From owner-sci-resources@net.bio.net Wed Feb 01 22:00:00 1995 Path: biosci!hubcap.clemson.edu!biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS - 29 January 1995 Date: 30 Jan 1995 14:56:55 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 109 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3gjqrn$3kc@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: Dir of Awards Title: NSF 94-162 SUMMARY OF AWARDS FISCAL YEAR 1993 File size (bytes): 177040 STIS Filename: nsf94162.txt Title: NSF 95-25 NSF Awards First Series of Networking Infrastructure for Education (NIE) Grants File size (bytes): STIS Filename: nsf9525a.txt Title: NSF 95-25 NSF Awards First Series of Networking Infrastructure for Education (NIE) Grants File size (bytes): STIS Filename: nsf9525b.txt Document Type: Press Release Title: PR 95-2 -- TOWARD UNDERSTANDING THE BEATING OF THE HEART File size (bytes): STIS Filename: pr952.txt Document Type: Program Guideline Title: NSF 95-9 Methods and Models for Integrated Assessment, Research Opportunity Related to the NSF Global Change Research Program File size (bytes): STIS Filename: nsf959.txt Document Type: Recruit Title: Assistant Counsel to the Inspector General File size (bytes): STIS Filename: vex9512a.txt Title: Supervisory Computer Specialist (Section Head) File size (bytes): STIS Filename: vgs9555.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: Current List of REU Sites File size (bytes): 87608 STIS Filename: reulist.txt Title: Current List of REU Sites File size (bytes): 87608 STIS Filename: reulist.txt Document Type: Phone Book Title: NSF Alpha Telephone File size (bytes): 96548 STIS Filename: phnalpha.txt Title: NSF Organizational Directory File size (bytes): 98572 STIS Filename: phnorg.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 phnorg.txt, the text of your message should be as follows: get phnorg.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve phnorg.txt, you would enter: ftp> get phnorg.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 Fri Feb 03 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DA-95-003 - V24(04) 02/03/95 Date: 3 Feb 1995 22:13:45 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 473 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3gv5up$p70@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA DA95003 DA-95-003 P1O1 *************************************** HUMAN BASIC AND CLINICAL NEUROSCIENCE OF DRUG ADDICTION NIH GUIDE, Volume 24, Number 4, February 3, 1995 RFA: DA-95-003 P.T. 34; K.W. 1002030, 0404009, 0404001 National Institute on Drug Abuse Letter of Intent Receipt Date: April 3, 1995 Application Receipt Date: May 9, 1995 PURPOSE A generation of neuroscientific research utilizing animal models has provided the identification of receptors for every major abused drug and many of their endogenous ligands. A variety of models have been developed to explain the fundamental behavioral and biological mechanisms of addiction, e.g., brain reward, tolerance, and dependence. These discoveries and models, coupled with the rapid advances in noninvasive brain imaging methodology, now make it feasible to study drug addiction and the human brain to determine the etiology and the biomedical and biobehavioral consequences of drug abuse, as well as the effects of treatment of this disorder. The National Institute on Drug Abuse (NIDA) proposes to initiate a major program using noninvasive technologies or autopsy materials to study the human brain and the etiology and consequences of drug abuse and to translate this information into novel prevention, diagnostic, and treatment strategies. Research applications proposing to use current or to develop new noninvasive techniques to assess neuroanatomical, neurochemical, or other functional differences or changes in human brain that contribute to vulnerability to drug abuse, are a consequence of drug use, or result from pharmacological or non- pharmacological treatment are therefore invited. Investigators interested in research of this type with respect to AIDS etiology, consequences, and treatment in connection with drug abuse and addiction are particularly encouraged to apply. 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), Human Basic and Clinical Neuroscience of Drug Addiction, is related to the priority areas of tobacco, alcohol and other drugs, and maternal and infant health. 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 foreign and domestic, for-profit and nonprofit organizations, public and private such as colleges, universities, hospitals, laboratories, units of State and local government, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the NIH research project grant (R01), exploratory/developmental research award (R21), FIRST (R29) award, and small grant (R03). Investigators may also respond to this RFA under the Interactive Research Project Grant Program (IRPG), which utilizes the R01 and R29 mechanisms. If an IPRG is proposed, it must consist of a minimum of two independent applications (see PA-94-086, NIH Guide for Grants and Contracts, Vol. 23, No. 28, July 29, 1994). However, if the IRPG mechanism is used under this RFA, the receipt date of this RFA takes precedence over the IRPG special receipt date. Research grants are awarded to institutions on behalf of Principal Investigators who have designed and will direct a specific project or set of projects. FUNDS AVAILABLE It is anticipated that approximately $3 million will be available to support projects submitted under this RFA. Because the nature and scope of the research proposed in response to this RFA may vary, the size of an award will vary also. It is anticipated that approximately 8 to 10 new awards will be made under this RFA. RESEARCH OBJECTIVES This program is intended to support research on basic and clinical human neuroscience of addiction. Research using animals is not excluded, but their use in projects submitted under this RFA must be specifically justified. Effort is to be made to use state-of-the-science approaches. Individual research project grants funded under this RFA may conduct research that uses various imaging or other innovative technologies, living neural tissue, or postmortem tissue to: 1. elucidate in humans the basic mechanisms of action of drugs of abuse, including interaction with other drugs and with mental or physical conditions, such as psychiatric disorders or AIDS; 2. examine the neurobiological factors, including those related to AIDS, that contribute to vulnerability to drug abuse; 3. examine the central nervous system (CNS) status of patients during diagnosis and treatment for drug dependency disorders; HIV infected persons or persons with AIDS may be special populations for such studies. 1. Basic Human Neuroscience Investigators are invited to study the effects of substance abuse on the structure and function of the human brain using various imaging and other technologies (e.g., ligand PET scanning, functional magnetic resonance imaging, magnetic source imaging, electroencephalography, magnetic resonance spectroscopy), autopsy material, or other methods (e.g., neural tissue transplantation, neuron cultures, analytical neurochemistry). The main goals of the basic research supported through this initiative are to: (1) identify in humans the neuronal systems involved in mediating the pleasurable or reinforcing experiences associated with substance abuse (the human brain reward system), and (2) characterize in humans the neurochemical, neuroanatomical, and neurophysiological changes that underlie states of drug tolerance and dependence, as well as to characterize the reversible and irreversible brain changes that result from drug abuse. Investigators are further encouraged to verify in man observations made in animal studies that drug abuse produces long-lasting changes in neurochemical markers and morphological features of specific sets of neurons. The effects of different types of drugs of abuse on neurochemical markers could be assayed in postmortem human brain tissue samples. Such studies should measure fundamental neuronal and glial structure and function including morphology, activity of enzymes involved in neurotransmitter synthesis and degradation, receptor densities and distribution, second messenger systems, and measurements of gene expression. Changes in these due to drug- related HIV infection are also subjects of interest. Of particular interest are studies that will take advantage of the opportunity to correlate directly the changes in the patterns of biologic activity in the human brain with the subjective experiences of the individual exposed to drugs of abuse. This research should help elucidate the precise neural mechanisms affected by drugs of abuse as well as reveal how drug-induced alterations might lead to and maintain drug-seeking behavior and addiction. Also important are studies assessing brain function during various stages of withdrawal and abstinence, which should provide important information about the neural substrates involved in drug craving. Studies are also encouraged that would refine current imaging techniques or develop new ones, elucidating the basic mechanisms and correlations that relate images to neuronal activity, for example, establishing the mathematical relationships between blood flow, metabolism, and cellular activity, or providing greater levels of refinement for viewing anatomical structures; e.g., applications of magnetic resonance microscopy which attempt to provide resolution at the cellular level. Again, alterations due to drug-related HIV infection are suitable topics for this request for applications. Research in the chemistry necessary to human brain imaging is also encouraged, for example, the synthesis of novel imaging reagents for use in humans. Another area of interest is the application of imaging technologies to pharmacokinetics. 2. Vulnerability and Etiological Investigations In humans, neurobiological factors that relate to high vulnerability to abuse drugs or to high vulnerability to suffer the adverse health consequences of drug abuse are not currently defined. NIDA is also interested in research on neurobiological aspects of drug abuse that might be unique to special groups, such as women and youth. In this connection, NIDA also encourages applications that focus specifically on HIV positive populations or individuals at risk for acquiring AIDS. Applications for support under this RFA will use original approaches to apply the latest in imaging and other innovative techniques to the examination of neurobiological factors underlying the etiology of and vulnerability to drug abuse in humans. Such projects might use noninvasive techniques to: a. Examine factors contributing to the biomedical etiology of drug abuse; for example, studies evaluating genetic, developmental, and environmental factors in drug addiction, including nutritional and environmental toxic elements; or examining the neurobiological relationship between early use of tobacco and alcohol and later development of cocaine and heroin addictions. b. Identify the type and distribution of the biomedical consequences of abusing drugs because of as-yet-unidentified neurobiological predispositions. c. Assess the prevalence, distribution, and epidemiology of biobehavioral risk factors underlying the vulnerability to abuse drugs. This might include investigations of the role of various stressors in vulnerability to drug addiction (e.g., links between post traumatic stress disorders and drug seeking behaviors or between HIV infection and drug addiction). d. Modify and further develop existing technologies and methodologies for studying the neurobiological risk factors of drug abuse. Projects should develop new information about how individual differences in genetics, neurobiological profiles, or psychological behaviors predict drug abuse or, alternatively, protect from drug abuse. 3. Clinical and Treatment Neuroscience Clinical and treatment-oriented neurobiological researchers are encouraged to submit applications that utilize state-of-the-art brain imaging, analytical neurochemistry, electrophysiology, neuropsychological assessment, genetic analysis, and other technology to elucidate the CNS status of patients during various stages of diagnosis and treatment of drug dependency disorders. For example, studies might examine neurotransmitter metabolites appearing in blood and cerebrospinal fluid as neurochemical markers for diagnosis, as correlates of mood and behavior, and as predictors of clinical outcome. This example also encompasses metabolic changes in response to various treatment interventions, pharmacological, behavioral, and psychosocial. It is important to describe the changes that occur in the endogenous opioid system, neuroendocrine system, and other neuronal systems in patients throughout all stages of the addictive process, including protracted abstinence, response to treatment, recovery, and long-term cognitive, perceptual, motor, or other deficits resulting from drug abuse. HIV-positive subjects or AIDS patients might be special populations in such applications. Studies evaluating the relationship between drug seeking behavior and preexisting neurological deficits, particularly hypofrontality and attention deficit hyperactivity disorders, or the comorbidity of drug use and of other mental disorders, especially depression, schizophrenia, anti-social personality, or AIDS-related dementia, are also encouraged. Research investigating the relationship between drug abuse and development of various neurological disorders such as Parkinson's disease, Alzheimer's disease, etc., is also of interest. Since many drug addicts are polydrug abusers, studies to investigate the neurological, neurochemical, pharmacological, pathological, and psychological consequences of interactions among abused drugs, such as cocaine, heroin, alcohol, nicotine, marijuana, anabolic steroids, and inhalants, are also encouraged. SPECIAL REQUIREMENTS The exploratory/developmental grant (R21) and small grant (R03) applications are limited to two years, are non-renewable, and are limited in direct cost amount per year (R03, $50,000; R21, $90,000). The R03 mechanism is intended for new, inexperienced investigators and both are intended for established investigators exploring new areas or departing from their usual research topics. There are special requirements for these mechanisms. An applicant intending to apply for them under this RFA should contact the program person listed under INQUIRIES for further information. 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 subpopulations 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 new 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 program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 3, 1995, a letter of intent that includes a descriptive title of the proposed research, the proposed mechanism of support, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institution, 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 review of subsequent applications, the information that it contains allows NIDA 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: Director Office of Extramural Program Review, NIDA 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Telephone: (301) 443-2755 FAX: (301) 443-0538 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research, and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 240, Bethesda, MD 20892, telephone 301-594-7248. FIRST award (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The RFA label in the PHS 398 must be affixed to the bottom of the original face page. Failure to use the RFA 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 in Item 2a on 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 photocopies in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: Director Office of Extramural Program Review National Institute on Drug Abuse 5600 Fishers Lane, Room 10-42 Rockville, MD 20857 Applications must be received by May 9, 1995. If an application is received after that date will be held for the next regular receipt date and reviewed under standard circumstances. However, it will not be considered as a response to this RFA. The Division of Research Grants (DRG) will not accept any application in response to the RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) and responsiveness by NIDA. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, the applicant may be contacted to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific/technical merit by an appropriate peer review group convened by NIDA in accordance with the review criteria stated below. As part of the initial merit review, a triage will be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to this RFA. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Review Criteria o scientific, technical or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The anticipated date of award is September 30, 1995. Applications recommended for further consideration by the NIDA Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the application as determined by peer review, appropriateness of budget estimates, program needs and balance, policy considerations, adequacy of provisions for the protection of human subjects, and availability of funds. Special award criteria apply to R03 and R21 mechanisms. Applicants should contact the program person listed under INQUIRIES. INQUIRIES 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: Harold W. Gordon, Ph.D. or Arthur Horton, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-38 Rockville, MD 20857 Telephone: (301) 443-4877 Email: hgordon@aoada.ssw.dhhs.gov Direct inquiries regarding fiscal or grants management issues to: Chief, Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 Email: gfleming@aoada.ssw.dhhs.gov The National Institute of Mental Health is not participating in this RFA, but continues to fund research in the area of basic human neuroscience through the unsolicited grant application process. For more information contact: Dr. Israel Lederhendler Systems Neuroscience Program National Institute of Mental Health 5600 Fishers Lane, Room 11-102 Rockville, MD 20857 Telephone: (301) 443-1576 FAX: (301) 443-4822 AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Section 301, and administered under PHS grants policies and Federal Regulations at Title 42 CFR 52 "Grants for Research Projects," Title 45 CFR Part 74 & 92, "Administration of Grants," and 45 CFR Part 46, "Protection of Human Subjects." Title 42 CFR Part 2, "Confidentiality of Alcohol and Drug Abuse Patient Records" may also be applicable to these awards. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant 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 Fri Feb 03 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-95-007 - V24(04) 02/03/95 Date: 3 Feb 1995 22:14:36 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 904 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3gv60c$p96@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA AI95007 AI-95-007 P1O1 *************************************** NATIONAL COOPERATIVE INNER-CITY ASTHMA STUDY NIH GUIDE, Volume 24, Number 4, February 3, 1995 RFA: AI-95-007 P.T. 04; K.W. 0715013, 0710030, 1007003 National Institute of Allergy and Infectious Diseases National Institute of Environmental Health Science Letter of Intent Receipt Date: April 15, 1995 Application Receipt Date: June 15, 1995 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health (NIH) invite applications from institutions wishing to serve as Asthma Study Centers for the National Cooperative Inner-City Asthma Study (NCICAS), as well as the central Data Coordinating Center for all participating Asthma Study Centers. This cooperative, multi-center study seeks to reduce the disproportionate burden of asthma morbidity among underserved, inner- city children and adolescents from 4 to 12 years of age. Underserved, inner-city populations are defined as those having low socioeconomic status and residing in urban areas. The goal of this study is to design and evaluate an asthma intervention, based in health care delivery settings, aimed at reducing asthma morbidity in a cost-effective manner. Health care delivery settings are defined as medical clinics, hospital clinics, or emergency room clinics. Because of the multifaceted nature of asthma, a broad-based approach to the intervention is required. The intervention will involve all of the following elements: improving asthma treatment by physicians, increasing asthma self-management by asthmatics and their families, and environmental interventions. The specific components should be derived from the experience and findings generated by the initial NIAID-sponsored NCICAS, 1991-1996, existing asthma knowledge, pre- existing asthma interventions or programs, and/or new innovative approaches to this problem. HEALTHY PEOPLE 2000 The Public Health Service 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), the National Cooperative Inner-City Asthma Study, is related to the priority areas of environmental health, diabetes and chronic disabling diseases, and age-related objectives pertaining to children. 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 for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local government, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Domestic applications may not include international components. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. All applicants must apply to participate as an Asthma Study Center. Applicants may also apply to participate as both an Asthma Study Center and the central Data Coordinating Center. Two separate applications will be required from institutions applying for both an Asthma Study Center and the central Data Coordinating Center, including a specific plan for how the independent operation of each unit will be maintained as required. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Cooperative Agreement (U01), 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 cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of a study funded under cooperative agreement(s) are discussed under the section "Terms and Conditions of Award." The total project period for applications submitted in response to this RFA may not exceed five years. At this time, the NIAID and the NIEHS have not determined whether and how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE The estimated total funds (direct and indirect) available for the first year of support for awards under this RFA will be $2,250,000: $1,500,000 from the NIAID and $750,000 from the NIEHS. In Fiscal Year 1996, the NIAID and the NIEHS plan to fund up to 7 new and/or recompeting Asthma Study Centers, one of which will serve as the central Data Coordinating Center. Applications from institutions wishing to participate as Asthma Study Centers should not request first-year budgets in excess of $280,000 in total (direct and indirect) costs. Applications from institutions wishing to participate as both an Asthma Study Center and the central Data Coordinating Center should not request first-year budgets in excess of $300,000 in total (direct and indirect) costs to support the central Data Coordinating Center functions. The NIH is currently limiting annual inflationary increases to no more than four percent for future years of awards. 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 and the NIEHS, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES Background Asthma is one of the most common chronic diseases of childhood. Data >From the 1990 U.S. National Health Interview Survey indicate that nearly 3.7 million children, ages 17 years and less, suffer from asthma -- 5.8 percent of the U.S. population. Asthma morbidity and mortality have increased in recent years. Asthma prevalence increased by 40 percent among children less than 18 years of age during the 1980s, with African-American children having higher levels of asthma than white children. African-American children also experienced almost double the rate of increase in asthma hospitalization rates compared to white children during this time period. Little information on Latino children is available, but recent studies have found that Latino children in New York have very high levels of asthma prevalence and hospitalization. Although asthma deaths are still infrequent, mortality rates increased 6.2 percent per annum during the 1980s for 5 to 34 year olds; non-whites are two to three times more likely than whites to die from asthma. The economic costs of asthma are enormous despite its low mortality. In 1990, the cost of asthma in the United States was estimated to be $6.2 billion. Despite the widespread assumption that asthma is a mild illness, 43 percent of the cost was due to emergency room use, hospitalization and death. Most of the advances in asthma care during the 1960s and 1970s can be attributed to the development of better drugs to treat this disease. Despite the availability of these improved drugs, asthma is undertreated in the United States. Environmental factors play an important role in asthma. Air pollutants, such as nitrogen dioxide, ozone, sulfur dioxide, and particulates from diesel exhaust have been associated with worsening of asthma and higher levels of sensitization to allergens. The indoor environment has been the focus of interest, especially as individuals spend the majority of their life indoors. A wide variety of elements in the indoor environment have been associated with asthma, such as house dust mites, cockroach, cat, tobacco smoke and nitrogen dioxide. Many recent attempts at reducing asthma morbidity have focused on educational strategies. However, because of the multifaceted nature of this disease, particularly among underserved children and adolescents, a broad-based approach to intervention involving the provider, the patient, and the environment will be required to achieve a meaningful impact on disease burden. In 1991, the NIAID established the National Cooperative Inner-City Asthma Study, a two- part, five-year study undertaken at eight sites in seven sites nationwide. The objective of NCICAS Phase I (1991-1994) was to identify factors amenable to intervention that determine asthma severity and morbidity among inner-city children, ages 4 to 9 years. Preliminary results indicate that asthma morbidity is affected by lack of access to medical care, poor self-management skills, and environmental exposures. NCICAS Phase II (1994-1996) involves an intervention trial using an asthma counselor with a social work background to modify these factors in order to reduce asthma morbidity in these populations. The protocols for NCICAS, 1991-1996, Phases I and II will be available upon request from the NIAID program contact listed under INQUIRIES. Research Objectives and Scope Study Design This RFA solicits applications for a cooperative intervention study for underserved urban asthmatic children and adolescents, ages 4 to 12 years. Underserved urban populations are defined as those having low socioeconomic status and residing in urban areas. The objective of this cooperative study is to develop, implement, and evaluate a culturally-appropriate, comprehensive, and cost-effective intervention program aimed at reducing asthma morbidity by modifying those potentially reversible factors shown to contribute to asthma morbidity. The final study design will consist of a consensus core protocol with site-specific additions/modifications to address local issues. The core protocol will include all of the following elements: medical treatment for asthma delivered in a health care facility, self-management by asthmatics and their families, and indoor environmental interventions including studies to measure, monitor and improve the indoor environment. Although the major environmental focus of this cooperative study is the indoor environment, proposed protocols for innovative approaches may include major outdoor environmental factors. The core protocol may be modified by the individual Asthma Study Centers to tailor the core intervention to local populations, communities, or health care facilities. NOTE: Although the actual protocol to be conducted will be designed by the Steering Committee, applications must include a proposed protocol that meets the objectives and scope of this RFA. SPECIAL REQUIREMENTS A. Study Organization 1. Steering Committee A Steering Committee will be established to serve as the main governing body of the study. The Steering Committee will be composed of the Principal Investigator (or his/her designee) from each Asthma Study Center, one NIAID representative from the Office of Epidemiology and Clinical Trials, Division of Allergy, Immunology and Transplantation, hereafter designated the NIAID Study Coordinator, and one NIEHS representative, hereafter designated as the NIEHS Study Coordinator. Principal Instigators must be physicians with substantial experience in (1) asthma treatment, (2) asthma research, and (3) the design, implementation and evaluation of asthma intervention trials. All major scientific decisions will be determined by majority vote of the Steering Committee, with each Principal Investigator, the NIAID Study Coordinator, and the NIEHS Study Coordinator having one vote. The Chairperson will be selected by the Steering Committee from among the non-Federal members during the first meeting of the Committee, to be convened by the NIAID and the NIEHS Study Coordinators. The Director of the central Data Coordinating Center shall serve as a non-voting member of the Steering Committee and shall participate in all Committee activities in an advisory capacity. The Steering Committee will meet at least two times during the first 12 months of the study and at least annually thereafter. The Steering Committee will have primary responsibility for: developing the consensus core protocol; approving site-specific modifications to the core protocol as necessary to tailor the core intervention to local populations, communities, or health care facilities; facilitating the conduct and monitoring of the study; determining analyses to be performed using the collective data base; interpreting study data; and reporting study results. The study will proceed into the implementation stage only with the concurrence of the awardees, the NIAID Study Coordinator, and the NIEHS Study Coordinator. Each Principal Investigator (or his/her designee) will be expected to participate in all other Steering Committee activities, e.g., conference calls, special subcommittees as may be necessary, etc. Subcommittees of the Steering Committee may be established as necessary. 2. Data and Safety Monitoring Board An independent Data and Safety Monitoring Board, to be appointed by the NIAID and the NIEHS Study Coordinators with approval of the Steering Committee, will review progress at least annually and report to the NIAID and the NIEHS Study Coordinators. Protocols will be subject to review by the Data and Safety Monitoring Board in an advisory capacity. 3. Data Coordination, Management and Analysis Each Asthma Study Center will be responsible for: collecting all site-specific data for the consensus core protocol; submitting all such data to the Data Coordinating Center; and adhering to the policies and procedures established by the Steering Committee with respect to standardized data collection, data management, and protocol implementation and compliance. Applications for Asthma Study Centers should include in their budget requests support for all of these functions. The Data Coordinating Center will have primary responsibility for: the acquisition or creation of forms and/or materials for protocol implementation; quality control; uniformity of data collection; overseeing implementation of and adherence to the consensus core protocol; and storing, managing and analyzing data generated from the consensus core protocol. Specific analyses of the collective data base to be carried out by the Data Coordinating Center will be approved by the Steering Committee and the results of those analyses will be delivered to the Steering Committee as the group responsible for reviewing and approving the use and dissemination of study findings. The Data Coordinating Center will also be responsible for providing reports, at least annually, to the Steering Committee and, when appropriate, to the Data and Safety Monitory Board, concerning any and all of the above responsibilities, and for the planning and logistical arrangements of meetings of the Steering Committee and its subcommittees. Applications for the central Data Coordinating Center should include in their budget requests support for all of these functions. B. Terms and Conditions of Award The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the cooperative agreement (U01), 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 cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the study will be shared among the awardees, the NIAID Study Coordinator, and the NIEHS Study Coordinator. 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 the NIAID and the NIEHS Study Coordinators in all aspects of the scientific and technical management of the project. Specifically, awardees have primary responsibilities as described below. Steering Committee Membership and Meeting Attendance Each Principal Investigator (or his/her designee) will serve as a voting member of the Steering Committee and will participate in all scientific decisions. Each Principal Investigator (or his/her designee) will be responsible for attending all Steering Committee meetings, including not less than two meetings during the first 12 months of the study and one per year thereafter. The Steering Committee shall be responsible for determining the frequency of meetings and scheduling the time and location. Each Principal Investigator (or his/her designee) will be expected to participate in all other Steering Committee activities, e.g., conference calls, special subcommittees as may be necessary, etc. Subcommittees of the Steering Committee may be established as necessary. The Director of the Data Coordinating Center shall serve as a non- voting member of the Steering Committee and shall participate in all Steering Committee activities in an advisory capacity. Protocol Development and Conduct The Steering Committee will define the core protocol objectives and approaches within the areas of health care delivery, asthma self- management, and environmental controls. The Steering Committee will design the consensus core protocol and approve the site-specific additions to address local issues. With Steering Committee approval, the core protocol may be modified by the individual sites as necessary to tailor the core intervention to local populations, communities, or health care facilities. Each awardee will follow the procedures required by the Steering Committee regarding study conduct and monitoring, patient management, data collection, quality control, data analysis, and data presentation and publication. Data Coordination, Management and Analysis Each awardee will be responsible for: collecting all primary, site- specific study data; providing all such data to the Data Coordinating Center; and adhering to the policies and procedures established by the Steering Committee with respect to standardized data collection, quality and analysis, and protocol implementation and adherence. All data will be available to all awardees. The awardees will retain custody of and have primary rights to all data developed under these awards, subject to Government rights of access consistent with HHS, PHS, and NIH policies. Publication and Presentation of Study Findings Early publication of major findings is encouraged. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgement of the Asthma Study Centers, NIAID and NIEHS support. Analyses to be performed using the collective data from all Asthma Study Centers will be directed and coordinated by the Steering Committee. Asthma Study Centers performing analyses of local data will be subject to Steering Committee review and approval in order to avoid duplication. Review and approval by the Steering Committee will be required for all analyses prior to publication or presentation according to criteria that will be developed by the Steering Committee. Monitoring Study Progress The Steering Committee will establish mechanisms for assessing performance of the Asthma Study Centers, with particular attention to accrual of adequate numbers of eligible patients, timely submission and quality of required data, and conscientious observance of protocol requirements. Federally Mandated Regulatory Requirements Each Asthma Study Center is required to meet the DHHS/PHS regulations for the protection of human subjects and FDA requirements for the conduct of research using investigational agents. At a minimum, these include: o methods for assuring that each institution at which Asthma Study Center investigators are conducting clinical studies has a current, approved assurance on file with the Office of Protection from Research Risks (OPRR); that study protocols are reviewed and approved by the responsible Institutional Review Board (IRB) prior to patient entry; that active protocols are reviewed at least annually by the IRB; and that amendments are approved by the IRB. o methods for assuring or documenting that each patient, or patient's parent/legal guardian, gives fully informed consent to participation in a research protocol prior to the initiation of the experimental intervention. 2. NIAID and NIEHS Staff Responsibilities The NIAID and the NIEHS Study Coordinators 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. Steering Committee Membership and Meeting Attendance The NIAID and the NIEHS Study Coordinators will serve as voting members of the Steering Committee, will attend all Steering Committee meetings, and will participate in other Committee activities, e.g., conference calls, special subcommittees. Protocol Development As members of the Steering Committee, the NIAID and the NIEHS Study Coordinators will serve as resources with respect to the design of the protocol and will assist the Steering Committee in protocol development. The NIAID Study Coordinator will provide all protocols and available data from NCICAS, 1991-1996, for development of the core consensus protocol. Study Materials The individual Asthma Study Centers will be responsible for the acquisition of study materials required by the protocol. The NIAID and the NIEHS Study Coordinators will arrange for the appropriate approvals (when necessary) from the Food and Drug Administration (FDA) and the Bureau of Biologics (BOB) with respect to the use of investigational drugs. Monitoring Study Performance The NIAID and the NIEHS Study Coordinators will provide assistance to the Steering Committee in the development of mechanisms and procedures for monitoring study performance. This includes participation in periodic on-site monitoring with respect to compliance with protocol specifications, quality control and accuracy of data recording, and patient accrual. Data Coordination and Management Under the direction of the Steering Committee, the NIAID and the NIEHS Study Coordinators will provide technical guidance on data management to the Asthma Study Centers with respect to quality control, uniformity of data collection, management of the collective data base, and data analysis. The Government, via the NIAID and the NIEHS Study Coordinators, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. Information obtained from the data may be used by the NIAID and the NIEHS Study Coordinators for the preparation of internal reports on the activities of the study. However, awardees will retain custody of and have primary rights to all data developed under these awards. Publication and Presentation of Study Findings The NIAID and the NIEHS Study Coordinators may contribute, through review, comment, analyses, and/or co-authorship, to reporting results of the study to the investigator community and other interested scientific and lay organizations. Co-authorship by the NIAID and the NIEHS Study Coordinators will be subject to approval in accordance with NIH policies regarding staff authorship of publications resulting from extramural awards. Organizational Changes Certain organizational changes require the prior written approval of the NIAID and the NIEHS Study Coordinators. These changes include the addition/deletion of a physician, scientific investigator, affiliate, component, or research base that is associated with this study. A change in the Principal Investigator, or in any key personnel identified on the Notice of Award, must have the prior written approval of the NIAID and NIEHS Grants Management Specialists in consultation with the NIAID and the NIEHS Study Coordinators. Program Review The NIAID and the NIEHS Study Coordinators will review the progress of each Asthma Study Center through consideration of annual reports, site visits, patient logs, etc. This review may include, but is not limited to, compliance with the study protocol, meeting patient enrollment targets, adherence to uniform data collection procedures, and the timeliness and quality of data reporting. The NIAID and the NIEHS Study Coordinators reserve the right to terminate or curtail the study (or any individual award) in the event of (a) substantial shortfall in participant recruitment, follow-up, data reporting, quality control, or other major breech of the protocol, (b) substantive changes in the agreed-upon protocol to which the NIAID and the NIEHS Study Coordinators do not agree, (c) reaching a major study endpoint substantially before schedule with persuasive statistical significance, or (d) human subject ethical issues that may dictate a premature termination. 3. Collaborative Responsibilities A Steering Committee, composed of the Principal Investigators, the NIAID Study Coordinator, and the NIEHS Study Coordinator will be the main governing body of the study and will have primary responsibility for all scientific decisions, including: developing the consensus core protocol; approving site-specific modifications to the core protocol as necessary to tailor the core intervention to local populations, communities, or health care facilities; coordination of the site-specific protocol additions; facilitating the conduct and monitoring of the study; coordination and oversight of the development of data collection, management and quality control procedures; establishing procedures for assessing performance with respect to accrual, quality of data, and conscientious observance of protocol requirements; and coordinating and overseeing the analysis, interpretation, and publication of study data. Each member of the Steering Committee will have one vote. The Chairperson will be selected by the Steering Committee from among the non-Federal members. Subcommittees will be established by the Steering Committee as it deems appropriate. An independent Data and Safety Monitoring Board, to be appointed by the NIAID and the NIEHS Study Coordinators with Steering Committee approval, will review progress at least annually and report to the NIAID and the NIEHS Study Coordinators. The protocol will be subject to review by this Board in an advisory capacity. Awardees will be required to accept and implement the consensus core protocol and procedures approved by the Steering Committee. The study will proceed into the implementation stage only with the concurrence of the awardees, the NIAID Study Coordinator, and the NIEHS Study Coordinator. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award) between award recipients, the NIAID Study Coordinator, and the NIEHS Study Coordinator may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the Steering Committee (with the NIAID and the NIEHS Study Coordinators not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by the NIAID and the NIEHS Study Coordinators, and the third member selected by the two prior members. This special arbitration procedure in no way affects the awardee's rights to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR part 50, subpart D and HHS regulation at 45 CFR part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS The study population for this RFA is limited to underserved, inner- city children from 4 to 12 years of age. Within this population, NIH requirements for inclusion of women and minorities in study populations apply. It is the policy of the NIH that women and members of minority groups and their subpopulations 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 new 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 has 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 program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit by, April 15, 1995, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, the number and title of this RFA, and a list of the key investigators and their institution(s). 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 the NIAID and the NIEHS 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. Paula Strickland at the address listed under INQUIRIES. APPLICATION PROCEDURES 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. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number and the words "NATIONAL COOPERATIVE INNER CITY ASTHMA STUDY" must be typed in. Applications must address the requirements below. For Asthma Study Centers: 1. Applications should include a proposed protocol that meets the objectives and scope of this RFA, as well as a discussion of the rationale for the patient population, the study design and the intervention strategy selected for study, timeline for completion of the study, and an assessment of how anticipated study results can be expected to contribute to improvements in asthma morbidity among underserved urban children and adolescents with asthma. 2. The applicant institution must document its experience and capacity to recruit and retain study participants, provide a description of the population currently available for the proposed protocol, and describe proposed mechanisms for monitoring accrual performance and criteria for continued participation. 3. Applications must name a single Principal Investigator (PI) who will have scientific responsibility for the application as a whole including all Asthma Study Center-related research activities included under it. The PI must be a physician with substantial experience in (1) asthma treatment; (2) asthma research; and (3) the design, implementation and evaluation of asthma intervention trials. 4. Applications must name a Project Coordinator who is an individual with substantial technical/administrative experience in managing patient enrollment, patient follow-up, and multi-source data collection for intervention trials. 5. Applications must provide: a clear, concise plan in narrative and diagrammatic form that depicts the interrelationships among the members of the Asthma Study Center, their relevant experience/expertise, and the contribution of each to fulfillment of the objectives of this RFA; an organizational chart of the Asthma Study Center showing the name, organization, and scientific discipline of the PI and of all key scientific, technical and administrative personnel; and a mechanism for selecting and replacing key professional or technical personnel. 6. Applications must provide a plan to assure the maintenance of close cooperation and effective communication among members of the Asthma Study Center. 7. Applications should discuss the capability of the applicant organization to participate and interact effectively in a cooperative, multi-center asthma intervention trial. 8. Applications must include a written commitment to accept the participation and assistance of the NIAID and NIEHS Study Coordinators in accordance with the guidelines outlined under "Terms and Conditions of Award: NIAID and NIEHS Staff Responsibilities." The application must also include a written commitment to the cooperative organization and willingness to serve on the Steering Committee and adhere to the decisions reached by that Committee, including following the consensus core protocol. 9. All costs required for the proposed protocol must be included in the application and must be fully justified. These include the additional costs of clinical research associated with the proposed protocol, costs for patient recruitment and follow-up, laboratory studies, materials or forms required by the protocol, data collection and management, and participation in on-site quality assurance audits. Requested budgets should also include: (1) travel to the Washington, DC area for two 2-day Steering Committee meetings during the first 12 months of the study and annual Steering Committee meetings thereafter for the Principal Investigator. For the Data Coordinating Center: 1. Applications must provide documentation of the specific competence and previous experience of professional, technical and administrative staff pertinent to the operation of a Data Coordinating Center for a multi-center, cooperative clinical intervention, including prior experience in similar or related studies with respect to the collection, management and analysis of data from multiple sites and experience in monitoring the quality and timeliness of such data. 2. Applications must include a proposed plan for data management, quality assurance and analysis, as well as proposed methods for monitoring protocol implementation and adherence in similar and/or related projects. 3. Applications must describe the adequacy of the proposed facility, technical hardware, and space. 4. Applications must provide evidence of the degree of commitment and support of the institution for the proposed program, including the relative position of the proposed project staff within the applicant organization's structure. It is highly recommended that the Director of the Office of Epidemiology and Clinical Trials, NIAID Division of Allergy, Immunology and Transplantation or the Program Administrator, Organs and Systems Toxicology Branch, NIEHS Division of Extramural Research and Training, be contacted in the early stages of preparation of the application. (See program contacts listed under INQUIRIES.) Applications must be received by June 15, 1995. 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. The RFA label available in the PHS 398 must be affixed to the bottom of the face page. 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. Applications received after the receipt date will be returned without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. This does not exclude the submission of substantial revisions of an application already reviewed. These applications must, however, include an introduction addressing the previous critique. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-spaced photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** 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. Paula Strickland at the address listed under INQUIRIES. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator could be included with the application. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness by NIAID and NIEHS staff. Incomplete and non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non- competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator and the official signing for the applicant organization will be promptly notified. The second level of review will be provided by the NIAID and NIEHS Advisory Councils. Review Criteria Applicants are expected to address the requirements identified under APPLICATION PROCEDURES. The review criteria for applications in response to this RFA are: o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the 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: Peter J. Gergen, M.D.,M.P.H. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A29 6003 Executive Boulevard - MSC 7640 Bethesda, MD 20892-7640 Telephone: (301) 496-0982 FAX: (301) 402-2571 Email: pg17q@nih.gov George S. Malindzak, Jr., Ph.D. Division of Extramural Research and Training National Institute of Environmental Health Sciences 104 T. W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-3289 FAX: (919) 541-2843 Email: gm26f@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: Paula Strickland, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C02 6003 Executive Boulevard - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 402-0643 FAX: (301) 402-2638 Email: ps30f@nih.gov Direct inquiries regarding fiscal matters to: Ms. Linda M. Shaw Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C23 6003 Executive Boulevard - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: ls15k@nih.gov Schedule Letter of Intent Receipt Date: April 15, 1995 Application Receipt Date: June 15, 1995 Scientific Review Date: October 1995 Advisory Council Date: January 1996 Earliest Award Date: April 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance N0. 93.855, 93.113 and 93.115. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 43 USC 241 and 285) and administered under PHS grant policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free work place and promote the nonuse 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 Fri Feb 03 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-95-001 - V24(04) 02/03/95 Date: 3 Feb 1995 22:14:29 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 809 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3gv605$p8t@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA CA95001 CA-95-001 P1O1 *************************************** NATIONAL BLACK LEADERSHIP INITIATIVE ON CANCER NIH GUIDE, Volume 24, Number 4, February 3, 1995 RFA: CA-95-001 P.T. 34, FC; K.W. 0715035, 0745027, 0795003 National Cancer Institute Letter of Intent Receipt Date: March 3, 1995 Application Receipt Date: April 27, 1995 PURPOSE The National Cancer Institute (NCI), through the Division of Cancer Prevention and Control, Cancer Control Science Program, Special Populations Studies Branch, invites applications for a cooperative agreement award to continue building a vigorous cancer prevention and control outreach program for Black American communities. The program, entitled National Black Leadership Initiative on Cancer (NBLIC), has the immediate goals of involving community leaders in building new and maintaining previously established community cancer control coalitions, and addressing the barriers that limit Black Americans' access to quality cancer prevention, control, and treatment services. It is anticipated that such activities will lead to accomplishment of NBLIC's long-range goal of reducing cancer incidence and mortality rates, and increasing survival rates among Black Americans. Intermediate goals include improvements in knowledge and behavior of Black Americans about the prevention and early detection of cancer. 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, National Black Leadership Initiative on Cancer, is related to the priority area of cancer. 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, U.S. Government Printing Office, Washington, DC 20402 (telephone 202/783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by cancer centers, hospitals and clinics, institutions of higher education (public or private) such as colleges, universities, schools of public health, nursing, health science centers, and eligible agencies of the Federal Government. Applicant institutions should have substantial involvement with the black community, providing a range of health care, health education, and/or disease prevention services. Collaborative applications are encouraged. Among collaborators, one must be designated as the lead applicant and assume responsibility for conduct of the project. Foreign organizations are not eligible to apply, and applications from domestic organizations may not include international components. MECHANISM OF SUPPORT Administrative and funding support will be provided via the cooperative agreement (U01), an assistance mechanism in which substantial NCI scientific/programmatic involvement with the awardee is anticipated. Under the cooperative agreement, NCI's purpose is to support community-based activity by jointly cooperating with the award recipient in a partner role, but not to assume direction, prime responsibility, or a dominant role in the project. Details of responsibilities, relationships, and governance of the project that results from this RFA are discussed below under the section "Terms and Conditions of Award." The total project period for applications submitted in response to this RFA may not exceed four years. The anticipated start date for the award is September 1995. At this time, NCI has not determined whether, nor how, this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE Approximately $1.5 million in total costs (direct and indirect) will be committed each year for four years specifically to fund the one award that results from this RFA. RESEARCH OBJECTIVES Background In 1986, the National Cancer Advisory Board (NCAB) expressed concern about the heavy burden of cancer on the Black American community and how the tobacco and alcohol advertisements targeting that community serve to exacerbate the burden. To address their concern, the NCAB formed an ad hoc national planning committee comprised of Black American business, education, and health professionals to develop an operational plan for increasing community awareness about cancer. The work of that committee led to the formation of a conceptual organizational framework which was later named the National Black Leadership Initiative on Cancer and implemented in 1989. Since its inception, NBLIC has facilitated a wide variety of activities to promote cancer control and prevention among Black Americans. The program has developed strong networking relationships with national, state, local, grassroots, and special interest organizations across the United States. A major focus for NBLIC is the establishment of community-based cancer prevention and control coalitions. Project Rationale Data continue to show that Black Americans bear a disproportionate burden of cancer, marked by increasing mortality rates for many cancers in contrast to the trends among whites. The extent to which blacks experience higher cancer mortality is striking. Not only do blacks have higher mortality rates than whites, but these rates are also increasing faster. Further, mortality rates which are decreasing for whites are not decreasing as quickly for blacks and, for a few cancers, are still increasing, i.e., larynx, oral cavity, pancreas, colon and rectum, and leukemia. The age-adjusted incidence rate for all cancers and both sexes combined increased in both blacks and whites by about 22 percent between 1973 and 1991. However, the magnitude of the overall cancer incidence rate among blacks was nearly 8 percent higher than among whites in 1991. In 1991, the age adjusted incidence rate for all cancers combined was 405 per 100,000. Rates are highest in black men (598 per 100,000 and lowest in black women (334 per 100,000). In 1991, the age adjusted mortality rate for all cancers was 173 per 100,000. Mortality rates are highest in black men (317 per 100,000). Rates are lowest in white women (141 per 100,000). Five-year relative survival is higher among women than men and whites than blacks for all sites combined and all sites except lung and bronchus. Exclusion of lung and bronchus results in an almost 10 percentage point increase in survival for white and black men, and a 4 to 5 percentage point increase for white and black women, clearly illustrating the large impact of lung and bronchus on the cancer burden within the general population, especially among men. Improvements in survival since 1974-76 have been significant for all groups except black women although the amount of improvement is small. Black Americans have disproportionately larger numbers of blue-collar workers, possibly increasing their risk of certain occupationally-related cancers. Fewer Black Americans have adequate health insurance coverage, thereby decreasing the likelihood that they will have access to early detection methods or state-of-the-art treatment. Certain culturally-based factors, such as unhealthy dietary habits and negative attitudes toward health and health care, have been identified and linked to cancer within the Black American community. Ethnic and cultural differences involving dietary patterns, alcohol use, and sexual and reproductive behaviors can provide clues to factors involved in the development of cancer. Socioeconomic factors such as lack of health insurance or transportation can impede access to care, and lead to late diagnosis and poor survival. Objectives and Scope Recognizing that there are numerous health interventions being conducted in the black community by local and other federal funding agencies, this RFA will support activities that identify and fill gaps in current cancer prevention and control programs, and evaluate the efficacy of existing intervention strategies. Guided by the results of those activities, the award recipient develops and implements improved intervention strategies, more effective community program, and stronger cancer control coalitions. Measurable improvements are expected in knowledge, attitude, and behavior of Black Americans about the prevention and early detection of cancer. NBLIC is national in scope targeting Black American males and females of all ages. Applicants are strongly encouraged to propose a plan for restructuring NBLIC geographically given the wide distribution of Black Americans in the western and plains states and the dense populations of those in the southern states. The plan should include a description of an efficient organizational structure through which the project will be managed, and programmatic approaches developed for reaching Black Americans in urban, suburban, and rural settings. It is suggested that concepts such as community organizing, and community wellness be considered, among others, as possible models for expanding and enhancing NBLIC coalitions established during previous years and to build new ones. (See references) The NBLIC project will involve three overlapping phases. Planning and Development (Phase I); Program Implementation and Evaluation (Phase II); and, Data Analysis and Reporting (Phase III). Although technical assistance will be provided by NCI (see Terms of Cooperation, below), the awardee is responsible for carrying out all aspects of each phase. The specific elements of each phase may vary relative to the awardee's level of involvement with NBLIC. For example, during Phase I, a continuing awardee might be primarily concerned with project refinement and enhancement in lieu of the developmental measures that would dominate this phase for a new awardee. Nonetheless, the following will be generally applicable: A. Phase I: Planning and Development o Develop a comprehensive, strategic project plan with time schedules and milestones to address all key aspects of the project. The plan should address such things as: the identity of target communities, methods to identify and recruit organizations and local leaders, strategies to establish and maintain productive relationships with cancer-related groups, methods for communities to identify their cancer control needs and design activities to meet these needs, ways to ensure area-wide program support and visibility, strategies for disseminating project findings, plans to provide on and off-site technical assistance, and methods for quality assurance. o Develop and implement a program management plan that includes a description of the program structure, roles and responsibilities of key staff, and a communication system for the regular exchange of information and ideas between key staff members and local area leaders, organizations, and coalitions. o Develop a plan for the development and dissemination of program messages, materials, and products. This will include target groups, goals and objectives, methods of development, distribution, and evaluation. For example, public media campaigns and patient education materials may be planned in response to community-identified needs. o Develop a detailed evaluation plan that includes process, outcome, and cost-effectiveness measures. See "Phase II: Implementation and Evaluation" below. o Develop a long range plan for continued community activity and institutionalization of this outreach initiative after the expiration of the four-year cooperative agreement. The plan may include such things as obtaining in-kind contributions, fostering volunteerism, pursuing cost-containment techniques, and establishing affiliations with health care provider groups and non-profit organizations. B. Phase II: Implementation and Evaluation During the second phase of the project, beginning 2-12 months from award, implementation and evaluation of outreach activities will begin according to the program plans developed in Phase I. Progress towards planning, implementation, evaluation, and documentation will be measured by milestones. Coalitions and outreach activities will be monitored for quality and outcome effects. The development of consortia or coalitions to achieve the objectives of this RFA is encouraged. If a consortium or coalition is proposed, a clear delineation of roles and administrative procedures must be outlined in the application. If the budget request includes support for more than one unit, policies and procedures for financial and program management must be outlined in the application. A significant aim of NCI is to improve the overall national cancer prevention and control effort by creating cohesion among cancer programs it sponsors, and other public and private health organizations. To this end, applicants should strive to establish relationships with relevant cancer programs (e.g., cancer information programs, facilities providing cancer care, local components of national cancer-related organizations, and cancer or other incidence registries) in areas where they exist. 1. Project Evaluation The NCI will only support projects which have well-developed, comprehensive evaluation plans. The evaluation plan must be conceptually and procedurally integrated with the overall project. It must connect implementation and outcome and specify a time frame for conducting all evaluation activities. The evaluation plan must describe the selection and development of sound measures and instruments for data collection. The application must include detailed and clearly written descriptions of process and outcome evaluation. Examples of questions that the NBLIC evaluation design should reflect include the following: o Did NBLIC build and maintain effective coalitions? o What explains coalition effectiveness? o Did NBLIC achieve changes likely to lead to reduced cancer incidence and mortality? o What explains changes in NCI cancer prevention and control indicators? o What about NBLIC is replicable? It is anticipated that the awardee will formulate additional evaluative type questions and/or amend the above to better explain key facets of NBLIC project activity. 2. Process Evaluation Process evaluation facilitates the replication of effective projects. It consists of the periodic monitoring of project implementation to document what actually was being done and to facilitate project adjustments or corrections when needed over the course of the project. It involves the collection of both quantitative and qualitative data that permit a description of the formation and ongoing functions of community coalitions as well as the project as a whole. Process evaluation may include descriptions of the methods used to form structure, and maintain community coalitions; the breadth of coalition membership and the interaction patterns of organizations and individuals in coalitions (e.g., patterns of communication, conflict, conflict resolution, coordination, cooperation, and collaboration); methods used to inform and involve the community in cancer control outreach activities; ways used to sustain trust and credibility for the program, and program costs. Process evaluation may also include detailed descriptions of project activities and their tracking. 3. Outcome Evaluation Outcome evaluation consists of assessing whether the project was effective in meeting its objectives in ways that will lead to project goals. The design of the outcome evaluation and the resulting data should be based on clear and measurable indicators of progress toward project goals. The outcome evaluation design should be rigorous enough to result in valid conclusions concerning the effectiveness and replicability of the project. Baseline data pertaining to the target area are essential for a meaningful outcome evaluation. Proposed baseline data (e.g., cancer measures of the availability and utilization of cancer control services, cancer rates, tobacco use rates, and indicators of knowledge about the prevention and early detection of cancer) and methods for obtaining data must be provided. Additionally, plans for the periodic collection of the same information must be described. The importance of external resources and the likelihood of their availability should be estimated. While awardee researchers should obtain as much baseline data as possible in the process of the preparation of the cooperative agreement application, refinement and development of key elements can occur at the beginning of the project period. The PI funded under this cooperative agreement is responsible for collecting core data that are comparable across project sites. The definition of these data will be jointly decided by the Steering Committee during the first year of the project (see SPECIAL REQUIREMENTS, Terms of Cooperation). These data may include, but are not limited to: measures of coalition effectiveness; characteristics of coalitions and their numbers; descriptions of planned activities; changes in utilization of cancer control services; and, extent of media coverage and involvement. C. Phase III: Data Analysis and Reporting In conducting the analysis, researchers should consider features of the setting (e.g., geographic, social, economic, demographic, etc.) which may either facilitate or impede implementation of the project. In addition, recommendations should be made concerning the potential for generalization of the project to other rural settings. Although this phase will overlap certain periods of Phase II, it is anticipated that data collection, analysis, and reporting will be most intense during the last two years of the four-year award. This is also the period for special emphasis on the dissemination of program findings. The awardee institution retains custody and primary rights to the data consistent with current DHHS, PHS, and NIH policies. However, NCI will have access to all data and may periodically review the awardee's data management procedures. In addition to required annual progress reports, the awardee will provide semi-annual reports and additional information as requested by the NBLIC Program Director. A suggested format for these reports will be provided by the NBLIC Program Director. NCI program staff will review the progress of NBLIC through consideration of the annual reports, site visits, and reports from collaborative institutions/organizations. Special intermittent reports or additional information may be required for purposes involving programmatic expedience. Examples of information that should typically be included in the reports are the following: o Community Coalitions - List the number and composition of coalitions with a breakout of those established by NBLIC; list and describe coalition activities and results; list and describe community resources that are available to coalitions; list and describe the resources that may be needed and how these would be allocated and managed to enhance coalition activity. o Education, Health Advocacy and Research - Describe the level of involvement with health advocacy type activities (e.g., anti- tobacco/smoking campaigns, and cancer screening programs) and how the information disseminated by NBLIC staff parallels NCI endorsed research findings. o Cancer Survivor Support Groups - List the number and describe the types of such groups with a breakout of those established by NBLIC; describe the frequency and place of support group meetings; provide examples of agenda items or topics discussed and a brief profile of the leader(s); describe how these groups are supported by NBLIC. o Community Leadership - List the number of community leaders recruited, provide a profile of each, and describe the role each performs in furthering the project agenda. Reports should also describe any untoward effects of NBLIC activities and how these were/are/will be addressed or resolved. SPECIAL REQUIREMENTS Terms and Conditions of Award The following special Terms and Conditions of Award will be incorporated into the award statement and provided to the institutional official at the time of award. They are in addition to and not in lieu of otherwise applicable OMB administrative guidelines; HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grants Administration policies. The administrative and funding instrument to be used for this project will be a cooperative agreement (U01), an assistance mechanism in which substantial NCI scientific/programmatic involvement with the awardee is anticipated during performance of the activity. However, the awardee has the dominant role and prime responsibility for each activity and the project as a whole. The inability of the awardee to meet the performance requirements set forth in the Terms and Conditions of Award in the RFA, or significant changes in the level of performance, may result in an adjustment of funding, withholding of support, suspension or termination of award. A. Awardee Rights and Responsibilities o Plan, develop, implement, evaluate, and direct all aspects of the project. o Publish project results during Phase III. o Define the role and responsibilities of the NBLIC Steering Committee, select its members and provide funds for their travel and appropriate meeting-related expenses. o Apprise the NCI Program Director of plans to develop printed materials and media messages intended for programmatic purposes. o In addition to required annual progress reports, provide semi- annual reports and additional information as requested by the NBLIC Program Director. o Collect, analyze, publish, and present data and program findings; retain custody of and have primary rights to the data developed under this award subject to Government rights of access consistent with current HHS, PHS, and NIH policies. o Ensure the representation of appropriate NBLIC project staff at key meetings. o Develop a long-range plan for possible continued community activity and institutionalization of NBLIC after expiration of the four-year cooperative agreement. The plan may include such things as obtaining in-kind contributions, fostering volunteerism, pursuing cost-containment techniques, and establishing affiliations with health care provider groups and non-profit organizations. B. NCI Program Director Responsibilities o Provide assistance to the awardee regarding the quality and type of data to be used and its potential value to the project, and shall periodically review the use of such data and assist in determining further use. o Assist the awardee with planning project activities and establishing priorities; assist in establishing and maintaining effective communication channels. o Confer with the awardee regarding staffing needs; advise and assist in the selection of key staff; may approve or disapprove key personnel. o Serve as a member of the NBLIC Steering Committee and report to NCI. o Assist in recruiting specialized technical assistance that is deemed essential to the development and distribution of culturally competent program communication messages and materials. o Assist in publishing data findings and process activities; participate in writing and preparing publications in accordance with NIH staff publication policies; retain authority to approve publications and printing costs exceeding $25,000 for a single publication. o Coordinate special meetings to address NCI priority issues. C. Collaborative Responsibilities A NBLIC Steering Committee, composed of the Principal Investigator and the awardee's NBLIC Project Manager, NCI, NBLIC Program Director, and community leaders such as those currently serving as NBLIC regional chairpersons, will be established to provide guidance and support for program activities and to identify project-wide needs and resources. The committee will select a chairperson from among its ranks other than the NCI member. As needed, the NBLIC Steering Committee may establish subcommittees, such as a data and evaluation subcommittee, to focus on special issues. D. Arbitration Any disagreement that may arise on programmatic matters (within the scope of the award), between the award recipient and NCI may be brought to arbitration. An arbitration panel will be composed of three members -- one selected by the project's advisory committee (with the NCI Program Director not voting) or by the awardee in the event of an individual disagreement, a second member selected by the NCI Program Director, and the third member selected by the two prior selected members. This special arbitration procedure in no way affect the awardee's right to appeal an adverse action that is appealable in accordance with PHS regulations at 42 CFR part 50, subpart D and HHS regulation at 45 CFR part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the National Institutes of Health (NIH) that women and members of minority groups and their subpopulations 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 new provisions that are substantially different from the 1990 policies. Due to the nature of this solicitation, the requirement for inclusion of minorities is satisfied. Applicants must still describe the proposed population, including gender composition operation and outreach plans. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513) to correct typesetting errors in the earlier publication, 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 program staff or contact person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 3, 1995, a letter of intent that includes a descriptive title of the proposed project, name, address, and telephone number of the principal investigator, identities of other key personnel and participating institutions, and number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows NCI 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 Frank E. Jackson, NBLIC Program Director, at the address provided under INQUIRIES. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this award. These forms are available at most local institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone 301/584-7248. 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, typed original of the application (without appendices), including the Checklist, and three signed, exact, clear, and single-sided photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 Rockville, MD 20852 It is important to send these copies at the same time that the original and three copies are sent to DRG; otherwise, the NCI cannot guarantee that the applications will be reviewed in competition with other applications received on or before the designated receipt date. Applications must be received by April 27, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must include an introduction addressing the previous critique. Include the following additional information on the application form PHS 398 continuation pages. o Document the applicant institution's experience with community- based health interventions, and describe the management systems that were effective in organizing the effort, monitoring project resources, and working with coalitions. o Attest to the adequacy and availability of facilities to be used for the project, such as office space and equipment. o Describe key personnel and their proposed duties as well as their current duties with the applicant institution. The level of effort of personnel on this project should reflect the commitment of the individual and the applicant institution to ensuring organizational efficiency and maximum resource utilization. Applicants should include an appropriately justified budget for each 12 month segment for a total of four years of funding, and describe the fiscal plan that will provide support for coalition activities, (e.g., meetings, mailings, programs, etc.). Travel estimates for the four year project period should include up to four meetings for the Steering Committee during the first year and one annual meeting for each group thereafter in Bethesda, MD. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants and responsiveness by the NCI. Incomplete and non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCI in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. The second level of review will be performed by the National Cancer Advisory Board. This Board considers the special needs of NCI and the priorities of the National Cancer Program. Review Criteria Applications will be judged primarily on evidence of an understanding of the Black American community and its cancer control needs; the ability to access and obtain participation of the community, recruit community leaders, establish coalitions, and collaborate with other organizations; qualifications of the investigators, including community outreach experience, cultural competence, and cancer control and communications expertise; capability to perform the work proposed; and a demonstrated willingness to work together with collaborating entities and NCI staff. The following criteria will be used in the review: o Comprehensiveness, feasibility, and consistency of the proposed project plan with the goals and objectives of the RFA, and the extent to which the application demonstrates originality and an understanding of cancer control outreach activities as well as community coalition development; o Rationale for selection of the targeted geographic area and documentation of its cancer control needs including cancer-related risk factors, access and utilization of health care services, and cancer rates; o Adequacy and soundness of the staffing and project management plans, including evidence of the capability, experience, and qualifications of the awardee and cooperating institution's technical staffs to implement the project successfully and a good overall balance of the program team in relation to the objectives of the project; o Appropriateness of the implementation plan and the extent to which it demonstrates sensitivity to cultural and socioeconomic factors in the community, including evidence that these factors are significant targets of inclusion in community coalitions; o Evidence of program linkages to existing relevant federal, state, and local cancer control plans and activities in target communities, as well as a strategy for improving existing plans and stimulating their implementation; o Adequacy, appropriateness, feasibility, and comprehensiveness of the evaluation plan, including sufficient allocation of resources; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o Feasibility of the project within the resources and time frames proposed; appropriateness of the proposed budget and duration in relation to the proposed initiative; and inclusion of specific written agreements with cooperating institutions, including those agencies that may be providing services and/or the settings for these services. AWARD CRITERIA The anticipated award date is September 1995. Applicants will compete for funding based on the quality and merit of the proposed outreach program as determined by peer review. Cooperative agreement applications recommended by the National Cancer Advisory Board will be considered for award based upon (a) scientific and technical merit; (b) program balance, including in this instance, sufficient compatibility of features to make a successful collaborative program a reasonable likelihood; and (c) availability of funds. As with research grants, interim and terminal progress reports must be submitted to the NCI in accordance with the current PHS Grants Policy Statement. The interim progress reports will be a part of the noncompeting continuation application and should include the following information: (a) a brief statement and critique of progress toward achieving originally stated objectives; (b) a description or listing of related issues, positive or negative, considered to be significant by the awardee, and (c) plans for the next funding period. Terminal progress reports must be submitted within 90 days after the end of the project and should include items (a) and (b) above. INQUIRIES 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: Frank E. Jackson Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 240D Bethesda, MD 20892 Telephone: (301) 496-8589 FAX: (301) 496-8675 Email: Direct inquiries regarding fiscal matters to: Catherine E. Blount Grants Management Officer National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20852 Telephone: (301) 496-7800 Ext. 262 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78- 410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant 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. References 1. National Cancer Institute, SEER Cancer Statistics Review 1973-1991, NIH Publication No. 94-2789 2. Gail MH: A Review and Critique of Some Models Used in Competing Risk Analysis, Biometrics 31: 209-222, 1975. 3. National Center for Health Statistics. Health, United States, 1993, DHHS Publication No. (PHS) 94-1232. Washington, DC: U.S. Department of Health and Human Services, 1990. 4. Bennett, C.E.: The Black Population in the United States: March 1992, Bureau of the Census, U.S. Department of Commerce 5. Hunkeler, E.F., et al.: Richmond Quits Smoking: A Minority Community Fights for Health, Health Promotion at the Community Level, Sage Publications, Newburg Park, CA, 1990 6. Jenkins, S.: Community Wellness: A Group Empowerment Model For Rural America, Journal of Health Care for the Poor and Underserved, Vol. 1, No.4, Spring 1991 From owner-sci-resources@net.bio.net Fri Feb 03 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-025 - V24(04) 02/03/95 Date: 3 Feb 1995 22:13:35 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 282 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3gv5uf$p6j@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95025 PA-95-025 P1O1 *************************************** APOPTOSIS MODULATORS FOR TREATMENT OF AIDS-RELATED CANCERS NIH GUIDE, Volume 24, Number 4, February 3, 1995 PA NUMBER: PA-95-025 P.T. 34; K.W. 0715008, 0715035, 1002004 National Cancer Institute Application Receipt Date: May 1, 1995 PURPOSE The purpose of this Program Announcement is to encourage investigators to discover modulators of the apoptotic process with the intent of developing new therapies for AIDS-related malignancies. 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 Program Announcement (PA), Apoptosis Modulators for Treatment of AIDS-Related Cancers, is related to the priority area of human immunodeficiency virus/AIDS and cancer. 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, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications may be submitted from one institution or may include arrangements with several institutions, if appropriate. Applications involving minority institutions are encouraged. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Support for this PA will be the investigator-initiated research project grant (R01), FIRST (R29) award, or the Interactive Research Project Grants (IRPG) mechanisms. If an IPRG is proposed, it must consist of a minimum of two independent applications (see PA-94-086, NIH Guide for Grants and Contracts, Volume 23, Number 28, July 29, 1994). An IRPG may consist of a combination of R01s and R29s or R01s only, but may not consist solely of R29 applications. An IRPG may also contain shared interactive resources (Cores), which must serve at least two of the research projects in order to facilitate achievement of the Group's common research goals. Collaborative arrangements involving more than one institution are especially encouraged, including participation of the pharmaceutical industry where appropriate. FUNDS AVAILABLE The NCI has set aside approximately $1.0 million total costs in Fiscal Year 1995 for the first year of funding for support of applications received in response to this PA. The level of support is dependent on the receipt of a sufficient number and diversity of applications of high scientific merit and the availability of funds. Because the nature and scope of the research proposed in response to the PA may vary, the sizes of awards will vary. It is expected that four or five awards will be made. RESEARCH OBJECTIVES Background Human immunodeficiency virus (HIV) infection causes a pronounced decrease in CD4+ T helper cells resulting in loss of immune function. AIDS patients have an unusually large incidence of highly aggressive malignancies related to their attenuated immune functions. New and more effective methods to treat AIDS associated cancers are badly needed. Recent evidence suggests that apoptosis is an important component of cancer therapy. The intrinsic killing power of drugs or radiation may be less important than the ability of these agents to stimulate tumor cells to kill themselves. Apoptosis may also be relevant to some aspects of drug resistance and may explain why tumor cells are more sensitive to cell killing than are normal cells. Exploitation of this concept of tumor cell death for the development of new and more effective therapies provides an exciting and potentially fruitful challenge. Objectives and scope Apoptosis is a topic of considerable research interest. Numerous research projects have been undertaken to delineate the mechanisms and molecular factors that regulate the process. As a result of these efforts, an understanding of apoptosis encompassing a broad range of cellular mechanisms is emerging. The goal of this PA is the exploitation of these exciting advances in the understanding of the mechanism of apoptosis for discovery of modulators of the apoptotic process with the intent of developing new therapies for AIDS-related malignancies. Applications focused on exploitation of current knowledge of apoptosis for the discovery of agents that modulate the process are encouraged. Applications designed solely to understand the basic principles of apoptosis are not encouraged as part of this initiative. Examples of research topics include, but are not limited to: o Altering gene expression or activity of gene products which regulate apoptosis,i.e., p53, c-myc, bcl-2, or bax. o DNA repair mechanisms. o Stimulation of oxidative damage or stress. o Cell signalling mechanisms which influence apoptosis. o Development of in vitro and in vivo model systems for discovery of apoptotic modulators. Applications could include biological evaluation of active agents using these models. 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 subpopulations 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. 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, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used. Forms are available at most institutional offices of sponsored research or 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. Receipt date for applications for this AIDS-related research PA is May 1, 1995. The title and number of the PA must be typed in Section 2a of the face page of the application. FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. If an IRPG is proposed, each application must be identified along with the number of the PA and the phrase "Investigator-initiated IRPG". All R01 or R29 applications constituting the proposed IRPG cohort must be submitted in a single package, whether or not the applications arise from the same institutions. For detailed instructions for preparations and submission of IRPG applications, refer to PA-94-086, NIH Guide for Grants and Contracts, Volume 23, Number 28, July 29, 1994. A signed, typewritten original of the application and five legible copies must be sent or delivered in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific/technical review, the applications will receive a second-level review by an appropriate National Advisory Council/Board. Applications that are complete and responsive to the program announcement will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA For Fiscal Year 1995, the NCI has set aside $1 million for this initiative. However, applications will compete for funding with all other approved applications, and funding decisions will be based on scientific merit as determined by peer review and programmatic priorities. INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. George S. Johnson Division of Cancer Treatment National Cancer Institute Executive Plaza, North, Room 832 Bethesda, MD 20892-7450 Telephone: (301) 496-8783 FAX: (301) 496-8333 Email: meadt@dctod.nci.nih.gov Direct inquiries regarding fiscal matters to: Ms. Marci Bollt Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 243 MSC-7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 242 FAX: (301) 496-8601 Email: bolltm@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.395, Cancer Treatment Research. Awards are made under authorization of HHS policies and grant regulations. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. From owner-sci-resources@net.bio.net Fri Feb 03 22:00:00 1995 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-95-019 - V24(04) 02/03/95 Date: 3 Feb 1995 22:13:23 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 370 Sender: biohelp@net.bio.net Approved: biosci-moderator@net.bio.net Distribution: world Message-ID: <3gv5u3$p5q@net.bio.net> NNTP-Posting-Host: net.bio.net $$XID RFA PA95019 PA-95-019 P1O1 *************************************** H. PYLORI: BASIC, PRE-CLINICAL, AND CLINICAL RESEARCH NIH GUIDE, Volume 24, Number 4, February 3, 1995 PA NUMBER: PA-95-019 P.T. 34; K.W. 0715125, 0755020, 0740074, 0710070 National Institute of Allergy and Infectious Diseases National Institute of Diabetes, Digestive and Kidney Diseases Application Receipt Dates: June 1, and October 1, 1995 and February 1, 1996 THIS IS A REPUBLICATION OF PA-95-019, PUBLISHED IN THE NIH GUIDE, VOL. 24, NO. 1, JANUARY 13, 1995. DISREGARD PREVIOUS VERSIONS. PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite submission of investigator-initiated research applications for support of research on the definition of the natural history of infection, animal models, protective immune responses to infection, virulence determinants, bacterial genetics, and antibiotic resistance to Helicobacter pylori. This bacterium is known to be associated with chronic gastritis, duodenal and gastric ulcer disease, and possibly with certain malignancies of the stomach. The development of vaccines against this organism is also of interest to the NIAID. The mechanisms of support will be the individual research project grant (R01) and the FIRST (R29) award. 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 program announcement, H. Pylori: Basic, Pre-Clinical and Clinical Research, 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 20402-0325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) award (R29). MECHANISM OF SUPPORT The mechanisms of support will be the individual research project grant (R01) and the FIRST (R29) award. The total project period for an application submitted in response to this program announcement may not exceed five years; a foreign application may not request more than three years of support. FUNDS AVAILABLE The estimated NIAID funds available for the total (direct and indirect) first-year costs of awards made under this PA will be $1,000,000. In Fiscal Year 1996, the NIAID plans to fund four to five R01 and/or R29 grants. 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 program announcement are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. The NIDDK has an interest in Helicobacter pylori research, but does not have set-aside funds for the purpose of this PA. Applications received in response to this PA that are assigned to NIDDK or other PHS funding components will compete with other applications for funding. New applications submitted for the June 1 and October 1, 1995 and February 1, 1996 receipt dates will be eligible for funding under this program announcement. Competing continuation applications for already funded projects will NOT be eligible for award from NIAID under this program announcement. RESEARCH OBJECTIVES Background In 1983, a spiral shaped, urease producing, Gram negative bacterium, Helicobacter pylori, was identified in the stomachs of some individuals. Since then, there has been increasing evidence for its association with active and chronic gastritis, peptic ulcers, and duodenal ulcers. Effective treatment of the infection with antibiotics eliminates ulcer recurrences in more than 90 percent of cases. An epidemiologic relationship between atrophic gastritis, which develops in a small percentage of those infected with H. pylori, and gastric malignancies has also been noted. H. pylori colonizes the gastric mucosa of greater than 30 percent of persons in the U.S. and more frequently in African American, Hispanic, and socioeconomically disadvantaged populations in this country. In some developing countries, it is found in almost 100 percent of the population. Non-ulcer dyspepsia (NUD) and gastric and duodenal ulcer disease, are among the most common human ailments of the upper GI tract requiring medical attention. An estimated 10 percent of people in the United States will develop peptic ulcer disease, a chronic inflammatory condition of the stomach and duodenum, sometime in their lifetime. It is estimated that there are 300,000 new cases, 3.2 million recurrences, and 3,000 deaths due to duodenal ulcer disease each year in the U.S. NUD affects even greater numbers of individuals, but a causal relationship between NUD and H. pylori has not been definitively established to date. Defining this relationship, and identifying even a subset of NUD patients, would facilitate the prescription of appropriate antibiotic therapy for those individuals. A recent Consensus Conference sponsored by NIDDK, NIAID, and the NIH Office of Medical Applications of Research recommended that patients presenting with duodenal or gastric ulcers, who were also seropositive for H. pylori, be treated with antimicrobial triple therapy to eradicate the organism. The Panel recommended that basic research should be conducted in order to generate much needed data on the biology of this organism. The development of an effective preventive strategy, including the development of a vaccine should also be pursued when sufficient information on pathogenesis is available. This initiative will focus on these basic issues, including definition of the natural history of infection, animal models, protective immune responses to infection, virulence determinants, bacterial genetics, and antibiotic resistance. It is known that a significant number (approximately 10 percent) of children under the age of 10 in the U.S. are seropositive for H. pylori. The source of infection, modes of transmission, identification of risk factors, and the consequence of this infection on the health of the young are not known, and are of special interest to the NIAID in the context of this program announcement. Research Objectives and Experimental Approaches Well-designed basic, pre-clinical and clinical studies are needed to provide a better understanding of H. pylori biology and pathogenesis so that effective intervention strategies can be designed. Topics of interest to the NIAID include, but are not limited to: o development or use of animals that can be infected with human isolates of H. pylori and that serve as models for stages of the human disease and are amenable to evaluation of prophylactic and therapeutic strategies; o identification of virulence factors of the organism, effect of deletion of virulence factor genes on pathogenesis; o biomarkers (