RFA-HS-03-002: LIMITED COMPETITIVE CONTINUATION FOR AHRQ CENTERS FOR EDUCATION AND RESEARCH ON THERAPEUTICS PROGRAM

LIMITED COMPETITIVE CONTINUATION FOR AHRQ CENTERS FOR EDUCATION AND RESEARCH ON THERAPEUTICS PROGRAM RELEASE DATE: May 8, 2003 RFA: HS-03-002 Agency for Healthcare Research and Quality (AHRQ) (http://www.ahrq.gov) CFDA: Number 93.226 LETTER OF INTENT RECEIPT DATE: June 16, 2003 APPLICATION RECEIPT DATE: July 15, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION: o Purpose of this Limited Competing Continuation o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions 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 PURPOSE OF THIS LIMITED COMPETING CONTINUATION RFA The Agency for Healthcare Research and Quality (AHRQ) announces the availability of limited competitive continuation funds for awards to existing Centers for Education and Research on Therapeutics (CERTs) whose initial funding commenced in 2000. The purpose of these awards is to allow these grantees to build on their current work in progress and to expand the work to: (a) develop and implement educational strategies focused on translating the most promising findings of current work into everyday practice; (b) address existing gaps within the overall CERTs program including pharmacoeconomics, cost effectiveness analyses, and education; (c) enhance the work of the CERTs, consistent with the AHRQ patient safety agenda; and (d) develop additional projects within each center's overarching center theme that was previously determined to be complementary to AHRQ research priorities and responsive to the needs and goals of programs of the Department of Health and Human Services (DHHS), as discussed below. This program began with the release of RFA: HS-99-004 on January 27, 1999, and the subsequent award of grants pursuant to the Food and Drug Administration Modernization Act of 1997 which authorized the AHCPR (now AHRQ), in coordination with FDA, to carry out a demonstration program to conduct research and provide objective information on drugs, biologics, and devices. AHRQ continues to manage this program under the Agency's reauthorizing legislation, P.L. 106-129, enacted in December 1999. The program's legislative mandate is to "conduct state-of-the-art research to increase awareness of: (1) new uses of drugs, biological products, and devices; (2) ways to improve the effective use of drugs, biological products, and devices; and (3) risks of new uses and risks of combinations of drugs and biological products." Further, the legislation directs "CERTs to provide objective clinical information to the following individuals and entities: (1) health care practitioners and other providers of health care goods or services; (2) pharmacists, pharmacy benefit managers and purchasers; (3) health maintenance organizations and other managed health care organizations; (4) health care insurers and governmental agencies; and (5) patients and consumers." Additionally the centers are to "investigate various ways to improve the quality of health care while reducing the cost of health care through an increase in the appropriate use of drugs, biological products, and devices and the prevention of adverse effects of drugs, biological products, and devices and the consequences of such effects, such as unnecessary hospitalizations." Finally, the CERTs will "conduct research on the comparative effectiveness, cost-effectiveness, and safety of drugs, biological products, and devices." CERTs is an ongoing multi-year program that supports research demonstration centers. The CERTs program is mandated by Congress. Because the existing CERTs recipients possess the infrastructure, leadership, organization, and multidisciplinary research objectives to enable them to build on the existing work to address existing gaps and to develop additional projects, and because continuity in the research is necessary, this will be a limited competition. In addition, ongoing evaluation of the CERTs demonstration activities require that a longer period of funding be in place for the current awardees in order to determine the appropriate structure for the permanent Agency program. Detailed information on the program can be obtained at http://www.ahrq.gov/clinic/certsovr.htm. RESEARCH OBJECTIVES Background The Centers for Education and Research on Therapeutics (CERTs) program is a national initiative to increase awareness of the benefits and risks of new, existing, or combined uses of therapeutics (defined as drugs, biologics and medical devices) through education and research. The CERTs concept grew out of recognition that physicians need more information about the therapies they prescribe. Although information is available through the private industry sponsored programs, continuing medical education programs, professional organizations, and peer-reviewed literature, comparative information about the risks and benefits of new and older agents, and about drug interactions is limited. The mission of the CERTs program is to provide objective, scientific information on the safe and effective use of therapeutics. The CERTs research centers (RC), Coordinating Center (CC), and Steering Committee (SC) work together to achieve these goals. The vision of the CERTs program is to become a trusted national resource for people seeking information about medical products. This is being accomplished through research and education by first developing knowledge and then sharing it with people who can use it to manage risk, improve practice, and inform policies. CERTs centers have participated in 100 projects to date, extending along broad spectra of research and educational efforts. Along the research spectrum, CERT center projects have included purely descriptive research, interventional research, and applied research. This represents a logical progression. Similarly, educational efforts have reflected a spectrum of efforts, including development of teaching modules, seminar presentations, fellowship programs, Internet-based materials, and one-on-one consultations for caregivers, policy-makers, regulators, and patients. The major objective of each center is to develop priorities for education and educational research in therapeutics, within its own "theme", a broadly defined therapeutics research area, such as therapeutics used within a particular type of health care setting or population. Guidance in developing these priorities, within the context of the missions of AHRQ and FDA, are listed below under the section on Special Review Criteria. The center will develop demonstration or pilot educational programs that meet these criteria and explain how these projects fit within a comprehensive plan to improve the use of therapeutics. Each center should develop objective, measurable, educational goals within its therapeutic theme. Each center should address its field as a whole and identify current and future goals. Each center should also address the critical issues of medical errors and patient safety. The Institute of Medicine (IOM) in November, 1999, released a report estimating that as many as 98,000 patients die as the result of medical errors in hospitals each year. Many of these adverse events are associated with the use of therapeutics, and are potentially preventable. The IOM estimates the number of lives lost to preventable medication errors alone represents over 7,000 deaths annually - more than the number of Americans injured in the workplace each year. According to this same report, one study found that approximately two in 100 hospitalized patients experienced a preventable adverse drug event, resulting in an average increase of $4,700 per admission. This report inspired a number of responses within the Federal Government. The Federal Quality Interagency Committee (QuIC), developed an action plan based on the IOM report. AHRQ sponsored a National Summit on Medical Errors and Patient Safety Research on September 11, 2000, and findings from the summit define the Agency's patient safety research funding priorities. A summary of the summit is available on the Agency's web page http://www.ahrq.gov/. The ultimate goal of the CERTs program is to provide access to therapeutics research and education programs, as described in the authorizing legislation, for all who need such access, throughout the spectrum of health care. The goal of the CERTs demonstration is to test various methods and develop pilot programs that will provide direction as to how the program's research and education goals can be achieved. In order to assist this program in achieving its goals, AHRQ commissioned an evaluation of the program. During the upcoming year, the Steering Committee will review this evaluation and develop a response so that the centers are able to maintain responsiveness to the CERTs authorizing legislation. Centers should review the evaluation. Proposals should address how the center will address the recommendations in the evaluation. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U18), an "assistance" mechanism in which substantial AHRQ and other government scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. This is a cooperative demonstration program. The dominant role and prime responsibility for all CERTS research 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, the coordinating center, the steering committee and the AHRQ Program Officials(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 "Terms and Conditions of Award." The total project period for applications submitted in response to the present request for competing continuation applications may not exceed four years. The projects may undergo program peer review to determine whether appropriate progress has been made at the end of year two of the award. FUNDS AVAILABLE The AHRQ expects to award up to $800,000 in total costs in fiscal year 2003 to each successful applicant. At least $200,000 total costs of the proposed budget should be allocated for projects consistent with the patient safety agenda developed by the individual center and consistent with the AHRQ patient safety agenda. A separate budget and budget justification must be submitted for each proposed project including those related to patient safety. Additional projects (e.g., patient safety or educational research) will be considered for funding pending availability of funds. These additional projects may not exceed a total cost budget of $200,000 per center. Thus, the proposed project budget should not exceed $1 million total cost per year. The total project period may not exceed 4 years. The anticipated award date is September 30, 2003. This program is provided for in the financial plans of AHRQ, but awards are contingent upon availability of funds. AHRQ has not determined whether or how this solicitation will be continued beyond the present RFA. ELIGIBLE INSTITUTIONS AHRQ will accept competing continuation applications from the three existing CERTs Centers with Cooperative Agreement Awards ending during FY2003. For-profit organizations are eligible to apply for cooperative agreement awards. They may also participate in the grant projects as members of consortia or as subcontractors. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. Competitive funding for new research centers will be deferred until AHRQ staff are able to determine appropriate new or modified program priorities and structure for the ongoing Agency program. SPECIAL REQUIREMENTS General The overall focus of each research center will continue to be a broad therapeutic area, such as a particular setting or population, rather than any single disease or condition. A center, for the purpose of this application, should maintain its initial focus. Minor modifications in focus, such as expansion into related areas, are acceptable. The chosen area must maintain both a strong research and educational component. o These centers should continue to evaluate, develop therapeutic options, research methods, and conduct state-of-the-art, clinical, laboratory and health services research in accordance with the research and education program objectives to increase awareness of the benefits, risks and effectiveness of new, existing, or combinations of therapeutics to improve practice. A fundamental program goal continues to be the development of freestanding continuing centers of therapeutics expertise that conduct research and educate health care providers, other health care decision makers, care givers, and patients, within their particular overarching focus. o It is expected that centers will continue to expand ultimately support larger research initiatives by combining CERTs funds with funding from other sources (e.g., government, private sector, foundation and corporate). Guidance on specific project choices Centers will focus on the overarching theme of developing, disseminating and implementing educational programs based on findings from previously funded CERTs research and other priority areas listed below. o The mission of the CERTs is consistent with the AHRQ patient safety agenda. Each center should explicitly develop patient safety projects consistent with its own theme. Applicants are encouraged to consult descriptions of the issues and definitions contained in "To Err is Human: Building a Safer Health System" and the report from the Quality Interagency Committee (QuIC). All are available at http://www.ahrq.gov/qual/errorsix.htm. In developing projects, the grantees may utilize the definition of medical errors provided by the QuIC report. o The 1999 AHRQ reauthorization specifically adds cost-effectiveness research to the list of responsibilities for the CERTs. Each CERTs center should incorporate measures of cost effectiveness into Core (defined as those funded completely or in part through AHRQ funding) projects where feasible. Applicants are encouraged to discuss issues related to cost-effectiveness with Joanna Siegel, Sc.D., Director, Research Initiative in Clinical Economics, jsiegel@ahrq.gov, 301-594-1485. o Each center should support career development of junior faculty and investigators through efforts to increase in-house expertise in the varied area of therapeutics. A program should encourage commitment to the future of therapeutics research. Partnerships that establish capacity for multidisciplinary career development programs involving multiple organizations, both public and private, are strongly encouraged. o Other useful basic guidance that may be helpful for choosing topics includes: (1) high incidence or prevalence in the general population or subpopulations, including racial and ethnic minorities, women and children; (2) significance to the Medicare, Medicaid and other Federal health programs; (3) high costs associated with a condition, procedure, treatment, or technology, whether due to the number of people needing care, high unit cost of care, or high indirect costs; (4) controversy or uncertainty about the effectiveness or relative effectiveness of available clinical strategies or technologies; (5) potential to inform and improve patient or provider decision making; (6) potential to reduce clinically significant variations in the prevention, diagnosis, treatment, or clinical management of a disease or condition, or in the use of a procedure or technology, or in the health outcomes achieved; (7) availability of scientific data to support the study or analysis of the topic; and (8) potential opportunities for rapid implementation. o Further guidance on potential areas of research of interest to AHRQ may be found at in the program announcements listed at http://www.ahrq.gov/fund/grantix.htm. o In addition to AHRQ's needs, FDA's needs relate to research into areas of more effective education of and communication with the clinical community. In particular, there is a crucial need for research to help understand the keys to recognition of adverse events and use error problems with medical products and to sensitize the clinical community toward this recognition. In addition, more research needs to be conducted on the most effective means of communicating product information (whether on labeling changes or in public health advisories) that would be incorporated quickly into clinical practice. o The chosen studies should have strong justification as to why this research and education will result in public health impact. The applicant will define how to best approach the issues of improving treatment in that particular area. In choosing projects, consideration should be given to the legislative mandate, as noted in the section on research objectives. In the justification, it should be noted how the project meets the goals of the legislation, and to quantitatively impact on public health. o Newly proposed projects should be multidisciplinary and may address various health care providers, settings, and geographic areas. Multidisciplinary research may involve scientists in medicine, pharmacology, epidemiology, engineering, pharmacy, nursing, human behavior, statistics, economics, organizational behavior and related fields. o Each proposed project should identify desired outcomes, identify method for measuring progress toward the goal and be linked to a plan for implementation. Administrative o Evidence should be presented of a continuing infrastructure capable of maintaining the CERTs center. Past or planned changes in the center and its team should be described in detail and a discussion of the impact of these changes should be included. o Each proposed project should identify desired outcomes, identify method for measuring progress toward the goal and be linked to a plan for implementation. Each center should submit well-developed, relevant new study protocols. However, it is expected that further research will continue to be developed for the duration of the project that will build on current research. o The applicant should summarize plans in the application for additional funding through private partnerships or additional government funding to assist in completing larger projects. For those projects where a non- governmental partner has been identified, the applicant should include in the application a description of the steps that have been taken to assure adherence to the principles set forth in the CERTs Principles for Public- private Partnerships. These principles can be viewed at the following web address http://www.certs.hhs.gov/partners/principles.html. o Programs developed for this application should show plans for how the research will be translated into specific, measurable outcomes. It should include a plan that describes the steps required to progress from developmental pilot programs to national programs that measurably affect outcomes. Results from these small pilot and developmental projects will ultimately be used by the centers, the CERTs program, DHHS, and other partners, to translate this developmental work into educational programs. A high priority should be given to translational activity that results in education and measurably improves health care, as measured by commonly accepted indicators, such as mortality, hospitalization rates, quality of life, or reduced resource utilization and quality of life criteria. A specific plan that identifies how this goal will be achieved should be developed. o In developing a research plan for the continuation-funding period, the center may consider gaps in research and education within its area of focus, such as laboratory research and its application to clinical medicine, research on the utilization of medical devices or new therapeutic methods or treatments and studies of cost-effectiveness. o A document that provides the priorities and criteria for the choice of projects within the theme of the CERTs center should be included in the application. Each center's application should outline how it expects to help AHRQ meet the overall goals of the program. In addition, each center should articulate the outcomes it expects to achieve as a result of the program of work being undertaken. o The AHRQ funds are intended to provide basic support for each center and to allow it to function effectively. This core funding will be provided for administrative and staff support to undertake the design, development and implementation of one or more educational studies and a dissemination program. o Detailed research plans which allow for the review of a discrete budget for each proposed major Core project should be presented within the application. o It is expected that core funding, as a component of the CERTs budget, will be expended in such a way as to allow more active participation on the part of the center teams in Steering Committee and AHRQ activities (e.g., seminars or workshops). In addition to budgeting for quarterly meetings, each center should budget for one trip to Rockville for two people from the center per year. At the discretion of AHRQ program staff; this trip may be used to fund investigator travel to another location. Additionally, a limited budget should be set aside, not to exceed 1% of the annual proposed total cost budget, for other collaborative activities. These activities may require rapid responses on the part of the investigator teams. Some examples of potential collaborative activities include assisting program staff in responding to questions related to a Medicare drug benefit, or participation in a workshop related to CERTs. o When proposed core projects (defined as projects funded by AHRQ) involve surveys that are not research center initiated or collection of survey data from individuals is required by AHRQ, plans should consider the applicability of the Paperwork Reduction Act 44 USC 3501ff and related regulations, 5 CFR 1320 [1320.3(h)(5) exempts collections of data from patients e.g., in clinical trials] and seek technical assistance from the agency, as needed, (e.g., as to the impact of these requirements on timing of these projects). o Should a center desire to embark on larger projects, not contained within the original application during the grant period, it would need to seek alternative funding sources or apply and compete for AHRQ funding. o Each center should provide a thorough evaluation of the accomplishments of its program. An appendix describing partnerships (both governmental and private) with products should be attached. Evidence should be presented that the center is serving the needs and meeting the objectives of the CERTs program such as support of the steering committee for its projects and the program as a whole. Have the activities of this center provided evidence to support the safe and effective use of therapeutics? o Accomplishments should be placed in the appropriate section of the proposal. Accomplishments should focus on peer-reviewed publications, presentations, and abstracts that support the goals of CERTs. Of particular importance is the determination of impact and importance of the publications. Has the research undertaken been high-impact with a high probability of translation into policy or clinical practice? Publications, to date, should be placed in an appendix, with a complete bibliography. o The application must present evidence that the institution continues to have a broad base of skills with demonstrated experience in multidisciplinary research, including clinical epidemiology, clinical pharmacology, health services research and analyses of large databases. Additional strengths would include schools of public health, medicine, nursing and pharmacy; a bioengineering program; a clinical pharmacology program, or a pharmacoeconomics program, from which to draw appropriate personnel. o CERTs should develop new and support existing public-private partnerships. These partnerships may be developed in conjunction with the CERTs Steering Committee, FDA and AHRQ. Applicants should show evidence of the ability to obtain additional funding in both the research plan and in the center accomplishments. The documentation of such collaborative arrangements will be a part of the review. Collaborators may include arrangements with partners such as other governmental agencies, professional groups, consumer groups, foundations, and pharmaceutical companies. Contributions of outside entities may include significant donation of investigator time, free access to computerized databases or computer time and personnel, free pharmaceuticals or other therapeutics or others as appropriate. o Peer review may be convened to review subsequent non-competing continuation applications. Reviewers will assist AHRQ program staff in doing midcourse reviews of these projects after two years. These reviews may be site visits or may simply consist of paper reviews. These reviewers will evaluate progress in fulfilling the requirements of this RFA. o The application must demonstrate the availability of personnel with the necessary expertise to study a wide range of topical areas in after-market medical product research and have experience in the areas of dissemination and evaluation of such. Applicants should show evidence of a continued appropriate administrative structure in place that enables it to complete projects in a timely fashion, with full accountability for funds. Priority Populations The Agency's authorizing legislation (refer to http://www.ahrq.gov/hrqa99a.htm) 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 announcement should address attention to these priority populations and outline potential benefits of proposed projects for any of them. 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) through the AHRQ program officer, when articles from their studies are accepted for publication in the professional literature. Grantees should also discuss their 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 institutions. In cases when products are created (such as annual or final reports, Web- based tools, CD-ROMs), grantees 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. Office of Health Care Information Contact Number: 301594-1360. TERMS AND CONDITIONS OF AWARDS These special Terms of Award are in addition to and not in lieu 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 and 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. This cooperative agreement (U18), is an "assistance" mechanism, in which substantial AHRQ scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the AHRQ purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Cooperative Activities are intended to strengthen the individual CERTs activities through data sharing, data access and through improved communication. All cooperative activities that potentially include significant government involvement will require prior approval by the AHRQ program official who is expected to consult with the SC. Awardee Rights and Responsibilities o The centers are expected to work with AHRQ, the FDA and other Federal Agencies, as appropriate, on analyses and studies. Such joint activities may involve syntheses of research findings, data analyses, or the preparation of background information on various topics related to therapeutics. o The Principal Investigator will work with the coordinating center, as appropriate, to disseminate study findings, including, but not limited to, publication in peer review journals. o Each Principal Investigator will attend the quarterly steering committee meetings, and the monthly conference calls chaired by the coordinating center. One co-investigator from the center will be designated in the application to act and make decisions related to Steering Committee business, in the absence of the Principal Investigator. o The Principal Investigator will provide access to the various center data sources to the coordinating center and to AHRQ as appropriate to the individual studies, consistent with statutorily based promises of confidentiality. o Publications and other pertinent information, such as educational modules, should be submitted to the coordinating center as soon as they are available via both direct transmittal and hard copy. o Submission of a semi-annual report of progress to the responsible AHRQ program official. Federal Agency Responsibilities o AHRQ and FDA representatives will participate as permanent members of the steering committee. Other government agencies may also be invited by the Steering Committee Chair to become members of that committee. o AHRQ with assistance from FDA, the CC, and the research centers will identify a chair for the steering committee, should the current chair resign. o The AHRQ Program Official(s) will work in conjunction with FDA, the centers' principal investigators, the coordinating center and the Steering Committee to assure that issues for further study receive adequate review. Government representatives will also meet periodically to provide input and advice to the Steering Committee. o The Federal agencies will on occasion have substantive involvement in the planning and conduct of research, technical assistance, dissemination, and career development carried out by each center. Such involvement will require the approval of the AHRQ Program Official and such research may require further approval by OMB. o The Federal agencies involved will provide information on appropriate government resources, such as additional funding and data sources. o The Federal agencies involved will work with the center staff to facilitate dissemination of results. o As additional data and sources of funding are identified, the Federal agencies will work with centers, through the Public Private Partnership working group to establish appropriate agreements to optimize use and sharing of these resources. o AHRQ reserves the right to terminate or curtail any study or an entire award in the event of substantial lack of progress or lack of participation in CERT-related activities. WHERE TO SEND INQUIRIES AHRQ encourages inquiries concerning this limited competing continuation and welcomes the opportunity to answer questions from applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your inquiries about scientific/research issues to: Lynn Bosco, MD, MPH 6010 Executive Blvd., Suite 300 Rockville, MD 20852 Phone: 301 594 2416 E-mail: Lbosco@ahrq.gov o Direct your questions about peer review issues to: Veronica M. Friel, Ph.D. 2101 East Jefferson Street, Suite 400W Rockville, MD 20852 Phone: 301 594 6225 E-mail: vfriel@ahcq.gov o Direct your question about financial or grants management matters to: Michelle Burr 2101 East Jefferson Street, Suite 601 Rockville, MD 20852 E-mail: mburr@ahrq.gov 301-594-1840 SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://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. SUPPLEMENTAL INSTRUCTIONS Because of the complexity of the issues required in this application, applicants are allowed an additional five pages beyond the usual twenty-five maximum for the research plan. 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 five 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) APPLICATION PROCESSING Applications must be received by the receipt date listed in the heading of this Limited Competing Continuation. If an application is received after that date, it will be returned to the applicant without review. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. The Center for Scientific Review (CSR) and AHRQ will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. Applicants are encouraged to read all PHS Forms 398 instructions prior to preparing an application in response to this announcement. The PHS 398 type size requirements will be enforced rigorously and non-compliant applications will be returned. Institutional Review Board (IRB) approval of human subjects' protection is not required but is recommended 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. (https://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). This announcement is 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 this announcement number). This announcement 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. 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 the AHRQ Program Officer 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 to the RFA. Incomplete and/or non-responsive applications or applications not following instructions given in this RFA will be returned to the applicant without further consideration. An appropriate peer review group convened in accordance with standard AHRQ Special Emphasis Panel (SEP) peer review procedures will evaluate applications that are complete and responsive to the RFA for scientific and technical merit. As part of the merit review, all applications will: o Receive a written critique o Undergo a preliminary screening 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 Innovation 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. For example, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study assist AHRQ in meeting the goals of the overall CERTs program? How does the project you are proposing address the current gaps in knowledge about the important problem identified in your original application? What are the specific outcomes which will be achieved if the aims of your application are realized? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) 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 (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? (6) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the application will also be reviewed with respect to the following: (1) PROTECTIONS: The adequacy of the proposed protection for humans, in terms of protecting privacy, disclosing risk, obtaining informed consent, and guarding against harm or injury. If applicable, the adequacy of protection for the environment, to the extent it may be adversely affected by the project proposed in the application. (2) INCLUSION: The adequacy of plans to address the needs of both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the aims of the project. (3) Adequacy of attention to other populations of special priority to AHRQ, as discussed in SPECIAL REQUIREMENTS, above. (See also Inclusion Criteria included in the section on Federal Citations, below.) (4) RELEVANCE TO LEGISLATIVE MANDATE: Reviewers will also consider the extent to which the projects outlined in your proposal will assist AHRQ in achieving the overall goals of the CERTS: potential of the proposed activity to foster and sustain innovation in the long-term; the degree to which the proposed activity will stimulate new innovation opportunities for the partner organizations; the degree to which the participation of the institutions that serve groups currently underrepresented in the scientific workforce are involved in the proposed activity. 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-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made or implied regarding the possible uses and disclosures of such data. 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. 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/handbook.pdf. The application of these confidentiality and security standards to subcontractors and vendors, if any, should be addressed. Rights in Data AHRQ grantees may copyright 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 research 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. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in the AHRQ's grant 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). SPECIAL REVIEW CRITERIA Special Review Criteria for these applications will be the fulfillment of items listed in the Special Requirements section of this RFA. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 16, 2003 Application Receipt Date: July 15, 2003 Peer Review Date: August 2003 Earliest Anticipated Award Date: September 29, 2003 AWARD CRITERIA Applications will compete for available funds with all other applications under this RFA. The intent of this RFA is to continue funding technically and scientifically meritorious centers unless there is reason to question the applicant's ability to participate in the program's cooperative activities. The following will be considered in making funding decisions: 1) quality of the proposed project as determined by peer review; 2) program balance; 3) availability of funds; and, 4) potential impact of proposed research. AHRQ reserves the right to fund all or part of any application. 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 https://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at https://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 https://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 (FOIA) 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 FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. It is not likely that data gathered under projects supported through this initiative will be used as a basis for federal regulation or action having the force and effect of law. However, 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-3c) 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 https://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.

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