c-3(c)) and manage the distribution of non- identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/ NOT-OD-03-025.html. 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 health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance, Number 93.226. Awards are made under Title IX of the Public Health Service Act (42 USC 299-299c-7) as amended by P.L. 106-129 (1999). Awards are administered under the PHS Grants Policy Statement and Federal Regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 or 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. REFERENCES 1. Bravata DM, McDonald K, Owens DK. Bioterrorism: use of information technologies and decision support system. AHRQ Clearinghouse. 2001. 2. Catlett C, Perl T, Jenckes MW, Robinson KA, Mitchell D, Hage J, Fuererstein CJ, Chuang S, Bass E. Evidence report on training clinicians for public health events relevant to bioterrorism preparedness. AHRQ Clearinghouse. 2001. 3. Chen FM, Hickner J, Fink KS, Galliher JM, Burstin, H. On the front lines: family physician's preparedness for bioterrorism. J. Fam Pract 2002;51:745-50. 4. Garrett LC,. Magruder C, Molgard CA. Taking the terror out of bioterrorism: planning for a bioterrorist event from a local perspective. J Public Health Manag Pract. 2000;6(4):1-7. 5. Khan AS, Morse S, Lillibridge S. Public-health preparedness for biological terrorism in the USA. Lancet. 2000;356(9236):1179-1182. 6. Khan AS, Ashford DA. Ready or not preparedness for bioterrorism. N Engl J Med. 2001; 345(4):287-289. 7. Wetter DC, Daniell WE, Tesser DC. Hospital preparedness for victims of chemical and biological terrorism. Am J Public Health. 2001;91(5):710-716.

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