CENTERS FOR EDUCATION AND RESEARCH ON THERAPEUTICS Release Date: January 27, 1999 RFA: HS-99-004 March 14, 2011 - This RFA has been reissued as RFA HS-11-004. (Reissued as RFA-HS-07-004) P.T. Agency for Health Care Policy and Research Letter of Intent Receipt Date: February 19,1999 Application Receipt Date: April 22, 1999 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications from nonprofit organizations to establish Centers for Education and Research on Therapeutics (CERTs). CERTs is a three-year program that will support demonstration Centers. These Centers will evaluate, develop options and methods, and conduct and perform pilot studies. These studies will consist of state-of-the-art clinical, health services, or laboratory research to increase awareness of the benefits, risks and effectiveness of new uses, existing uses, or combined uses of therapeutics. This demonstration program seeks new and more effective ways to develop, translate and disseminate objective information on therapeutics to health care providers and other decision makers to improve practice. In addition, CERTs may selectively develop protocols and possibly undertake pilot studies on the comparative cost effectiveness and safety of medical products. This will be accomplished with data on appropriate therapeutic usage and outcomes, and the identification and prevention of medical errors and adverse effects. The long term goal of the program will be to improve the quality of care while reducing costs. Congress expanded the authority of the AHCPR under the Food and Drug Administration Modernization Act of 1997 (P.L. 105-115), to conduct a three- year demonstration program to conduct research and provide objective information on drugs, biologics, and devices. The research centers (CERTs) are created under Sec. 409 which adds a new section (Sec. 905) to the authorizing statute for AHCPR (Public Health Services Act Title IX--42 U.S.C. 299 et seq.). AHCPR will administer a demonstration program, in close consultation with the Food and Drug Administration (FDA). Coordination with FDA will be through the AHCPR CERTs Program Official. For the purposes of this document, therapeutics are defined as drugs, biologics, and devices. A Center is defined as an organization with a core group of investigators with either institutional or similar kinds of professional bonds who have strong experience in the area of research in therapeutics. The center may be a consortium of organizations, although it is expected that members of a consortium will provide collateral or supplemental support to the applicant organization. HEALTHY PEOPLE 2000 The Public Health Services (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS- led national activity for setting priority areas. AHCPR encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001- 00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone 202/512-1800. ELIGIBILITY REQUIREMENTS Applications may be submitted by public or private non-profit organizations including universities, clinics, units of state and local governments, non- profit firms, and non-profit foundations. For-profit organizations may participate as members of consortia or subcontractors if the applicant is non- profit. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible. AHCPR encourages women, members of minority groups, and persons with disabilities to apply as Principal Investigators. 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 AHCPR scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the AHCPR 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. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreements are discussed later in this document under the section "Terms and Conditions of Award." The anticipated award date is September 29, 1999. At this time, AHCPR has not determined whether or how the solicitation will be continued beyond the present RFA. FUNDS AVAILABLE The AHCPR expects to award up to $2 million in Fiscal Year 1999 to support 4-6 centers. The total project period may not exceed 3 years. One of the Centers will be selected to perform additional functions as a Coordinating Center. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of awards will also vary. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. RESEARCH OBJECTIVES Background The large, for-profit, medical product industry in the United States is unique because of the long-standing, co-existence of the dual missions of maintaining and improving public health and increasing profits. For the most part this has worked well (society has benefitted from new and better therapeutics and the economy has prospered). When problems have arisen in the system, the government has stepped in to provide regulation. Therapeutic products have contributed to improving the health and quality-of- life of the American people and new medical products are constantly being developed to combat and prevent major health problems. Each year over 2 billion prescriptions are written in the U.S. and many medical devices are used. At the same time that medical products improve the lives of many, significant numbers of adverse events and inappropriate product use cause serious impairment to the health of others. Guidance on appropriate product use, prevention of errors and adverse effects, and cost effective use of new and existing products is limited, thus indicating there is a need by health professionals for more complete information about the drugs and biologics they prescribe and the devices that they use, as well as a need to improve practices associated with their use. The FDA regulates most currently marketed therapeutics., In order for marketing to occur, for most drugs and biologics, pre-marketing studies must be completed, with final approval for marketing contingent on manufacturers providing FDA evidence of safety and efficacy for a single indication through adequate and well-controlled studies. The majority of devices receive clearance rather than approval after the manufacturer provides evidence that the product is substantially equivalent to a device that is already on the market. FDA regulation continues during the post-approval phase, through post marketing safety monitoring and through regulation of advertising. The AHCPR activities related to therapeutics begin after product approval through support of research on the relative effectiveness, appropriateness, and cost effectiveness of various strategies for the prevention, diagnosis, treatment, and management of clinical conditions. Activities have included development and administration of a program to study patient outcomes, development of evidence based practice centers, and support of the development of quality measures. SPECIAL REQUIREMENTS There are two types of Centers that the AHCPR intends to fund. Research centers will be devoted to research and dissemination activities. One research center will receive additional funds to act as a coordinating center. Research Center The overall focus of each center will be on 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 choose to focus on a broad therapeutic area. The chosen area should have both a strong research and educational component. It is expected that centers will select areas with a high likelihood of potential impact on practice. o These centers will evaluate, develop options and methods, and conduct state-of-the-art, clinical, laboratory and health services research. The purpose of this research and education program is to increase awareness of the benefits, risks and effectiveness of new, existing, or combinations of therapeutics to improve practice. o CERTs may selectively develop protocols and undertake pilot studies on the comparative effectiveness and safety of medical products. o The program goal will be development of free-standing continuing centers which conduct research and educate health care providers and other decision makers. These centers should have as their goal improved use of drugs or medical devices with a concomitant decrease in errors and adverse events. o The AHCPR funds are intended to provide basic support for each center and to allow it to function effectively. Core funding will be provided for administrative and staff support, and a dissemination program. Research projects also may be supported in their initial stages with core funds. It is expected that Centers will ultimately support research with funds obtained from sources other than the CERTs demonstration program funds. These will include funding through other AHCPR awards, other federal agency grants, foundations, and other funding, as appropriate. o As noted, review criteria include reference to the proposed Center"s plans to attract and retain other funding sources in support of its research projects. o Applications are encouraged from existing Centers receiving funds from AHCPR, other governmental agencies, or private sources(e.g., Centers funded through the National Center for Research Resources, General Clinical Research Center program or the Centers for Disease Control and Prevention, Prevention Centers). o Centers are expected to have access to resources that would allow study of a wide spectrum of therapeutic issues in the chosen area. However, specific topic areas, in keeping with the limited availability of funds, will be negotiated prior to funding. These negotiated topic areas will be aimed at having program balance and diversity in the areas covered by the CERT program. Coordinating Center One of the funded CERTs will be designated as a coordinating center (CC). A research center applicant who desires to be considered to fulfil the role of coordinating center should (a) state that intent in the application, and (b) include a section with a budget to support these activities. Those research centers funded without the coordinating function would have that portion of their application deleted for funding purposes. The coordinating center will have the following functions: o Establishment of a steering committee (SC). The SC will consist of members from all the Centers, AHCPR and FDA. It will be chaired by a national expert, chosen by FDA and AHCPR, with the concurrence of the research centers. Other members with appropriate expertise, will also be appointed. Organizing and convening this committee will be the responsibility of the CC. This SC will act in a consultative role to all the Centers. The SC will organize and provide funding for meetings, to be held 2-4 times per year as needed. Travel will be coordinated through this Center. The steering committee will also likely need to meet via periodic conference calls. o Identification and employment of an appropriate staff person who will be hired to act as a data and information coordinator and specialist for all the research centers. This will be a person funded and supervised through the CC, but, will work mostly with the federal agencies involved in CERTs and other data providers as necessary. This person should be familiar with and be able to facilitate the use of government data sources, such as New Drug Application Files at the FDA, the Medical Expenditure Panel Survey at AHCPR and Medicare data files from Health Care Financing Administration. This person will be shared equally by all of the centers. This person will act as a liaison between the Centers and the federal agencies involved. o The CC will work with the AHCPR Program Official, FDA representative(s) and the SC Chair to enhance synergy across the goals and projects of each of the research centers. o The CC will identify opportunities for engaging research centers in addressing common methodologic and technical challenges. o The CC will identify opportunities to disseminate and implement information developed by research centers on a large scale. It will also identify opportunities to coordinate with and enhance activities of other national efforts to improve the use of therapeutics, e.g., the National Patient Safety Foundation, quality improvement efforts of large health care systems, and the Institute for Healthcare Improvement. o Identification and sharing of resources. It will be the responsibility of the CC to determine whether other economies of scale can be identified and developed for the CERTs program. The CC will also coordinate efforts to identify additional funding for the program. o The CC will be the major focus of national dissemination and educational activity of the program. The CC will develop options to transfer knowledge from the Centers to "opinion leaders" and "change agents" in the health care system, and implement specific strategies to assure that the information is disseminated broadly and efficiently. These activities would be in addition to the existing AHCPR dissemination activities. o The CC will submit an annual report on the CERT implementation effort. Qualifications Research Centers o The organizational structure of each center should include a committed core of investigators who have access to a defined population. Information on this population should include demographics, diagnostic information and therapeutic usage. The Center may be a consortium of organizations, although it is expected that members of a consortium will provide collateral or supplemental support to the applicant organization. o The center must have access to data that will allow for the identification of problems associated with the use of therapeutics and also allows for the evaluation of any planned interventions (e.g., Medicaid or managed care administrative databases). The Center must have experience using the data as evidenced by publications or other products. o Applicants must have the scientific, technical, organizational and physical resources, or demonstrate access to such resources, necessary to carry out the following projects: (1) multidisciplinary research, including clinical epidemiology, health services research, analyses of large databases, and clinical pharmacology, as appropriate to the area of focus, (2) technical assistance to health care providers and others, (3) professional education, and (4) dissemination of research finding, and (5) the evaluation of dissemination strategies. (6) The organization should have a strong understanding of the regulatory process as it relates to product effectiveness and safety. o The center director must be an experienced senior investigator and manager who can provide strong administrative and academic leadership. The center director will be responsible for the organization and operation of the center, liaison with the research community and outside entities such as professional societies, subcontractors, and consumer groups, and communication with the AHCPR on scientific and operational matters. Personnel and institutional resources capable of developing and maintaining a substantial commitment to patient outcomes research must be available. The Center may consist of core staff with significant time commitments to the Center and affiliate staff with lesser time commitments. Multidisciplinary collaboration among researchers working within the Center is essential, each application must contain a plan to assure continuing interaction an participation among the Center"s researchers. o Work carried out by each Center is to be multidisciplinary and must 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. The long term goal of the program will be to improve the quality of care while reducing costs. o Each CERT must have a business plan which has as its goal development of a free standing program to carry out the various activities identified in the statute on a long term basis beyond the three years of the AHCPR funding. Coordinating Center The CC will require all of the qualifications above. Additional qualifications will include: o The Center will have demonstrated expertise in dissemination and translation of research on therapeutics into practice. o The Center has demonstrable evidence of a sophisticated understanding of health care systems and current quality improvement strategies. o The Center should have experience in working with health system leaders to translate research into practice, with potential for developing partnerships between the research centers and health care systems to enhance opportunities for broad scale implementation. o The Center should have experience in leading multi-center research teams. Terms and Conditions of Award 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. The administrative and funding instrument to be used for this program will be a cooperative agreement (U18), an "assistance" mechanism, in which substantial AHCPR scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, The AHCPR 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. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees, the AHCPR Project Scientist, and the FDA. Cooperative Activities are intended to strengthen the individual CERTs activities. Data sharing, data access and facilitate communications. Through the CC and the steering committee joint decisions regarding the program can be made. All cooperative activities will require prior approval by the steering committee. Awardee Responsibilities o The centers are expected to work with AHCPR, 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 be responsible for appropriate dissemination of study findings, including, but not limited to, publication in peer review journals. o Each Principal Investigator will attend the quarterly steering committee meetings, and other meetings as required. o The Principal Investigator will provide access to the various center data sources to Coordinating Center as appropriate to the individual studies. o Submission of a quarterly report of progress to the responsible AHCPR program official. AHCPR and FDA Responsibilities o AHCPR and FDA representatives will be members of the steering committee. o AHCPR and FDA will identify a chair for the steering committee. o The AHCPR Program Official(s) will work in conjunction with FDA, the centers" principal investigators, the coordinating center and the steering committee to develop issues for further study. o The Federal agencies will have substantive involvement in the planning and conduct of research, technical assistance, dissemination, and training carried out by each center. o The Federal agencies involved will facilitate access to appropriate government data sources through the CC. o The Federal agencies involved will work with the center employees to facilitate dissemination of results. o As additional data and sources of funding are identified the Federal agencies will work with Centers to establish appropriate agreements to optimize use and sharing of these resources. o AHCPR reserves the right to terminate or curtail the study or an individual award in the event of substantial lack of progress or lack of participation in CERT-related activities. Data Privacy Information obtained in the course of this study that identifies an individual or entity must be treated as confidential in accordance with section 903(c) of the Public Health Service Act (42 U.S.C.299a-1). Applicants must describe in the Human Subjects section of the application procedures for ensuring the confidentiality of identifying information. 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 will be safeguarded. Rights in Data AHCPR 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 AHCPR funds. Such copyrights and patents are subject to a Federal Government license to use and permit others to use these products and materials for AHCPR purposes. In accordance with its legislative dissemination mandate, AHCPR purposes may include, subject to statutory confidentiality protections, making research materials, data bases, and algorithms available for verification or replication by other researchers, and subject to AHCPR budget constraints, final products may be made available to the health care community and the public by AHCPR, or its agents, if such distribution would significantly increase access to a product and thereby produce public health benefits. Ordinarily, to accomplish distribution, AHCPR publicizes research findings but relies on grantees to publish in peer-reviewed journals and to market grant- supported products. INCLUSION OF WOMEN, MINORITIES, AND CHILDREN IN RESEARCH STUDY POPULATIONS INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups be included in all AHCPR-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 "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and printed in the NIH GUIDE of March 18, 1994. AHCPR follows the NIH Guidelines, as applicable. Investigators may obtain copies from these sources or from the AHCPR contractor, Equals Three Communications, Inc., listed under "Inquiries." AHCPR also encourages investigators to consider including children in study populations, as appropriate. AHCPR announced in the NIH Guide of May 9, 1997, that it is developing a policy and implementation plan on the inclusion of children in health services research. This Notice is available through the AHCPR web site http://www.ahcpr.gov (Funding Opportunities) and InstantFAX (see instructions under INQUIRIES. AHCPR program staff may also provide information concerning these policies (see INQUIRIES.) LETTER OF INTENT Prospective applicants are asked to submit, by February 19, 1999, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, other key personnel and other participating organizations or institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the consideration of any subsequent application, the information allows AHCPR staff to estimate the potential review workload and avoid conflicts of interest in the review. AHCPR will not provide responses to letters of intent. The letter of intent is to be sent to: Joanne S. Book Center for Outcomes and Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 APPLICATION PROCEDURES Applicants should use the research grant application form PHS 398 (rev. 4/98) in applying for these grants. State and local government applicants may use form PHS-5161-1, Application for Federal Assistance (rev. 5/96), and follow those requirements for copy submission. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, e-mail: grantsInfo@nih.gov. AHCPR applicants can also obtain application materials from the AHCPR contractor: Equals Three Communications, Inc. (see Inquiries) The RFA label available in the form PHS 398 (rev. 4/98) application must be affixed to the bottom of the face page of the original application. Failure to do so could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The PHS 398 type size requirements will be enforced rigorously and non- compliant applications returned. 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 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies, labeled "Advanced Copies" must also be sent to: Joanne Book Center for Outcomes and Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Applications submitted under this RFA must be received in the Center for Scientific Review, NIH, by April 22, 1999. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with AHCPR peer review procedures. If the application is not responsive to the RFA, it will be returned to the applicant without review. As part of the merit review, all applications will receive a written critique, and also may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score. General Review Criteria Review criteria for AHCPR grant applications are: significance and originality from a scientific and technical viewpoint, adequacy of the method(s), availability of data or proposed plans to collect data required for the project, adequacy of the plan for organizing and carrying out the project, qualification and experience of the Principal Investigator and proposed staff, reasonableness of the proposed budget and duration, adequacy of the proposed facilities and resources available to the applicant, the extent to which women, minorities and children (as appropriate), are adequately represented in study population, and when applicable, the adequacy of the proposed means for protecting human subjects. Special Review Criteria Research Centers Of all the criteria set forth, the infrastructure and capacity of the applicant are the most important criteria. Capacity should include evidence of the ability to provide rapid production of information, the ability to link geographically and demographically diverse sites of care, the ability to access a longitudinal and large database, and the capability for accessing and interfacing with the delivery systems. o The applicant institution will have a broad base of skills with demonstrated experience in multidisciplinary research, including clinical epidemiology and 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 Successful applicants must have 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. Preference will be given to primary applicants who currently devote a major portion of their resources to working on drug, biologics or medical device research and dissemination. o Applicants will have an appropriate administrative structure in place that will enable it to complete projects in a timely fashion, with full accountability for funds. o Applicants will need to develop additional funding prior to submitting the application. The documentation of such collaborative arrangements will be a part of the review criteria. 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 The Center director must be an experienced senior investigator and manager who can provide strong administrative and academic leadership. o The Center must have access and demonstrated experience with appropriate data. Therapeutic areas chosen by applicant centers will be evaluated using the criteria listed below. o A Center, for the purpose of demonstrating expertise, capacity, and existence of infrastructure, should choose a broad therapeutic issue. The chosen area should have both a strong research and educational component. The applicant will define how to best approach the issues of improving treatment in that particular area. In choosing an area, consideration should be given to the priorities of AHCPR and FDA. The therapeutics field is vast, but some examples of areas that exemplify the nature and scope of focus include: pediatric drug usage and safety, assessment and prevention of overuse of antibiotics, vaccine usage and safety, development and dissemination of cost- effective strategies for reduction of medication errors, or evaluation of patterns of use and education on the safety of implantable medical devices. These are merely a few examples and applicants should not limit their choices to these examples. o Other useful guidance that may be helpful for choosing topics chosen include: (1)high incidence or prevalence in the general population or in 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. Consideration of topic areas will be evaluated based on FDA priorities. Essentially 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 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 it be information on labeling changes or public health advisories) that would be incorporated quickly into clinical practice. Additional Criteria for Coordinating Center o The applicant for the coordinating center will need to have a history of involvement in multi-center research or similar programs. o The CC applicant will need to have strong skills in program evaluation, and strong experience in a wide variety of data, including cost data and other sources of information related to therapeutics. o Thee CC will need to have identified personnel with expertise in the unique aspects of data available through the various government agencies (FDA, AHCPR, etc.). o The center should have experience in working with health system leaders to translate research into practice, with potential for developing partnerships between the research centers and health care systems to enhance opportunities for broad scale implementation. AWARD CRITERIA Applications will compete for available funds with all other applications under this RFA. The following will be considered in making funding decisions: 1) quality of the proposed project as determined by peer review, 2) program balance, and 3) availability of funds. INQUIRIES Applicants are encouraged to use AHCPR"s Web site (http://www.ahcpr.gov) and FDA"s Web site (http://www.fda.gov) to learn about pertinent major initiatives in this area. This will help assure that new applications build on existing research, as appropriate, and are not unnecessarily redundant with currently supported research. Copies of this RFA are available from: Equals Three Communications, Inc. 7910 Woodmont Avenue, Suite 200 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 The RFA is available on AHCPR"s Web site http://www.ahcpr.gov (Funding Opportunities) and through AHCPR Instant FAX at 301/594-2800. To use Instant FAX, you must call from a facsimile (FAX) machine with a telephone handset. Follow the voice prompt to obtain a copy of the Instant FAX table of contents, which has the document order number (not the same as the PA number). The RFA will be sent at the end of the ordering process. AHCPR Instant FAX operates 24 hours a day, 7 days a week. For questions about this service, call Judy Wilcox, Office of Health Care Information, at 301/594-6344. AHCPR welcomes the opportunity to clarify any issues or questions from potential applicants. Written and telephone inquiries are encouraged. Direct inquiries regarding programmatic issues, including information on the inclusion of women, minorities, and children in study populations, to: Lynn Bosco Center for Outcomes and Effectiveness Research Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 605 Rockville, MD 20852-4908 Telephone: (301) 594-2416 FAX: (301) 594-3211 Email: email@example.com Direct inquiries regarding fiscal matters to: Joan Metcalfe Grants Management Specialist Agency for Health Care Policy and Research 2101 East Jefferson, Suite 601 Rockville, MD 20852-4908 Telephone: (301) 594-1841 FAX (301) 594-3210 Email: firstname.lastname@example.org AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Number 93.226. Awards are made under authorization of Title IX of the Public Health Service Act (42 U.S.C. 299-299c-6) and Section 1142 of the Social Security Act (42 U.S.C. 1320b-12) as applicable. Awards are administered under the PHS Grants Policy Statement and Federal regulations 42 CFR 67, Subpart A, and 45 CFR Parts 74 and 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 child 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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