From owner-sci-resources@net.bio.net Fri Mar 03 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 24, no. 8, pt. 1of1, 3 March 1995 Date: 3 Mar 1995 16:47:15 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 621 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3j8daj$3fi@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID NIHGUIDE 19950303 V24N08 P1O1 ************************************ X-comment: RFAs described: AI-95-012 NIH GUIDE - Vol. 24, No. 8 - March 3, 1995 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT Department of Health and Human Services INDEX: DEPARTMENT OF HEALTH AND HUMAN SERVICE $$INDEX N2 ********************************************************** NATIONAL SURVEY OF LABORATORY ANIMAL USE, FACILITIES, AND RESOURCES CONDUCTED BY THE NCRR IN 1995 National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX N3 ********************************************************** SMALL BUSINESS INNOVATION RESEARCH National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX N4 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION $$INDEX N5 ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 ********************************************************** DYNAMICS OF HEALTH, AGING AND BODY COMPOSITION - COORDINATING UNIT (RFP NIH-AG-95-03) National Institute on Aging INDEX: AGING $$INDEX R2 ********************************************************** LABORATORY TESTS OF BLOOD AND URINE SAMPLES FROM THE CPEP CLINICAL TRIAL (RFP NICHD-DESPR-95-14) National Institute of Child Health and Human Development INDEX: CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX R3 07/18/95 ************************************************* HEPATITIS C COOPERATIVE RESEARCH CENTERS (RFA AI-95-012) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES This publication is available electronically via BITNET or INTERNET, by subscription, and is also on the NIH GOPHER (gopher.nih.gov). Alternative access is through the NIH Grant Line using a personal computer (data line 301/402-2221); contact Dr. John James at 301/594- 7270 for details. THE PUBLIC HEALTH SERVICE (PHS) STRONGLY ENCOURAGES ALL GRANT RECIPIENTS TO PROVIDE A SMOKE-FREE WORKPLACE AND PROMOTE THE NON-USE OF ALL TOBACCO PRODUCTS. THIS IS CONSISTENT WITH THE PHS MISSION TO PROTECT AND ADVANCE THE PHYSICAL AND MENTAL HEALTH OF THE AMERICAN PEOPLE. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 24, Number 8, March 3, 1995 P.T. 34; K.W. 1014004, 1014006 Department of Health and Human Services Notice is hereby given that the Office of Research Integrity (ORI) has made final findings of scientific misconduct in the following case: Aaron Apte, Stanford University: The Division of Research Investigations of the Office of Research Integrity (ORI), reviewed an investigation conducted by Stanford University into possible scientific misconduct on the part of Mr. Aaron Apte, a former technician in the Department of Cardiovascular Surgery. Mr. Apte and his research were supported by U.S. Public Health Service grants. ORI concluded that Mr. Apte fabricated data for research, by cutting >From a former coworker's notebook a scintillation counter printout, pasting it into his own notebook, and representing it as his own results from a different experiment on the binding of angiotensin to transfected cells. Mr. Apte has been debarred from eligibility for and involvement in grants as well as other assistance awards and contracts from the Federal Government for a period of three years. The fabricated research did not appear in any publications. INQUIRIES For further information, contact: Director Division of Research Investigations Office of Research Integrity 5515 Security Lane, Suite 700 Rockville, MD 20852 Telephone: (301) 443-5330 $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** NATIONAL SURVEY OF LABORATORY ANIMAL USE, FACILITIES, AND RESOURCES CONDUCTED BY THE NCRR IN 1995 NIH GUIDE, Volume 24, Number 8, March 3, 1995 P.T. 34; K.W. 0404021, 0780000 National Center for Research Resources The National Center for Research Resources of the National Institutes of Health is conducting the "National Survey of Laboratory Animal Use, Facilities, and Resources" of all Public Health Service (PHS) awardee institutions. This survey was mailed to the Institutional Officials of all OPRR-assured institutions, at the address indicated on the assurance, in January 1995. Data requested includes information on the characteristics of the organization, the species and numbers of animals in the program, the facilities and personnel supporting the laboratories, and the costs of animal care. In order to maintain the confidentiality of the responses, the survey will be anonymous. The final report, which will be sent to each institution in late 1996, will contain aggregated data gathered from the responding institutions. The survey is being performed by Advanced Resource Technologies, Inc. During the survey response period, February 1 to March 17, staff of Advanced Resource Technologies, Inc. will maintain a toll free number -- 1-800-NIH-2494 -- to offer assistance to respondents with any questions about the survey. The survey information will be of great importance to the NIH in determining the impact of animal resource needs on biomedical research and the future funding of laboratory animal research, facility construction, and renovation programs. Each institution is strongly urged to participate in the survey process, since the value of aggregated information rests on a significant response from the PHS awardee institutions. INQUIRIES For toll free assistance with questions about the survey or guidance in filling out the form: Dr. Elizabeth Gard or Dr. Paul DiTullio Advanced Resource Technologies, Inc. Telephone: (800) NIH-2494 Ms. Carol Brown National Center for Research Resources Building 12A, Room 4047 Bethesda, MD 20892-5666 Email: carolb@od12A.ncrr.nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** SMALL BUSINESS INNOVATION RESEARCH NIH GUIDE, Volume 24, Number 8, March 3, 1995 P.T. 34; K.W. 0750020, 1003006, 0740022, 0710070 National Institute of Child Health and Human Development One program description for the Omnibus Solicitation of the Public Health Service for Small Business Innovation Research (SBIR) Grant and Cooperative Agreement Applications (PHS 95-3) was inadvertently omitted. The text, as it appears under the heading "B. Contraceptive Development" pertains to "C. Contraceptive and Reproductive Evaluation". Thus, on page 63, under "Contraceptive Development", the text should read as follows: B. Contraceptive Development Research focussed on new and improved methods of fertility regulation, for men and for women, that are safe, effective, inexpensive, reversible, and acceptable. The objective of the research is to develop an array of methods that couples in various population groups can use successfully and safely. (1) Synthesis and testing of drugs that can influence male and female fertility and that have the potential of becoming useful contraceptives. (2) Development of methods of contraceptive drug administration that can improve the bioavailability from different routes of administration. (3) Isolation of antigens specific to the reproductive system that could be utilized for antifertility vaccine development. (4) Development of improved barrier contraceptives for men and women, including new spermicidal agents or new formulations that may reduce vaginal irritation and provide better protection against sexually transmitted diseases. (5) Development of simplified methods to quantify sperm counts, particularly for men with low sperm counts. (6) Developing leads to non-peptide GnRH analogs (agonists and antagonists), as potential contraceptive agents, via screening of libraries of compounds against the GnRH receptor. C. Contraceptive and Reproductive Evaluation INQUIRIES For further information regarding this program, contact: Ms. Hildegard Topper National Institute of Child Health and Human Development Building 31, Room 2A03 Bethesda, MD 20892-2425 Telephone: (301) 496-0104 FAX: (301) 402-1104 Email: ht20t@nih.gov $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NATIONAL ANIMAL WELFARE EDUCATION WORKSHOPS NIH GUIDE, Volume 24, Number 8, March 3, 1995 P.T. 42; K.W. 0201011, 1014003 National Institutes of Health The National Institutes of Health, Office for Protection from Research Risks is continuing to sponsor workshops on implementing the Public Health Service Policy on Humane Care and Use of Laboratory Animals. Each of the workshops scheduled for Fiscal Year 1995 will focus on a specific theme. The workshops are open to institutional administrators, members of Institutional Animal Care and Use Committees, laboratory animal veterinarians, investigators and other institutional staff who have responsibility for high-quality management of sound institutional animal care and use programs. Ample opportunities will be provided to exchange ideas and interests through question and answer sessions and informal discussions. DATES: March 12-14, 1995 TOPIC: Animal Care and Research: Challenges and Changes for the Institutional Animal Care and Use Committee LOCATION San Diego Princess 1404 West Vacation Road San Diego, CA 92109-7994 Telephone: (619) 274-4630 or (1-800) 344-2626 FAX: (619) 581-5929 SPONSORS Tufts University School of Veterinary Medicine Public Responsibility in Medicine and Research REGISTRATION Ms. Danielle Demko Public Responsibility in Medicine and Research 132 Boylston Street Boston, MA 02116 Telephone: (617) 423-4112 FAX: (617) 423-1185 FEE: $300 DESCRIPTION: The Workshop will focus on revisions to the Institutional Animal Care and Use Committee Guidebook; assessment and reduction of pain and distress in animal research; occupational health risks ad biohazards; and a host of other regulatory and administrative issues that are central to the successful operation of laboratory animal care and research programs. Immediately preceding the Tufts University School of Veterinary Medicine/NIH/OPRR Workshop, Applied Research Ethics National Association (ARENA) will sponsor its annual animal issues meeting on Sunday, March 12, also at the San Diego Princess. INQUIRIES For further information concerning these workshops and future NIH/OPRR Animal Welfare Education Workshops, contact: Mrs. Roberta Sonneborn Office of Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, MSC 7507 Bethesda, MD 20892-7507 Telephone: (301) 496-7163 FAX: (301) 402-2071 $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 24, Number 8, March 3, 1995 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects, and will be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all Public Health Service agencies. The current schedule includes the following: DATES: May 4-5, 1995 TITLE: Contemporary Issues in Human Research Subject Protection in Vulnerable and Minority Populations: Sharing the Benefits and Burdens of Research LOCATION: Regal Riverfront Hotel, St. Louis, MO SPONSORS Washington University School of Medicine Jewish Hospital of St. Louis at Washington University Meharry Medical College REGISTRATION Barb Woodson Secretary, Research Administration Jewish Hospital of Saint Louis 216 South Kingshiway, Room 1768-69 Saint Louis, MO 63110 Telephone: (314) 454-8322 FAX: (314) 454-4241 REGISTRATION FEE: $150 DESCRIPTION: The HHS and FDA mandate to Institutional Review Boards is to protect the rights and welfare of human subjects while supporting scientific advancement. This protection is extended to all human subjects, but additional safeguards are provided by both the HHS/FDA regulations and basic ethical principles to protect the rights and welfare of vulnerable subjects who, by reason of their disability or illness, exhibit diminished personal autonomy. Neither the Federal regulations, nor ethical codes, including The Belmont Report, proscribe inclusion of vulnerable persons as research subjects, although special justification of any plan to involve vulnerable persons as research subjects is required. Women and members of certain racial groups -- particularly Afro-Americans and Hispanics -- have been excluded from research. Inasmuch as these groups have not been involved, they also are vulnerable -- vulnerable to exclusion and to the possibility of being deprived of proven new advances from research. This Conference will focus particularly on evolving concerns for the protection of vulnerable subjects from research risks, inappropriate or inadvertent exploitation, or discrimination by exclusion. Presentations will highlight FDA regulatory updates; explore the new guidelines for the inclusion of women and people of color and diverse racial and ethnic backgrounds in clinical research; examine the claims that women have been systematically excluded from research and potentially deprived thereby of proven diagnostic and therapeutic strategies; review current issues in research in vulnerable populations including unconscious patients in emergency rooms, AIDS patients, children, the elderly, and the cognitively-impaired. IRB challenges in research in psychiatry will be discussed, including the validity of initial and continuing informed consent for research in schizophrenic patients, justification for the use of a placebo, the social and medical implications of genetic screening for vulnerability to psychiatric disease, the ethical difficulties involved in research in child psychiatry, and the influence of cultural patterns on psychiatric research in minority populations. The Conference will include keynote addresses, panel presentations, facilitated forums, information exchanges, and active audience participation. An outstanding faculty of experts in each area of discussion has been selected on the basis of expertise and ability to communicate authoritatively and comprehensively. INQUIRIES For further information regarding these workshops and future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks National Institutes of Health 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20892-7507 Telephone: (301) 496-8101 FAX: (301) 402-0527 $$N5 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN NIH-AG-95-03 ********************************************* DYNAMICS OF HEALTH, AGING AND BODY COMPOSITION - COORDINATING UNIT NIH GUIDE, Volume 24, Number 8, March 3, 1995 RFP AVAILABLE: NIH-AG-95-03 P.T. 34; K.W. 0710010, 0755018, 0404021, 0413000 National Institute on Aging The National Institute on Aging (NIA) has a contract requirement to operate the coordinating unit for an eight-year population-based observational study, the Dynamics of Health, Aging and Body Composition (HEALTH ABC). The coordinating unit will interact with two field centers that will recruit a total of 3,000 non- institutionalized White and African-American men and women aged 70-79. Change in physical function and incident disability are the major study outcomes. Assessment of participants will include baseline and follow-up interviews and examinations that include measurement of body composition using dual energy x-ray absorptiometry (DEXA); measures of anthropometry, strength, fitness and physical function; objective measures of weight-related health conditions, i.e., osteoarthritis, cardiovascular disease, osteoporosis, pulmonary disease, and diabetes, and collection of blood and other biologic samples. The coordinating unit will have the primary responsibility for: (1) providing reading centers for body composition studies and electrocardiograms; (2) establishing and maintaining a central storage facility for biologic specimens; (3) identifying and assessing candidate facilities for analysis of biologic specimens; and (4) managing the central storage facilities and analytic laboratories for biologic specimens, including coordinating the shipping, tracking, and analysis of samples. Responsibilities for data management and study administration include: (1) participating with the field centers in preparing the study protocols, reporting forms, and manuals of operations; (2) assisting in the preparation of materials for OMB clearance; (3) developing a distributed data entry system; (4) standardizing, printing and distributing reporting forms, the study protocol, and manuals of operations; (5) conducting training sessions for field center personnel on all aspects of data collection; (6) receiving, collecting, processing, editing, storing, providing quality control of, and analyzing data collected by the field centers; (7) coordinating, arranging, participating in, providing information for, and preparing minutes from committee meetings; (8) preparing and distributing periodic technical and statistical reports; (9) developing recruitment plans, informed consent materials, and educational materials for diverse study populations; (10) collaborating with the other study investigators and project officers in producing manuscripts for publication. Applicants should have previous experience in research projects involving the following: collection of data on body composition or bone mineral density and from electrocardiograms, establishing and maintaining a central storage facility for biologic specimens, and evaluating laboratories for analysis of these specimens. The solicitation is scheduled to be issued on or about March 3, 1995. Proposals will be due 60 days after the date of issuance of the solicitation. All responsible sources may submit a proposal that will be considered by the Government. INQUIRIES Copies of the solicitation may be obtained by sending a written request to: John P. DeCenzo Research Contracts Branch, DCG/OD National Institutes of Health 6100 Executive Boulevard, Room 6E01 - MSC 7540 Bethesda, MD 20892-7540 Telephone: (301) 496-4487 $$R1 END ************************************************************ $$R2 BEGIN NICHD-DESPR-95-14 **************************************** LABORATORY TESTS OF BLOOD AND URINE SAMPLES FROM THE CPEP CLINICAL TRIAL NIH GUIDE, Volume 24, Number 8, March 3, 1995 RFP AVAILABLE: NICHD-DESPR-95-14 P.T. 34; K.W. 0755015, 0780005 National Institute of Child Health and Human Development As a part of the Trial of Calcium for Preeclampsia Prevention (CPEP), the National Institute of Child Health and Human Development (NICHD) is planning to (1) compare urinary excretion of calcium and related nutrients in preeclamptic women before and after the diagnosis of preeclampsia to that in normal pregnant women at comparable gestational ages, and determine the effect of oral calcium supplementation on the excretion of these substances; (2) determine the presence or absence of proteinuria not previously ascertained in up to 125 urine specimens obtained from normal women and from women with gestational hypertension within seven days of documented hypertension; and (3) measure the quantity of elemental calcium in each of up to 100 study medication tablets for purposes of quality control. The comparison of urinary excretion of calcium and related nutrients will be a nested case control study using stored urine specimens collected at specified times during pregnancy and at the diagnosis of preeclampsia from pregnant women participating in CPEP. CPEP is a randomized clinical trial designed to determine whether oral calcium supplementation will prevent preeclampsia. The Contractor will be expected to measure calcium, sodium, potassium, chloride, magnesium, zinc, phosphorus, urea nitrogen, and creatinine in approximately 5912 urine specimens selected by the Project Officer over the course of one year. Measurements of protein and creatinine in up to 125 additional urine specimens and calcium content of up to 100 study medication tablets must also be completed within the same year. INQUIRIES This announcement is a new solicitation. The issuance of this Request for Proposals (RFP) will be on or about March 6, 1995, and proposals are due by 4:00 p.m. (local time), May 2, 1995. The short-form version of the RFP will be provided first, which includes only the Statement of Work, Technical Reporting Requirements, Background Information, and the Evaluation Criteria to be used for selection of the awardee. After examining this, a full-text version of the RFP must be requested, in writing, for those organizations interested in responding. FAX requests are acceptable. All requests must cite the RFP number and include two self-addressed mailing labels. All sources who consider themselves qualified are encouraged to submit a proposal. This advertisement does not commit the Government to make an award. Organizations desiring a copy of the short-form RFP may send a written request to: Mrs. Lynn Salo Office of Grants and Contracts National Institute of Child Health and Human Development Executive Building, Room 7A07 6100 Executive Boulevard MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-4611 FAX: (301) 402-3676 $$R2 END ************************************************************ $$R3 BEGIN AI-95-012 FULL-TEXT ************************************** HEPATITIS C COOPERATIVE RESEARCH CENTERS NIH GUIDE, Volume 24, Number 8, March 3, 1995 RFA AVAILABLE: AI-95-012 P.T. 34; K.W. 0715125, 1002045, 0765033, 0710030 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 7, 1995 Application Receipt Date: July 18, 1995 PURPOSE Applications are invited for Hepatitis C Cooperative Research Centers (HC CRCs) to perform innovative, systematic, collaborative basic and clinical research on hepatitis C virus (HCV). Using integrated approaches from multiple disciplines, the HC CRCs will serve as foci for generating the knowledge needed to further understanding of HCV infection, recovery, and pathogenesis. Building on this knowledge, HC CRCs will devise original preventive and therapeutic interventions. HEALTHY PEOPLE 2000 The Public Health Service (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. This Request For Applications (RFA), Hepatitis C Cooperative Research Centers (HC CRCs), is related to the priority area of immunization and infectious diseases. 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 202-783-3238). INQUIRIES This RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this program, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov), and by mail and email from the program contact listed below. Dr. Leslye Johnson Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard - MSC 7630 Solar Building, Room 3A-22 Bethesda, MD 20892-7630 Telephone: (301) 496-7051 Email: lj7m@nih.gov $$R3 END ************************************************************ From owner-sci-resources@net.bio.net Fri Mar 03 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-95-012 - V24(08) 03/03/95 Date: 3 Mar 1995 16:47:29 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 717 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3j8db1$3gn@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI95012 AI-95-012 P1O1 *************************************** HEPATITIS C COOPERATIVE RESEARCH CENTERS NIH GUIDE, Volume 24, Number 8, March 3, 1995 RFA: AI-95-012 P.T. 34; K.W. 0715125, 1002045, 0765033, 0710030 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: April 7, 1995 Application Receipt Date: July 18, 1995 PURPOSE The Enteric Diseases Branch of the Division of Microbiology and Infectious Diseases (DMID) of the National Institute of Allergy and Infectious Diseases (NIAID) invites applications for the establishment of high-quality Hepatitis C Cooperative Research Centers (HC CRCs). The purpose of this Request for Applications (RFA) is to stimulate multidisciplinary, multi-project, collaborative research on hepatitis C virus (HCV). Such clinical and basic research will further the understanding of early and mid, rather than late (liver failure or liver cancer), stages and manifestations of hepatitis C infection, disease, and recovery. The HC CRCs will build on new findings to develop vaccine and therapy strategies. HEALTHY PEOPLE 2000 The Public Health Service (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. This RFA, Hepatitis C Cooperative Research Centers (HC CRCs), is related to the priority area of immunization and infectious diseases. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic non-profit and for-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply but may be part of a collaborative arrangement as described under STUDY POPULATIONS. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Multi-component Cooperative Agreement (U19), an "assistance" mechanism, rather than an "acquisition" mechanism. The U19 must have a minimum of three inter-related research projects around a common theme as well as collaborative efforts and interactions among component investigator-initiated projects and their investigators to achieve a common goal. Further information can be found in NIAID's "Application Guidelines for Multiproject Research Awards, November 1994," which are available from the individuals listed under INQUIRIES. The Multi-component Cooperative Agreement differs from the Program Project in that the U19 anticipates substantial NIH scientific and/or programmatic involvement with the awardee during performance of the activity. Under the cooperative agreement, the NIH's 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. However, NIH is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the study funded under agreement(s) are discussed later in this document under the section Terms and Conditions of Award. HC CRCs may involve collaboration among investigators at several institutions. These consortium arrangements should follow the NIH "Guidelines for Establishing and Operating Consortium Grants, January 1989." These are available from the individuals listed under INQUIRIES. The total requested period for applications submitted in response to this RFA may not exceed five years. At present, the NIAID is administratively limiting the duration of U19 agreements to four years; this administrative limitation may change in the future. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond the present RFA. The earliest anticipated award date is May 1, 1996. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $1.5 million. In Fiscal Year 1996, the NIAID plans to fund two or three HC CRCs. The final number of awards to be made is dependent upon the availability of funds. The initial year's total costs, including direct and indirect costs, should not exceed $750,000 for each award. The usual PHS policies governing grants administration and management will apply. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the agreement upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background Hepatitis due to hepatitis C virus (HCV) is classified as an emerging infectious disease (IOM Report, 1992). Just six years ago, investigators identified HCV as an important etiological agent of non-A, non-B hepatitis and chronic liver disease through cloning and sequencing efforts. HCV infects close to 200,000 individuals each year in the U.S., affecting Hispanics and Afro-Americans disproportionately. The modes of transmission remain unidentified for an alarming 43 percent of cases. Recovery from infection is rare and at least 70 percent and quite possibly 90 percent of those infected become chronic carriers. Thus, 140,000 - 180,000 U.S. citizens become new chronic carriers each year. Even when the initial infection is asymptomatic, as it is in a high percentage of people, severe chronic liver disease with its concomitant high morbidity and mortality occurs. The CDC estimates that one to two percent of the people in the U.S., i.e., 2.5-5.0 million individuals, are chronically infected with HCV. The same one to two percent carrier rate is true around the world with the exception of a few high endemicity areas such as some inner city areas in the U.S., Egypt, the Sudan, and isolated villages in Asia. In the U.S. the total cost for HCV infection and chronic sequelae is estimated at $1.5 billion per year. Since identification of HCV considerable progress has been made. Molecular biological techniques have enabled investigators to: (1) clone and sequence many genotypes; (2) map the HCV genome and identify some of its functions; and (3) analyze structural and nonstructural proteins and the processes by which they are made. New diagnostics have been instrumental in: (1) verifying the agent causing liver disease in symptomatic patients as well as identifying asymptomatic patients; (2) preventing transmission in transfusion, transplantation and hemodialysis patients; and (3) identifying cofactors for infection and chronic disease. There have been efforts to define modes of transmission as well as affected and at risk population groups. Studies of (immuno)pathogenesis and viral replication are beginning. Despite these advances, infection and disease caused by HCV remain enigmatic, and prevention and treatment problematic. Mechanisms of liver disease and the host's role in viral persistence are largely unexplored. Significant gaps exist in the knowledge base regarding HCV's natural history and progression of disease. An obstacle to vaccine development stems from the inadequate immune response to natural infection -- viral clearance is exceedingly rare even though neutralizing antibodies have recently been detected. The large number of HCV genotypes and their high rate of mutation as well as the existence of genetic variants, i.e., "quasispecies," pose obstacles both to prevention and treatment. Alpha interferon, the only available therapy, is less than adequate and has associated toxicity. Additionally, sample sizes in human studies have often been inadequate to draw statistically significant conclusions. HCV indeed poses tough challenges for scientists and clinicians. Prevention of infection, e.g., through vaccination, and cure or amelioration of disease have the greatest promise for those at risk and affected respectively. For diseases like hepatitis B they have been shown to be highly cost-effective. Thus in this RFA, the NIAID is interested in research focused on acute and chronic disease rather than on liver failure or cancer. Objectives and Scope This RFA seeks to support state-of-the-art, innovative research on hepatitis C virus. Using integrated approaches from multiple disciplines, the HC CRCs will serve as foci for generating the knowledge needed to further understanding of HCV infection, recovery, and pathogenesis. And building on this knowledge, to devise original preventive and therapeutic interventions. The NIAID expects clinical issues and needs to be the driving forces for research performed by the HC CRCs. Relevant topics for research may include but are not limited to: o identify host responses to infection, e.g., correlates of immunity associated with prevention of infection and disease as well as recovery from acute and chronic infection; o explore host mechanisms involved in fostering and maintaining viral persistence; o identify mechanisms of pathogenesis which lead to and exacerbate liver disease; o develop small animal model and in vitro systems which are relevant for HCV vaccine, antiviral, and pathogenesis research; o develop infectious cDNA clones and utilize them in ways directly relevant to disease research; and o assess the impact of viral heterogeneity, e.g., genotypes and "quasispecies", on disease initiation and progression, the development of protective immunity, treatment outcome, etc.; o utilize findings to bridge the gaps between basic, applied, and clinical research by developing and evaluating intervention strategies, e.g., broaden or enhance protective immunity, subvert avoidance mechanisms. SPECIAL REQUIREMENTS Relevant Disciplines To foster multidisciplinary research, each HC CRC should include approaches from at least four disciplines such as virology, immunology, pathogenesis, the liver (cells, tissue, and organ) and changes (biology, biochemistry, etc.) in response to infection, clinical infection and disease, model system development, and applied research. HC CRC Collaborative Studies During the award period collaborative studies among HC CRCs may enhance research progress and increase the significance of HC CRC contributions. Examples include, but are not limited to, rapid accrual of patients or augmented access to samples. Hence, applicants should be willing to share samples as well as to participate in multicenter activities and common protocols. These will be encouraged and stimulated by the Scientific Coordinator through discussions with the Program Directors and at meetings and workshops scheduled as part of these awards. Steering Committee Meetings and Workshops To coordinate activities, facilitate interchanges, and develop collaborative opportunities, HC CRC Program Directors and the NIAID Scientific Coordinator will meet twice a year as a Steering committee. To enhance information exchange, Project Leaders will be expected to attend workshops in Years 1 and 3 of the award period. Clinical Capability To move forward with basic and clinical approaches, HC CRCs must have access to, and clinical experience with, well-characterized and diverse patient samples and populations representing different disease stages. The value of research and studies performed will be directly related to the care exercised in selection and characterization of cases and controls. Programs should include participation of human subjects to address research questions. NIAID encourages: (1) collaborative arrangements with ongoing studies or clinical care capable of providing patient populations, specimens and information; (2) applicants from institutions that have a General Clinical Research Centers (GCRC) funded by the NIH National Center for Research Resources to identify the GCRC as a resource for conducting the proposed research. In both cases letters of collaboration or agreement from the study's principal investigator and/or GCRC program director should be included in the application material. Access to and experience with patient populations also will be helpful should progress warrant studies with promising new vaccine and therapy candidates. In describing the clinical and laboratory facilities, the applicant should include specific information on present patient load, projections for patient involvement in future clinical investigations, history of recruitment and study of subjects, and disease category and prevalence as well as the availability of appropriate biohazard facilities and safety procedures. Budget and Related Issues Applications should budget appropriate funds to allow the Program Director of each HC CRC (also known as the HC CRC Director) to attend meetings in Bethesda, MD with the NIAID Scientific Coordinator twice each year and for all HC CRC Project Leaders to attend HC CRC workshops twice during the program period. Applicants should be aware that no additional travel monies will be awarded. Funds for travel to HC CRC meetings must be included in applicant's budget. (See below: SPECIAL REQUIREMENTS, Terms and Conditions of Award, 3. Collaborative Responsibilities.). Optional Developmental Fund for Pilot Studies Applicants may include a request for a Developmental Fund of up to $60,000 in direct costs to provide support for pilot projects. Such pilot projects might develop methods or resources capable of enhancing basic and clinical research progress, follow-up on new observations and hypotheses, or perform short term high risk - high benefit research. They should fit within the relevant disciplines listed above. It is envisioned that availability of funds for pilot studies will increase flexibility and responsiveness to important new scientific observations and medical reports and encourage the development of research investigators interested in hepatitis C. Pilot studies need not be restricted to the awardee institution. IT IS EMPHASIZED THAT PILOT STUDIES AWARDED FROM THE DEVELOPMENTAL FUND ARE DISTINCT FROM INDIVIDUAL HC CRC RESEARCH PROJECTS. Direct costs may not exceed $20,000 for any single pilot study and supplies and equipment expenditures may not exceed $7,000 annually per study. The duration of support for each study typically would be one year, but may be up to two years. In the event the study is independently funded through a traditional research project grant (R01) or a FIRST (R29) award prior to the end of the award period, the support of the pilot study from the Developmental Fund must be terminated, and unexpended funds must be returned to the Developmental Fund. Funds reserved for pilot projects may not be rebudgeted into other budget categories except in unusual circumstances and following approval from the Awarding Unit and the Scientific Coordinator. The HC CRC must maintain detailed records of disbursements and expenditures of the Developmental Fund. Potential awardees and specific research projects to be pursued need not be identified in the application. However, the application should include a one page description of the kind of project that might be funded under this mechanism and how it interdigitates with other CRC projects. Approval of the developmental funds portion of the application does not in any way commit the program directors to the execution of the sample project. It is anticipated that prior to the HC CRC Program Director proposing pilot studies to the NIAID Scientific Coordinator, these studies and their budgets will be reviewed and recommended by a local review committee. The application must provide a description of the review process and selection criterion for proposed projects. Examples of criteria are scientific merit of the proposal, medical relevance and need for data to advance the research objectives of the HC CRC. It is recommended that no one applying for a development pilot project be on the review committee. Studies involving Human Subjects will require prior approval by the Institutional Review Board like all other NIH supported projects. The $30,000 annual direct costs should be entered in the OTHER category in the Consolidated Budget (see pages 12 and 19 in the accompanying brochure). Terms and Conditions of Award The following terms and conditions will be incorporated into the award notice. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the agreement, the NIH's 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. Awards will be made to an institution on behalf of a Program Director who will be responsible for the coordination of HC CRC scientific and administrative activities. Support of all HC CRC activities will be coordinated through a Central Operations Office located within the applicant organization. 1. Awardee Rights and Responsibilities Awardees will have primary responsibility for defining the details for the project within the guidelines of the RFA and for performing the scientific activity, and agree to accept close coordination, cooperation, and participation of NIAID staff in those aspects of scientific and technical management of the project as stated below under NIAID Staff Responsibilities. Specifically, awardees have primary responsibilities as described below. Under the Cooperative Agreement, a partnership relationship exists between the recipient of the award and NIAID in which successful applicants are responsive to the guidelines and conditions set forth in the RFA. At the same time, investigators are expected to define research objectives and approaches in accord with their own interests and perceptions of novel and exploitable approaches to the research which ultimately is likely to result in improved prevention and control of hepatitis C. It is the primary responsibility of the HC CRC Program Director to clearly state the objectives and approaches of the research, to plan and conduct the research stipulated in the application, and to ensure that the results obtained are analyzed and published in a timely manner. The HC CRC Program Director also will propose pilot studies to the NIAID Scientific Coordinator after review of these studies and their budgets by a local review committee. NIAID may periodically review and generate internal reports from data and progress reports developed under this agreement. The data obtained will, however, be the property of the awardee. 2. NIAID Staff Responsibilities The NIAID will have substantial scientific/programmatic involvement during the conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The NIAID will work closely with the Program Directors and shall be represented by the Scientific Coordinator (Program Officer). The Scientific Coordinator will be the Hepatitis Program Officer in the Enteric Diseases Branch of NIAID. During the award period, the NIAID Scientific Coordinator may provide appropriate assistance, advice, and guidance in: o overall design of studies, e.g., prospective or intervention, especially those undertaken jointly by the HC CRCs; o linkage to special populations and vaccine production facilities funded through NIAID contracts, NIAID's data collection and analysis contracts, and DMID staff capabilities with respect to IND filing; o coordination and facilitation of information, technology, reagent and pedigree specimen exchange between HC CRCs themselves and with other grantees; o assistance in review and selection of developmental fund awardees; and o technical and administrative activities of HC CRCs. However, it is again emphasized that the role of NIAID will be TO FACILITATE AND NOT TO DIRECT THE ACTIVITIES of the HC CRCs. It is anticipated that decisions in all activities outlined within this RFA will be reached by consensus of the investigators and that the NIAID Scientific Coordinator will be given the opportunity to offer input to this process. In the event that research supported by the Cooperative Agreement results in development of a therapeutic or other medical intervention, NIAID will retain the option to cross-file or independently file an application for investigational clinical trial (i.e., an Investigational New Drug Application [INDA]) to the United States Food and Drug Administration. To facilitate this, reports of data generated by the HC CRC or any of its members which are required for inclusion in INDs and Clinical Brochures and for cross-filing purposes will be submitted by the Program Director to the Scientific Coordinator upon request. Such reports will be in final draft form and include background information, methods, results, and conclusion. They will be subject to approval and revision by NIAID and may be augmented with test results from other Government sponsored projects prior to submission to the appropriate regulatory agency. 3. Collaborative Responsibilities The HC CRC Program Directors and NIAID Scientific Coordinator will form a Joint Steering Committee which will meet at the NIH in Bethesda, Maryland (or at a site designated by NIAID) twice a year. Its functions include, but are not limited to: tracking and reviewing activities/progress over the six months between meetings, planning for the next six months and beyond, maintaining focus, and developing collaborative efforts among HC CRCs. The Program Directors and Scientific Coordinator will have voting rights. Issues for discussion and agendas will be a collaborative responsibility. The first steering committee meeting will occur shortly Post Award. Twice during the project period and in conjunction with the semi-annual Steering Committee meeting, workshops for the Program Directors and Project Leaders will be convened to share hepatitis C research advances, to discuss research needs and opportunities, and to develop collaborations. It is likely that these workshops will be convened in Year 1 and Year 3 of the project period at the NIH in Bethesda, Maryland (or at a site designated by NIAID). 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients and the NIAID may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Program Director, a second member selected by the NIAID, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR part 50, subpart D, and HHS regulation at 45 CFR part 16. STUDY POPULATIONS A strong emphasis is placed on studying hepatitis C in racial/ethnic populations that are disproportionately affected. These populations include African-Americans and Hispanics. Subjects may be recruited or specimens obtained from domestic sites or through collaborations with foreign institutions if the collaboration is beneficial to the foreign country and offers the potential for collection of hepatitis C data that are pertinent to U.S. populations and could not be generated as effectively in the United States. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from Dr. Johnson at the address listed under INQUIRIES. Dr. Johnson may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 1, 1995, a letter of intent that includes a descriptive title of the overall proposed research, the name, address, and telephone number of the Program Director, a list of the key investigators and their institution(s), and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Olivia Preble at the address listed under INQUIRIES. APPLICATION PROCEDURES It is highly recommended that potential applicants contract Dr. Leslye Johnson in the early stages of application preparation. Before preparing an application, the applicant should carefully read the information brochure, "NIAID APPLICATION GUIDELINES FOR MULTIPROJECT RESEARCH AWARDS," available from the contacts listed under INQUIRIES. Instructions for formatting the application as outlined in the brochure should be followed carefully. Failure to follow the instructions may result in unnecessary delays in the review process. Applications are to be submitted on the standard research grant application form PHS 398 (rev. 9/91). These application forms may be obtained from the institution's office of sponsored research or its equivalent and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label 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 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, in one package, to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (express mail) At the time of submission, two additional exact copies of the grant application and all five sets of appendix material must also be sent to: Dr. Olivia Preble Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-20 MSC 7610 6003 Executive Boulevard Bethesda, MD 20892-7610 Rockville, MD 20852 (express mail) Applications must be received by July 18, 1995. All components, subparts and sections of the application must be collated into the application, and the packages sent to the DRG and to the NIAID must each be complete in themselves. Applications that do not conform to the instructions contained in PHS 398 (rev. 9/91) application kit will be judged nonresponsive and will be returned to the applicant. Current NIH policy permits a component research project of a multiproject grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multiproject application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multiproject grant. This is an NIH policy intended to preserve the scientific integrity of a multiproject grant, which may be seriously compromised if a strong component project(s) is removed >From the program. Investigators wishing to participate in a multiproject grant must be aware of this policy before making a commitment to the Program Director and awarding institution. REVIEW CONSIDERATIONS Review Method Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) for completeness and for responsiveness by NIAID staff. Incomplete and non-responsive applications will be returned to the applicant without further consideration or review. Those applications that are complete and responsive may be subjected to a triage by a peer review group to determine their scientific merit relative to other applications received in response to this RFA. The NIAID will remove from competition those applications judged to be non-competitive for award and will notify the Program Directors and institutional business officials. Those applications judged by the reviewers to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The standard review criteria are stated in the NIAID GUIDELINES FOR MULTIPROJECT RESEARCH AWARDS, which is available from the program staff listed under INQUIRIES. In addition, the following criteria will apply: o the scientific and technical significance, merit, and originality of the research projects and anticipated contributions to the understanding of HCV's immunology and disease; o the scientific expertise and experience of the Program Director, the Project Leaders and key project and core personnel; o documentation of a strong clinical capability, adequate and appropriate patient populations, disease prevalence, and historical success of recruitment and retention of subjects; o documentation of the sponsoring institution's commitment to the program and willingness to accept the participation and assistance of NIAID staff; o adequacy of proposed plan for coordination and communication within the applicant HC CRC and with NIAID and other HC CRCs; and o adequacy of proposed plan for selection of pilot studies. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program balance, and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Leslye Johnson Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Solar Building, Room 3A-22 MSC 7630 6003 Executive Boulevard Bethesda, MD 20892-7630 Telephone: (301) 496-7051 Email: lj7m@nih.gov Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Dr. Olivia Preble Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C-20 MSC 7610 6003 Executive Boulevard Bethesda, MD 20892-7610 Rockville, MD 20852 Telephone: (301) 496-8208 Email: op2t@nih.gov Direct inquiries regarding fiscal matters to: Linda M. Shaw Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B-33 MSC 7610 6003 Executive Boulevard Bethesda, MD 20892-7610 Rockville, MD 20852 Telephone: (301) 496-7075 Email: lsl5k@nih.gov Schedule Letter of Intent Receipt Date: April 7, 1995 Application Receipt Date: July 18, 1995 Scientific Review Date: November 1995 Advisory Council Date: January 1996 Earliest Award Date: May 1, 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.855 Immunology, Allergic and Immunological Diseases Research and 93.856 Microbiology and Infectious Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of the Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Mon Mar 06 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 5 March 1995 Date: 6 Mar 1995 17:21:32 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 160 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3jgces$pdh@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system in the previous week. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Letter Title: LMPS01 - Dear Colleague Letter File size (bytes): STIS Filename: lmps01.txt Document Type: Press Release Title: DIAL-A-SCIENTIST STUDYING EL NINO File size (bytes): STIS Filename: pr9514.txt Title: NSF-FUNDED RESEARCH WILL HELP NATURAL GAS INDUSTRY File size (bytes): STIS Filename: pr9515.txt Title: COMPUTATIONAL SCIENCE HIGHLIGHTS AVAIBABLE ON WORLD WIDE WEB File size (bytes): STIS Filename: pr9516.txt Document Type: Program Guideline Title: NSF 95-37 - Multi-User Biological Equipment and Instrumentation Resources Instrument Development for Biological Research File size (bytes): STIS Filename: nsf9537.txt Title: NSF 5-40 Program Description for Bioengineering and Environmental Systems File size (bytes): 27276 STIS Filename: nsf9540.txt Title: NSF 95-44 An Opportunity in the Environment and Global Change Research Initiative File size (bytes): STIS Filename: nsf9544.txt Title: NSF 95-44 An Opportunity in the Environment and Global Change Research Initiative File size (bytes): STIS Filename: nsf9544.txt Title: NSF 95-45 The National Science Foundation Global Change Research Program a component of the U.S. Global Change Research Program File size (bytes): STIS Filename: nsf9545.txt Title: NSF 95-47 NSF/DOE/NASA/USDA JOINT PROGRAM ON TERRESTRIAL ECOLOGY AND GLOBAL CHANGE File size (bytes): STIS Filename: nsf9547.txt Title: NSF 95-49 -- ENVIRONMENTAL GEOCHEMISTRY AND BIOGEOCHEMISTRY Research at the Interfaces of Geochemistry, Hydrology, Coastal Sciences, Chemistry, Microbial and Molecular Biology, Colloid and Transport Engineering, and Mathematics File size (bytes): STIS Filename: nsf9549.txt Title: NSF 95-52 -- CIVIL INFRASTRUCTURE SYSTEMS File size (bytes): STIS Filename: nsf9552.txt Title: NSF 95-54 -- NATIONAL CONSORTIUM FOR RESEARCH ON VIOLENCE File size (bytes): STIS Filename: nsf9554.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 10955 STIS Filename: cmmtg.txt Document Type: Phone Book Title: NSF Alpha Telephone File size (bytes): 97256 STIS Filename: phnalpha.txt Title: NSF Alpha Telephone File size (bytes): 97256 STIS Filename: phnalpha.txt Title: NSF Organizational Directory File size (bytes): 98642 STIS Filename: phnorg.txt Title: NSF Organizational Directory File size (bytes): 98642 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 5-40 Program Description for Bioengineering and Environmental Systems File size (bytes): 27276 STIS Filename: nsf9540.txt Document Type: Recruit Title: Senior Executive Service Nationwide Vacancy Listing File size (bytes): 31653 STIS Filename: sesvac.txt Title: Student Career Experience Program (SCEP) File size (bytes): 5255 STIS Filename: vgs9566.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS The above files can be retrieved in electronic form using the STIS system. If you don't know how to use STIS, send an E-mail message to stisinfo@nsf.gov (Internet). You will receive a copy of the STIS flyer via E-mail. If you are already using STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov (Internet). Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vgs9566.txt, the text of your message should be as follows: get vgs9566.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vgs9566.txt, you would enter: ftp> get vgs9566.txt WAIS or Gopher: Do a word search on the filename as shown in the summary. If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov" (Internet). If you have problems with the above procedures: Send a message to "stis@nsf.gov" (Internet). From owner-sci-resources@net.bio.net Tue Mar 07 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HS-95-003 - V24(09) 03/10/95 Date: 8 Mar 1995 15:07:48 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 966 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3jldc4$q0f@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HS95003 HS-95-003 P1O1 *************************************** CONSUMER ASSESSMENTS OF HEALTH PLANS STUDY NIH Guide, Volume 24, Number 9, March 10, 1995 RFA: HS-95-003 P.T. 34; K.W. 0404021, 0755018, 0730000 Agency for Health Care Policy and Research Letter of Intent Receipt Date: May 20, 1995 Application Receipt Date: June 20, 1995 PURPOSE The Agency for Health Care Policy and Research (AHCPR) invites applications for cooperative agreements to: (1) produce reliable, valid and rigorously tested survey protocols for collecting information from consumers regarding their assessments of health plans and services; (2) develop and test the effectiveness of different formats for conveying resulting information to consumers; (3) demonstrate the resulting survey protocols in real world settings; and (4) evaluate the usefulness of this information in assisting consumers, and purchasers acting on their behalf, in making informed selections of health care plans and services. The long term goal of this project is to strengthen the science base underlying the evolution and the use of consumer surveys within the health care industry. HEALTHY PEOPLE 2000 The Public Health Service (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. This RFA, Consumer Assessments of Health Plans Study (CAHPS), is related to the priority areas of access to and use of clinical preventive services, maternal and child health services, and health services related to major disease categories. 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by public and private non-profit private domestic organizations or associations, including universities, units of State and local governments, non-profit firms and foundations; or a consortium of organizations. If the application is submitted by a domestic, non-profit, public or private organization, a consortium may include other types of organizations, such as for-profits. Racial/ethnic minorities, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The administrative and funding instrument will be the cooperative agreement (U18), an "assistance" mechanism in which substantial AHCPR scientific and programmatic involvement with the awardee(s) is anticipated during the performance of the project. The total project period for each application submitted in response to this RFA may not exceed five years. The anticipated award date is September 30, 1995. Funding beyond the initial budget period will depend upon annual progress reviews by AHCPR and the availability of funds. FUNDS AVAILABLE The AHCPR expects to award up to $2 million for two projects not to exceed $1 million in total costs for each project for the first year. The number of awards is dependent on the number of high quality applications responding to this RFA. This is a one time solicitation. RESEARCH OBJECTIVES Background Public and private organizations are surveying consumers to collect information on access to care, use of health services, health outcomes, and patient satisfaction. The results of these surveys are being used by: consumers to inform their choices about health care plans; purchasers to assess the value of the services they buy; and health insurers, quality assurance managers and policy makers, to plan programs and services. Existing tools for obtaining information from health plan enrollees vary on several dimensions: content of the questions; characteristics of intended respondents; and fit to particular health care settings. The extent to which these instruments have been tested and the methods used to accomplish the testing also differ across surveys. Because of these variations, it is unlikely that any single existing instrument will produce accurate and useful assessments from (and for) consumers across different types of plans and health care settings. Potential survey users require responses to a range of critical questions including, but not limited to, the following: Are existing instruments capable of producing reliable and valid assessments of consumer evaluations of health care services? Do they include the full range of topics important to consumers? Can they be used to obtain information from the full range of audiences of interest, including high users of health care services; people insured under managed care as well as fee-for service plans; consumers with poor literacy skills; plan disenrollees; participants in publicly subsidized programs; and relatively healthy middle-class health care consumers? Even if reliability and validity can be demonstrated, will potential users, particularly inexperienced ones, know how to conduct a valid survey? Will different users collect data in a manner that allows valid comparison across a variety of health plans? And most importantly, if these efforts can be accomplished, will they yield the expected pay-off; that is, the production of accurate, understandable information that enables consumers and purchasers acting on their behalf to identify and select appropriate, high-quality health care coverage? In September 1994, AHCPR co-sponsored a conference with the Robert Wood Johnson (RWJ) Foundation, "Consumer Survey Information in a Reformed Health Care System." Conference papers and discussions identified no single instrument that could be used across a wide variety of consumer groups and within multiple service settings to obtain assessments of health plans and services. Some of these surveys are effective, though, for a specific purpose, population or service. Thus, these various instruments offer the possibility of constructing "question modules" -- sets of questions drawn from a variety of sources and relating to diverse concepts, consumers and delivery settings -- to use as the basis for activities to be performed under this agreement. The AHCPR is currently supporting a project with that goal: to construct question modules from existing survey instruments. This Survey Design Project, through contract to the Research Triangle Institute, is developing modules of consumer survey questions. These modules ask about the experiences of consumers regarding access to care, use of specific health services, health outcomes, and satisfaction with the care received. The goal of the project is to produce modules that are adaptable to a variety of health care settings. The Survey Design Project began with an extensive search for question modules and items. This search was guided by recent published and unpublished studies on consumer information needs. The contractor then developed an Adult Health Care Survey and began developing modules and items related to other areas of interest. Although validity and reliability studies were not within the scope of work, items in the modules were subjected to rigorous cognitive testing to ensure appropriate interpretation by respondents. Items in the modules were then revised as necessary to be understandable to consumers who receive care through different benefits arrangements (e.g., fee for service as well as managed care plans). Finally, this project's methods and products were reviewed by as many interested parties as could be identified. This review included two public meetings, one held at the beginning of the contract and one at the end. Draft modules and materials were circulated for comments to over 100 researchers, consumers and potential users. The project was also informed by a technical panel of researchers and representatives of health insurance organizations, managed care organizations, clinical associations and other groups. Because AHCPR wishes to provide rapid access to products from the Survey Design Project and to products resulting from CAHPS, we plan to disseminate both through the AHCPR User Group Initiative. This effort is being developed to respond to requests from potential users who wish to begin using consumer question modules as early as possible, even before the completion of the systematic demonstration called for in this RFA. Points at which grantees are expected to coordinate activities with the User Group Initiative are noted under RESEARCH OBJECTIVES, Study Design. The results of the Survey Design Project, including limited technical and operational instructions, will be placed in the public domain no later than March 30, 1995. The results of the Survey Design Project, the AHCPR/RWJ conference and other relevant efforts are being made available to potential applicants and others (see INQUIRIES). Objectives and Scope The objectives of this RFA are to: (1) produce reliable, valid and rigorously tested survey protocols for collecting information from consumers regarding their assessments of health plans and services; (2) develop and test the effectiveness of different formats for conveying resulting information to consumers; (3) demonstrate the resulting survey protocols in real world settings; and (4) evaluate the usefulness of this information in assisting consumers, and purchasers acting on their behalf, in making informed selections of health care plans and services. To save time and resources, applicants should select the best existing set of questions currently in the public domain and use it to accomplish objectives 1 and 2. For purposes of this RFA, the "best existing set of questions" is that which most successfully addresses the following questions and concerns: 1. Who are the critical consumers from whom to collect assessments of health care plans and services? Successful applicants will develop and test a core question module designed to obtain a basic assessment of plan features and services from relatively healthy, adult, middle-level socioeconomic status (SES) Americans who receive care through the predominant types of benefits plans and delivery settings (e.g., indemnity plans, managed care plans, etc). Grantees should develop and test additional modules, as time and budget permit, to obtain assessment data from some of the following types of consumers: a. Parents of young children, especially those of low SES, b. Racial and ethnic minorities, c. Participants in publicly subsidized health programs, such as Medicaid or State health programs, d. High users of health care services, such as the chronically ill, those suffering severe acute episodes of illness, and persons with disabilities, e. Persons living in rural areas, f. Persons with poor literacy skills, and g. Disenrollees from health plans. For which of these potentially important consumer groups should question modules be developed? After the core module is completed, what should be the sequence of module development? What rationale supports this prioritization? Applicants should address these questions as part of their application. If applicants discover that items or question modules for use with a consumer group perceived as high- priority do not exist, they should propose development of those modules as part of this project. 2. What information on access and quality do consumers want and need to assist in selecting health care plans and services? How do information needs vary by type of audience? Although a large-scale, fully developed needs assessment covering the entire range of topics and consumers may not exist, a number of qualitative (e.g., focus group studies by AHCPR and the National Committee on Quality Assurance in 1994) and quantitative (e.g., a survey by Consumers Union 1995) studies conducted recently provide information related to this question. If an applicant discovers an access or quality-related information need for which items/questions modules do not exist, the applicant may propose development of those modules as part of this project. 3. Through what types of benefits arrangements and delivery settings are the consumer groups of interest likely to receive services? Consumers may conceivably obtain health care services through fee for service plans, diverse types of managed care plans, public assistance programs or other types of benefits arrangements. These benefits may be offered through public or private employers, purchasing cooperatives, multi-state health plans, or public health clinics. This diversity of benefits and settings means that items, or the wording of items, from any given set of questions may not be appropriate for all consumers in all situations. In selecting their core questions module, applicants should consider that the overall goal of CAHPS is to produce modules (especially a core module) that will allow comparability across the greatest possible range of plans and benefits arrangements. Since it is unlikely that any existing module was designed with application to multiple settings in mind, applicants should discuss in their application the extent to which their selected module will require post-award testing to meet this goal. 4. What evidence exists to ensure that consumers interpret proposed survey items as the developers intended? As mentioned under RESEARCH OBJECTIVES, Background, a variety of instruments exist with which to obtain consumer perceptions about health care services. A limitation of some of these instruments is their lack of cognitive testing of survey items with members of the target audience. In selecting question modules for use in this RFA, applicants should obtain information about the extent to which item interpretation was tested and the methods used to accomplish this. Because the AHCPR wishes to build on existing work to the greatest extent possible and to accomplish objectives 1 and 2 rapidly, it is recommended that the results of the Survey Design Project form the basis for activities to be performed under this agreement. The modules developed in the Survey Design Project, to AHCPR's awareness, best satisfy the concerns discussed above. Although use of the modules from the Survey Design Project is recommended, itis anticipated that applicants may make revisions, additions, or other alterations to them. Changes or alternatives to the modules are acceptable and appropriate to the extent that they address the concerns discussed above. In any case, each applicant must: (a) specify instruments or question modules and (b) discuss their suitability for accomplishment of study objectives. Applicants' responses to the four preceding questions should form the basis for Phase 1 of this project as described in the next section. Study design Grantees will need to accomplish a number of objectives in two phases, a project planning phase (Phase 1) and a demonstration and evaluation phase (Phase 2). During both phases, grantees will collaborate with the AHCPR project officer (and the advisory committee, when appropriate) to define and respond to key questions and issues that will guide the development of CAHPS products. Grantees are expected to prepare interim reports and a final report that summarizes all Phase 1 and 2 activities. Elements of these reports will be determined jointly by the grantees and AHCPR. Phase 1: Project planning The major goals of Phase 1 include: (a) development and initial implementation of a project work plan, (b) production of survey protocols suitable for use in real-world settings, (c) development and testing of report formats for survey information, (d) development and initial implementation of a process and outcome evaluation plan, and (e) recruitment of demonstration sites and development of a demonstration time table. Phase 1 is expected to be completed within 15 months of the award date. Applicants should provide information that demonstrates their ability to accomplish the activities listed below. Applicants may include in appendices descriptions of prior projects that demonstrate their experience in performance of similar activities. 1. Develop a work plan. This should include specification of project activities, linked to a listing of products and a time table for their execution or development. 2. Propose advisory committee (see SPECIAL REQUIREMENTS). Applicants should discuss proposed composition of the advisory committee (i.e., types of expertise required) and ways in which the advisory committee may be used most effectively during the course of the project. 3. Characterize focal consumer populations. Applicants will have laid the groundwork for this step as part of their application. In Phase 1, grantees and AHCPR (with input from the advisory committee) should complete specification of focal consumer groups, as well as determine their quality-related information needs. As they make these decisions, the project team should keep in mind that products resulting from CAHPS must be appropriate for use in a variety of settings as discussed in RESEARCH OBJECTIVES, Objectives and Scope, number 1. 4. Refine the question modules. Applicants will have selected existing modules and identified items/modules that need to be developed as part of the application. As the grantees develop new items and modules, they should make critical decisions jointly with AHCPR and with input from the advisory committee. 5. Perform all activities related to production of survey protocols that are ready for use in real world settings. This includes: testing the validity and reliability of question modules for each consumer group of interest; performing cognitive testing, as necessary, to ensure that respondents will interpret items as intended; resolving all issues related to sampling strategies; preparing alternative versions of survey instruments for administration by telephone or mail; developing and implementing plans for data analysis and processing, and other issues. As part of the application, applicants should identify criteria for site selection for Phase 1 reliability, validity and cognitive testing and obtain letters of commitment from actual sites. Because the user demand for rigorously tested survey modules is great, grantees are expected to perform reliability, validity and cognitive testing on a module-by-module schedule, with priority given to modules that have the widest applicability. As each module is tested and revised, it will be released to the public through the AHCPR User Group Initiative. Though many important activities need to be accomplished within the 15 month Phase 1 time frame, grantees should sequence activities so that the testing of questionnaire modules occurs as early as possible. 6. Coordinate activities as appropriate with AHCPR User Group Initiative. The purposes of the User Group Initiative are to disseminate modules and segments of the user manual as they are completed, track efforts at implementing the modules at sites other than those included in this cooperative agreement, and provide technical assistance to these users. 7. Develop/revise user manual. The user manual should provide thorough, comprehensive documentation to guide users, whether unsophisticated or highly experienced, through all activities associated with survey administration, including mail and telephone administration. 8. Develop and test sample reporting formats. Many different types of consumers will ultimately use reports based on data collected through these instruments. To be optimally useful to consumers, characteristics of the data-based reports should be tailored to fit characteristics of the intended user. On the other hand, some potential survey administrators will not have the resources required to develop reports specifically tailored to consumer subgroups. These users will need to know how to select appropriate formats from a stock of sample reports and how to design and test their own materials for a heterogeneous group of users. 9. Develop a process and outcome evaluation plan. One of the grantee's most important responsibilities under this agreement will be the development of a comprehensive plan to evaluate CAHPS products, procedures, and outcomes. This involves at least three components: (a) developing and implementing a plan for the evaluation of report formats; (b) developing and implementing a plan for the process evaluation of CAHPS procedures (e.g., the usefulness of the operations manual to staff at demonstration sites); and (c) developing and implementing a plan for the evaluation of the effectiveness of data-based reports to consumers. Though all of the evaluation planning must occur in Phase 1, the only evaluation data expected to be collected in Phase 1 is that related to step "a." Applications should demonstrate the applicant's ability to: o Specify appropriate evaluation questions, identify appropriate outcome measures and appropriate respondents for each question, and specify times at which these questions should be asked. o Develop an appropriate evaluation design. The design should: (a) eliminate as many threats to validity as possible; and (b) result in a clear demonstration of usefulness of the data-based reports in assisting consumer decision-making in an open enrollment situation, as well as identification of factors related to product effectiveness or ineffectiveness. o Identify and use appropriate qualitative and quantitative data collection instruments. o Analyze data appropriately. Applicants should pay particular attention to strategies for analysis of qualitative data, as well as the issue of conveying information from quantitative evaluation analyses in a manner that is understandable by and useful to personnel at sites implementing the survey protocols. o Develop recommendations based on evaluation data that can be used to modify CAHPS projects or procedures. One component of the CAHPS evaluation plan should be the development of clearly written, user-friendly recommendations designed to promote data-based changes to products and procedures. 10. Recruit sites and develop a time table for Phase 2 demonstrations. o Identify selection criteria for and propose demonstration sites. AHCPR is interested in a range of diverse demonstration sites as discussed above in RESEARCH OBJECTIVES, Objectives and Scope, numbers 1 and 3. Applicants are not required to include all of those types of settings in their applications, but should provide examples of the types of settings they intend to include, a rationale for their choice, and evidence of recent experience in undertaking large-scale, multi-site demonstrations. If necessary, AHCPR will work with the awardee to identify appropriate organizations. Final selection of sites will take place in consultation with the AHCPR Project Officer. o Identify key personnel from each potential site and specify their roles. Also, as sites are selected, grantees will need to identify appropriate demonstration site staff to be added to the advisory committee (e.g., the lead contact at each site, consumer representatives, etc.). o Building on the work plan discussed above, develop a demonstration time table. This document should contain all the information sites will need to know in order to commit themselves to the demonstration. Phase 2: Demonstration and evaluation The goals of Phase 2 are to: (a) work with demonstration sites to implement the tested survey protocols; (b) assess the effectiveness of data obtained through these surveys in assisting consumers with their health plan selections; (c) continue implementation of the process and outcome evaluation; and (d) revise CAHPS products and procedures based on evaluation data. Applicants should provide information which illustrates their ability to plan and implement large-scale, multi-site demonstrations, including their ability to accomplish the following activities. 11. Develop a demonstration management plan. After each site commits to the demonstration, the grantee should develop an overall management plan which will serve as the master plan to guide all demonstration activities. The groundwork for this plan will have been laid by development of demonstration time tables discussed at the end of Phase 1 activities. The management plan should clearly specify both grantee and site personnel roles and responsibilities and should include a time table listing key decisions related to and dates for all demonstration components. 12. Assist sites in all phases of demonstration activity as specified in the management plan, including: selecting appropriate survey modules; collecting data; using the operations manual; developing, testing, and disseminating reports in formats appropriate for the audiences of interest; and other activities. 13. Coordinate activity among all demonstration sites and work with the AHCPR User Group Initiative. 14. Collect process and outcome evaluation data at all appropriate points. The grantee should analyze evaluation data and produce reports which include recommended revisions to CAHPS products and procedures. 15. Revise products and procedures based on data-based recommendations. Before making these revisions, the grantee should consult with AHCPR and obtain input from the advisory committee. Timetable Phase 1 of CAHPS should be completed 15 months from the date of award. The entire project may take four to five years. SPECIAL REQUIREMENTS To promote the development of this multi-site collaborative project, a number of additional issues must be addressed in applications responding to this RFA, as discussed below. Budget Applicants must develop a timeline for project activities, including percentage of effort for key staff for all years, as part of the budget justification. Project Organization Applicants, or principal members of the consortium qualified to participate in this agreement, must have experience in: field survey operations; testing and improvement of survey instruments; management of multiple collaborators; program planning and evaluation; and development and evaluation of health-related materials for consumer audiences. If a consortium of institutions responds to this RFA, the application must describe a practical structure for consortium decision-making and governance, and the mechanisms designed to ensure that effective collaboration will occur among sites. Unanticipated disagreements about methods, resource allocation, standardization, authorship, etc., may arise during the course of any project. The consortium must be able to make unified decisions on the merits of these issues, without dissolving or routinely relying upon outside arbitration. Confidentiality of Data 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. Applicants must describe in the Human Subjects section number 5 procedures for ensuring the confidentiality of information. This should include a discussion of who will be permitted access to the information, both the raw data and machine readable files, and how personal identifiers will be safeguarded. Terms and Conditions of Award This cooperative agreement anticipates substantial AHCPR scientific and programmatic involvement with the awardees throughout the planning, implementation, and close-out of CAHPS. 1. Awardee Responsibilities The awardee will have primary and lead responsibility for all activities including: o Formation of the advisory committee, including convening meetings and documenting activities, with committee membership approved by the AHCPR project officer; o Development and implementation of a comprehensive process and outcome evaluation design; o Selection, in collaboration with the AHCPR project officer, of items or question modules from the consumer survey instrument that will be tested; o Identification and implementation of techniques to test the modules for reliability, validity, consistency in interpretation, and comparability across different sites/subpopulations; o Development and implementation of a module-by-module testing schedule; o Identification and recruitment of Phase 1 testing sites for reliability, validity, etc. Applicants should submit letters of commitment with the application; o Identification of characteristics of appropriate Phase 2 demonstration sites and selection, in collaboration with the project officer, of actual sites possessing these characteristics; o Development of sample selection strategy and identification of potential associated methodological issues; o Identification of methodological issues associated with administration of the survey to the subpopulations and sites of interest; o Identification of potential confidentiality concerns of test sites and individual respondents and a strategy for implementing safeguards that address these concerns; o Identification of methodological issues associated with mode of administration of the questionnaire; o Identification and implementation of procedures that enhance response rates; o Development and implementation, with project officer approval, of an appropriate data coding, preparation and analysis plan; o Development and documentation of strategies to address all outlined methodological issues; o Development, testing and revision of a comprehensive survey operations, or "user", manual suitable for use by organizations with minimal as well as extensive experience in fielding large-scale, multi-site surveys; o Provision of training and technical assistance to all Phase 2 demonstration sites; o Preparation and testing, in collaboration with project officer, of understandable, usable reports that summarize survey results and which are tailored to the subpopulations of interest; o Preparation of agreed-upon interim and final reports, including a summary report to inform AHCPR of any difficulties encountered in the course of planning, implementing and evaluating the surveys; o Provision of AHCPR access to all data generated under this award as it is collected; and o Cooperation with other key parties in this project, particularly the AHCPR User Group; other CAHPS grantees; and other complementary projects. 2. AHCPR Staff Responsibilities The AHCPR Project Officer and other AHCPR staff will have substantial scientific and programmatic involvement during the conduct of this activity, through technical assistance, advice, and coordination beyond the usual program stewardship for grants. Collaboration on the development of the testing plan, evaluation design and survey protocol will occur after the award is made. Specifically, AHCPR's role in the cooperative agreement is to provide technical assistance, advice, and support to the PI and to ensure that all related AHCPR-supported projects complement one another. AHCPR will: o Work with the grantee to structure composition of the advisory committee; o Approve composition of advisory committee, management plan and plans for data collection and analysis; o Participate in all key project decisions, including but not limited to: identification of focal consumer groups, assessment of consumer information needs, selection of items/question modules to be tested, identification and resolution of methodological issues; o Work with the grantee to identify and negotiate with Phase 2 demonstration sites, with the AHCPR project officer retaining right of final approval; o Establish collaboration with and obtain project-related information from other Federal agencies and programs; o Disseminate tested question modules and other research findings as they become available; and o Participate in or coordinate strategy sessions with the grantees on at least four occasions in the first year and up to every four months thereafter to review progress; The AHCPR will require prior written approval for the addition or deletion of a participating or collaborating institution, site, or other organizational component. The AHCPR reserves the right to terminate or curtail the study in the event of: o Insufficient progress towards completion of study goals within an agreed-upon time frame; o Inability to identify and recruit demonstration sites that include members of the subpopulations and settings of interest; o Inability to work collaboratively with demonstration sites, the advisory committee, or other necessary organizations; o Inability to successfully address key methodological issues; and o Substantive changes in the agreed-upon protocol with which the AHCPR does not agree. These special Terms of Award are in addition to and not in lieu of otherwise applicable PHS grants policies and Federal regulations. Collaborative Responsibilities As discussed under Phase 1 activities, grantees must establish an Advisory Committee to provide overall policy guidance and technical expertise, and assist in conflict resolution. The membership of the Advisory Committee may include, in addition to the Principal and Co-Investigators, the AHCPR project officer, consumers, methodology experts in the fields of health care consumer survey research, social marketing (with experience in developing health information for consumers), health insurance and other health-related research areas; representatives of public and private groups from Phase 2 demonstration sites, including employers, unions, health plan administrators, and other health insurance providers; and local and national health service providers and institutions. SPECIAL INSTRUCTIONS TO APPLICANTS CONCERNING INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the AHCPR that women and members of minority groups be included in all AHCPR supported research projects involving human subjects, unless 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. A new NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the AHCPR contractor, Global Exchange listed under INQUIRIES. AHCPR staff may also provide information concerning this policy. LETTER OF INTENT Prospective applicants are asked to submit, by May 20, 1995, a letter of intent that includes the name, address, and telephone number of the proposed Principal Investigator and other key personnel; the identities of proposed consortia members, including any other participating organizations or institutions; a descriptive title of the proposed demonstration project; and the number and title of the 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. The letter of intent is to be sent to the CAHPS project officer at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on research grant application form PHS 398 (rev. 9/91). State and local government applicants may use form PHS 5161, Application for Federal Assistance. These forms are available at most institutional offices of sponsored research; the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 594-7248. For AHCPR, applications are available from Global Exchange Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, telephone (301) 656-3100, Fax (301) 652-5264. The RFA label available in the PHS 398 (rev. 9/91) application form must be affixed to the bottom of the face page of the application. Failure to use this label 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 2a on the face page of the application form and the YES box must be marked. Complete information must be submitted with the application. Consortium arrangements typically take the form of a formal agreement between an applicant and other organization(s). In the grant application, a separate budget page and budget justification must be included for each organization involved in the proposed consortium arrangement. Submit a signed, typewritten, original of the application, including the Checklist, and three signed legible copies (two copies when using the PHS 5161) in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express mail or courier) Applications submitted under this RFA must be received by June 20, 1995, by the Division of Research Grants, NIH. If an application is received after that date, it will be returned to the applicant. At the time of submission, two additional copies of the application (one copy when using the PHS 5161) must be sent to the CAHPS project officer at the address under INQUIRIES. Conference for Prospective Applicants The AHCPR plans to convene a conference for prospective applicants on April 5, 1995 in Rockville, Maryland. Attendance is not a prerequisite to applying. Attendees must pay for their own travel and accommodation costs. For further information, contact (301) 594-1357 ext 105. REVIEW CONSIDERATIONS All applications will be judged on the basis of the scientific and technical merit of the proposed project and the documented ability of the investigator to meet the objectives of the RFA. Upon receipt, applications will be reviewed for completeness by the Referral Office, Division of Research Grants, NIH, and by AHCPR staff for responsiveness to the RFA. Incomplete and nonresponsive applications will be returned to applicants without further consideration. The determination of any application as nonresponsive will be the sole responsibility of AHCPR. All accepted applications will undergo peer review for scientific and technical merit by a special review group convened by the AHCPR. Review criteria for AHCPR grant applications are: significance and originality from a scientific and technical viewpoint; adequacy of the method; availability of data or proposed plan to collect data required for the project; qualifications and experience of the Principal Investigator and proposed staff; adequacy of the plan for organizing and carrying out the project; reasonableness of the proposed budget; and adequacy of the facilities and resources available to the applicant. Although the technical merit of the proposed protocol is important, it is not the sole criterion for selection of the awardee(s). Applications may undergo triage by the peer review group on the basis of relative scientific and technical competitiveness. The AHCPR will withdraw from further consideration those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. When an application is reviewed, the peer review committee may recommend further consideration or no further consideration. The committee also assigns priority scores to the applications for which further consideration is recommended. Recommendations of the peer review committee may be reviewed subsequently by AHCPR's National Advisory Council for Health Care Policy, Research, and Evaluation. The peer review process is rigorous, and only those applications judged to be of greatest merit will be recommended for further consideration. Special Review Criteria In addition to the review criteria noted above, the review committee will evaluate each application in response to this RFA against the following special scientific and technical review criteria: 1. Understanding of issues related to completing the activities outlined in OBJECTIVES AND SCOPE and STUDY DESIGN. 2. Understanding of all issues related to the measurement of consumer assessments of health care plans and services. 3. Understanding of the needs of various audiences who may use health care information (e.g., consumers, purchasers, plans, providers, payers, State and local-level health care organizations) and the ways in which they may use this information (selection of plans and providers; comparison of plan/provider performance; identification of local or multi-site quality problems). 4. Demonstrated experience in the performance of all aspects of fielding a large-scale, multi-site survey, including but not limited to: formulation of a methodologically sound design; performance of validity and reliability studies on large-scale survey instruments; identification and resolution of methodological issues associated with sample selection and sample size, and with administration of surveys to the subpopulations of interest and within a variety of health care delivery settings; identification and resolution of methodological issues associated with mode of administration. 5. Demonstrated ability to produce detailed survey operations manuals suitable for use by groups with minimal as well as extensive experience in fielding large-scale, multi-site surveys. 6. Demonstrated ability to cooperate with, provide technical assistance or training to, and/or monitor the progress of potential collaborating organizations or test sites; particularly, other groups such as consortium members, subgrantees, subcontractors, community-based organizations, data supplying organizations, respondents, and site representatives. 7. Demonstrated ability to collaborate with government agencies in the performance of research studies and demonstrations. 8. Demonstrated ability to develop and test attractive, understandable, usable health-related materials for a variety of consumers. 9. Demonstrated ability to design and implement process and outcome evaluations, including: specification of evaluation questions and outcome measures; use of quantitative and qualitative data collection methods; data analysis; development of data-based recommendations and use of the recommendations to improve products and procedures. AWARD CRITERIA Applications will compete for available funds with all other applications for this RFA. The following will be considered in making funding decisions: quality of the proposed project as determined by scientific and technical merit; program balance, including the likelihood of successful collaboration based upon sufficient compatibility of features; and availability of funds. The earliest anticipated date of award is September 30, 1995. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. Copies of this RFA and background documents are available from: Global Exchange Inc. 7910 Woodmont Avenue, Suite 400 Bethesda, MD 20814-3015 Telephone: (301) 656-3100 FAX: (301) 652-5264 Copies of the RFA without background materials can also be requested by e-mail at cahpsrfa@PO3.AHCPR.GOV, the NIH GOPHER (gopher.nih.gov), and AHCPR InstantFAX at (301) 594-2800, AHCPR Pub. No. 95-0044. To use InstantFAX, you must call from a fax machine with a telephone handset. Use the key pad on the receiver when responding to prompts >From InstantFAX. The RFA will be sent at the end of the ordering process. AHCPR InstantFAX operates 24 hours a day, 7 days a week. For questions about this service, call AHCPR's Division of Communications at (301) 594-1364 ext. 159. Direct inquiries regarding programmatic issues, including information on the policy of inclusion of women and minorities in study populations, to: Christine Crofton, Ph.D. CAHPS Project Officer Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 603 Rockville, MD 20852-4908 Telephone: (301) 594-1357 ext 105 Direct inquiries regarding fiscal matters to: Mr. Ralph L. Sloat Grants Management Officer, Office of Management Agency for Health Care Policy and Research 2101 East Jefferson Street, Suite 601 Rockville, MD 20852-4908 Telephone: (301) 594-1447 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.226. Awards are made under authorization of the Public Health Service Act, Title IX (42 U.S.C. 299-299c-6). 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. 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 routing 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. From owner-sci-resources@net.bio.net Tue Mar 07 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HS-95-004 - V24(09) 03/10/95 Date: 8 Mar 1995 15:07:19 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 453 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3jldb7$pv6@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA HS95004 HS-95-004 P1O1 *************************************** HEALTH SERVICES RESEARCH ON ADVANCE DIRECTIVES NIH Guide, Volume 24, Number 9, March 10, 1995 RFA: HS-95-004 P.T. 34; K.W. 0730021, 0730052 Agency for Health Care Policy and Research Letter of Intent Receipt Date: May 15, 1995 Application Receipt Date: June 20, 1995 PURPOSE The Agency for Health Care Policy and Research (AHCPR) is soliciting applications for research on advance directives. Research applications are invited for establishing and evaluating a pilot study of the effectiveness of a community focused, home-based approach to completion of advance medical care directives by individuals. HEALTHY PEOPLE 2000 The Public Health Service (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 urges 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 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign non-profit organizations, public and private, including universities, clinics, units of State and local governments, non-profit firms, and non-profit foundations. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This request for applications will use the research project grant (R01) mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. This is a one-time solicitation. The total requested project period may not exceed two years. FUNDS AVAILABLE The AHCPR expects to make one award of up to $700,000 (total cost) over a two-year period to meet the objectives of this RFA. Funding for the first year will not exceed $350,000 total cost. This is a one time solicitation, with the first year of funding to be awarded in Fiscal Year 1995. No award will be made if, as a result of the scientific and technical review, none of the applications is judged to be of high merit. Continuation of the grant for the second year will depend on evaluation of a one-year progress review by AHCPR, and the availability of funds. RESEARCH OBJECTIVES Definition and Significance An advance directive is a means of recording a person's preferences regarding future health care decisions while the person is fully competent. Such recorded preferences may be used to guide the actual decisions that are made at a later time, should the person become incompetent. Advance directives commonly take one of two forms. A living will records the person's health care preferences in the event he or she has a terminal illness. The other form, the durable power of attorney for health care, sometimes called "medical power of attorney," or "health care proxy," records the individual chosen by the person to make decisions on his/her behalf if necessary. Thus, one form of advance directive focuses on what health care will be chosen, while the other focuses upon who is most trusted by the patient to do the choosing. These goals are not mutually exclusive and combined forms of advance directives are increasingly common. Advance directives are designed to accomplish a number of functions. They protect an individual's right to choose or to refuse various forms of health care, even in the face of the development of decisional incapacity. They provide additional assurance that the care provided for an incompetent patient will actually match that patient's personal values. They transfer a critical health-care decision point from the time of a patient's decisional incapacity to an earlier time when the person is fully competent. Historical Background In the decade of the 1960s, medicine introduced a number of technologies capable of prolonging life in critically ill patients, including cardiopulmonary resuscitation, mechanical ventilation, and renal dialysis. For a time, the excitement over the initial success of these treatments displaced concerns about the negative impact of such technologies upon patient autonomy, or about the balancing of the value of life's quality with its quantity. In concert with these technological advances, the field of biomedical ethics expanded greatly between 1970 and 1985. Early biomedical ethics discussions focused upon the value of patient autonomy, and the right of the competent patient to choose or to refuse various forms of medical care, including life-prolonging therapy. Around 1970, the earliest form of "living will" was introduced. The importance of respect for informed consent as a guiding ethical principle was firmly entrenched by the time the President's Commission for the Study of Ethical and Legal Problems in Medicine and Biomedical and Behavioral Research issued its 1983 influential report, Deciding to Forego Life-Sustaining Treatment (U.S. Government Printing Office, Washington, DC Stock number: 040-000-00470-0). That report encouraged the use of advance directives and popularized use of the generic term. Concern about use of life-sustaining technologies was outlined in two Office of Technology Assessment reports (U.S. Congress, Office of Technology Assessment: Life-Sustaining Technologies and the Elderly, OTA-BA-306, Washington, DC, U.S. Government Printing Office (GPO), July 1987; and, Institutional Protocols for Decisions about Life-Sustaining Treatments--Special Report, OTA-BA-389, Washington, DC, GPO, July 1988). More recently, the value of advance directives has been generally assumed, and attention has been devoted to refining and improving the various forms or documents which can be used to record patient preferences. At the same time, empirical research has been conducted, and many more data are available about the prevalence and effectiveness of advance directives. AHCPR has funded much of the empirical research on this question, having 10 projects currently underway and 7 projects completed. Research has been conducted in hospitals, nursing homes, physicians' offices, and the community. The Patient Self-Determination Act In 1990, Congress, prompted by concerns similar to those expressed by the President's Commission report of 1983, and by the low rates of execution of directives among the population, passed the Patient Self-Determination Act. This law directs that all patients admitted to Medicare and Medicaid certified providers, including hospitals, nursing facilities, hospices, home health agencies, and pre-paid health plans must receive some form of counselling regarding their right to refuse medical treatment and their right to complete an advance directive under the laws of their State. Patients must be asked whether they already have an advance directive, and if they do, the directive must be made part of the medical record in a manner that assures easy retrieval in a later emergency. Institutions are also required to perform some type of public outreach and education around advance directives. Some have argued that passage of this law solved the advance directive "problem" and that further research is not needed to guide policy. However, the law does not mandate discussion of advance directives in most outpatient, primary care settings, where many experts feel that these discussions would optimally occur. Given the disappointing advance directive completion rates in studies where experienced primary care providers spent a good deal of time educating and counselling patients, it is reasonable to question whether the often perfunctory methods many hospitals have used to comply with the law, such as having the admitting clerk hand the patient a brochure, could possibly have any beneficial effect. Additionally, many providers have interpreted the Patient Self-Determination Act as if it were focused solely on do-not-resuscitate (DNR) orders. This points out the problem, that while an individual's plans may be for a broad scope and level of care at the end of his or her life, these plans may be reduced to the very narrow question of whether the patient is a "DNR" or "full code." Decisions may be made as if cardiopulmonary resuscitation were the only decision that matters, or cardiopulmonary arrest is the only medical contingency for which advance planning is desirable. Also, many practitioners do not discuss advance directives with their patients even though their patients may be willing to do so (Loewy EH, Carslon RW. Archives Internal Medicine 1994; 154:2265-7). While the Patient Self-Determination Act may have changed the practice environment in a positive direction, the need for research in advance directives persists. This was recognized by the Senate Appropriations Committee which directed AHCPR to support a study in this area (S.103-318). Future Research Needs A conference was held in September 1993, supported by AHCPR, the Greenwall Foundation, The Kornfeld Foundation, and the Walter and Elsie Haas Fund. The purpose of the conference was to assess the current state-of-knowledge about decision-making for incapacitated adults, giving special attention to the role of advance directives and aiming to establish priorities for further theoretical and empirical research in this area. This invitational working conference assembled 36 leading investigators to make recommendations on the priorities for both theoretical and empirical research in the wake of the Patient Self-Determination Act. Conference participants reached consensus that future research on advance directives should focus on a broad process of communication that participants called "advance care planning." The consensus statement derived from this conference was published in a Special Supplement to the Hastings Center Report (November-December 1994 issue) entitled "Advance Care Planning: Priorities for Ethical and Empirical Research." Potential applicants under this RFA are encouraged to read this report. It is available from the National Technical Information Service (NTIS) order number PB95-147740. A limited number of copies are available >From program staff listed under INQUIRIES. Specific Goals of this RFA Research under this RFA should address the issue of the low percentage of the general public who have completed an advance medical directive. Specifically, this RFA calls for a pilot project to assess the effectiveness of a community focused, home-based approach to encouraging the completion of advance medical directives, including bona fide advance directives documentation. The pilot project should be initiated in four geographic and ethnically diverse locations. It is desirable that the research should evaluate the validity of advance directives executed in this setting. Validity includes the concepts of accuracy and of stability. Accuracy in this context is the issue of how well the advance directive explains or is consistent with the person's true desires. Stability refers to how long the advance directive actually represents the person's desires. The research should address differences in motivational and procedural barriers to completing an appropriate living will or health care power of attorney. SPECIAL REQUIREMENTS 1. The AHCPR does not endorse, recommend or specify which or what particular documentation is to be used. However, it is expected that the applicant will specify and justify the advance directive documentation to be used with respect to validity, reliability, and stability of patient preferences for life sustaining treatment. 2. This pilot project should be administered by an organization with a demonstrated record of education achievements in adult learning and community involvement. The organization should affiliate with an academic institution experienced in this area. The research design must be rigorous. 3. The applicant's literature review should demonstrate evidence of substantive understanding of advance directives research supported by AHCPR as to avoid duplication and to enhance utilization of prior research. Applicants may obtain a listing of AHCPR supported projects from program staff listed under INQUIRIES. 4. The proposed research design should be sensitive to the consensus statement on behalf of the September 1993 conference participants that appears in the Special Supplement (pp S32-36) to that statement, noted above. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of AHCPR that women and members of minority groups must be included in all AHCPR supported health services 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. A new NIH policy resulting from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) supersedes and strengthens NIH's previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which were in effect since 1990 and which AHCPR had adopted. The new NIH policy contains some provisions that are substantially different from the 1990 policies. AHCPR plans to publish guidelines specific to AHCPR. In the interim, AHCPR will follow the NIH guidelines, as applicable. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of this policy from the AHCPR program staff listed under INQUIRIES. AHCPR program staff may also provide additional relevant information concerning this policy. LETTER OF INTENT Prospective applicants are asked to submit, by May 15, 1995, a letter of intent that includes a descriptive title of the proposed research; the name, address, and telephone number of the Principal Investigator, co-investigators and other key personnel; the applicant institution 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. The letter of intent should be sent to: Julius Pellegrino Agency for Health Care Policy And Research 2101 East Jefferson Street, EOC/Suite 502 Rockville, MD 20852-4908 APPLICATION PROCEDURES Applications are to be submitted on research grant application form PHS 398 (rev. 9/91). State and local government agencies may use form PHS 5161 and follow those requirements for copy submission. These forms are available at most institutional offices of sponsored research; and the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892. Applications for AHCPR support are also available from Global Exchange Inc., 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3015, telephone 301-656-3100 (FAX 301-652-5264). The RFA label available in the form PHS 398 (rev. 9/91) must be affixed to the bottom of the face page of the original application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, type "RFA HS-95-004" in Section 2a on the face page of the application form and mark the "YES" box. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express mail) At the time of submission, two additional copies of the application must be sent to: Julius Pellegrino Agency For Health Care Policy And Research 2101 East Jefferson Street, EOC/Suite 502 Rockville, MD 20852-4908 Applications submitted under this RFA must be received in the Division of Research Grants, NIH, by June 20, 1995. If an application is received after that date, it will be returned to the applicant without review. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the Referral Office, Division of Research Grants, NIH, for com