Vol. 18, No. 4, February 10, 1989 NOTICES REFERENCE LETTERS FOR NINDS CLINICAL INVESTIGATOR DEVELOPMENT AWARD APPLICATIONS .....................................(84/114)............. 1 National Institute of Neurological Disorders and Stroke Index: NEUROLOGICAL DISORDERS, STROKE DATED ANNOUNCEMENTS (RFPs AND RFAs) CLINICAL TRIALS OF ANTICANCER AGENTS (PHASE II) (RFP) ..(120/181)............ 1 National Cancer Institute Index: CANCER CLINICAL TRIALS OF ANTICANCER AGENTS (PHASE I) (RFP) ...(184/247)............ 2 National Cancer Institute Index: CANCER EVALUATION OF THE SAFETY AND IMMUNOGENICITY OF AN INVESTIGATIONAL VACCINE (RFP) ............................(250/284).......... 3 National Institute of Child Health and Human Development Index: CHILD HEALTH, HUMAN DEVELOPMENT CENTER FOR RESEARCH AND KNOWLEDGE DISSEMINATION ON SELF-HELP MENTAL HEALTH SERVICES (RFA) ............................(287/317)........... 3 National Institute of Mental Health Index: MENTAL HEALTH COLLABORATIVE STUDIES FOR DIAGNOSTIC CENTERS FOR PSYCHIATRIC LINKAGE STUDIES (RFA) ...................................(321/364)........... 4 National Institute of Mental Health Index: MENTAL HEALTH RESEARCH DEMONSTRATION GRANTS ON DRUG TREATMENT WITH PUBLIC SERVICE OR FOR PREGNANT WOMEN (RFA) .....................(367/451)........... 4 National Institute on Drug Abuse Index: DRUG ABUSE COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK (RFA) ...(454/603)..... 5 National Institute of Child Health and Human Development (1044/1727) Index: CHILD HEALTH, HUMAN DEVELOPMENT PUBLIC-ACADEMIC FELLOWSHIP PROGRAM IN MENTAL HEALTH SERVICES RESEARCH (RFA) ...............................................(606/647)...... 7 National Institute of Mental Health Index: MENTAL HEALTH RESEARCH ON SERVICES FOR PERSONS WITH MENTAL DISORDERS THAT CO-OCCUR WITH ALCOHOL AND/OR DRUG ABUSE (RFA) ................(650/689)...... 8 Alcohol, Drug Abuse, and Mental Health Administration Index: ALCOHOL, DRUG ABUSE, MENTAL HEALTH CANCER PREVENTION AND CONTROL RESEARCH SMALL GRANTS PROGRAM (RFA) ........... 8 National Cancer Institute (692/833, 1730/2248) Index: CANCER ONGOING PROGRAM ANNOUNCEMENTS RESEARCH ON CHILDREN OF ALCOHOLICS .....................(839/905)............10 National Institute on Alcohol Abuse and Alcoholism Index: ALCOHOL ABUSE, ALCOHOLISM ERRATA ADAMHA SCIENTIST DEVELOPMENT AWARD AND ADAMHA SCIENTIST DEVELOPMENT AWARD FOR CLINICIANS .......................(911/949)...........11 Alcohol, Drug Abuse, and Mental Health Administration Index: ALCOHOL, DRUG ABUSE, MENTAL HEALTH DEVELOPMENT OF SMALL ANIMALS EXPRESSING HUMAN IMMUNODEFICIENCY VIRUS GENES AS MODELS FOR THERAPY (RFA) ................(961/974)............12 National Institute of Allergy and Infectious Diseases Index: ALLERGY, INFECTIOUS DISEASES NOTICES REFERENCE LETTERS FOR NINDS CLINICAL INVESTIGATOR DEVELOPMENT AWARD APPLICATIONS P.T. 34; K.W. 1014006 National Institute of Neurological Disorders and Stroke Applications for the Clinical Investigator Development Award (CIDA) of the National Institute of Neurological Disorders and Stroke (NINDS) must include three letters of reference: two from referees and one from the sponsor. To expedite the review process, the NINDS requires that applicants include these reference letters with their submitted application package, effective with applications submitted for the June 1, 1989, deadline. CIDA applicants should request the reference letters from their referees and sponsor well in advance of the application submission deadline, and ask them to prepare the references and return them to the applicant in sealed envelopes in time to be included with the application package. To protect the utility and confidentiality of the reference letters, applicants are asked not to open the sealed envelopes. Questions concerning the CIDA program may be directed to: Mr. Edward M. Donohue Deputy Director Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1016 7550 Wisconsin Avenue Bethesda, Maryland 20892 Telephone: (301) 496-4188 DATED ANNOUNCEMENTS (RFPs AND RFAs) CLINICAL TRIALS OF ANTICANCER AGENTS (PHASE II) RFP NO. NCI-CM-07309-74 P.T. 34; K.W. 0755015, 0745005, 0740020, 0715035 National Cancer Institute The Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment (DCT), National Cancer Institute (NCI), is seeking organizations with the capabilities and facilities to provide a resource for the conduct of early and high priority Phase II trials. Specifically, the organizations shall: a) test new agents which have just completed Phase I trials, to confirm that the dose and schedule chosen can be safely given in subsequent Phase II trials; b) determine the antitumor activity of existing antitumor agents which can be administered in significantly higher doses when used with colony-stimulating factors or other factors which modulate toxicity or antitumor activity; c) determine the antitumor activity of combinations of antitumor agents and modalities; d) evaluate laboratory parameters which may correlate with or predict for response; and e) determine the spectrum of antitumor activity for new agents in selected human cancers. While the contract will permit occasional Phase II trials, major emphasis shall be on early Phase II studies which are pivotal for drug development and require rapid initiation, completion and data reporting. All patients for these studies must be treated at the offeror's own institution. Offerors who propose must demonstrate the institution's ability to accrue at least 200 fully evaluable patients per year and complete, on average, over the length of the contract, at least seven (7) Phase II trials a year. The minimum requirements for each tumor type shall be dictated by the particular protocols which are approved for each Contractor. For any proposed trial, the Contractor shall be required to document the institution's ability to accrue the required number of patients within a reasonable time period. The proposed acquisition is a recompetition of four (4) existing contracts currently held by the following: Vol. 18, No. 4, February 10, 1989 - Page 1 N01-CM-57732 Memorial Sloan Kettering N01-CM-57733 Mayo Foundation N01-CM-57734 University of Maryland N01-CM-57739 University of Texas - M.D.Anderson It is anticipated that four (4) awards will be made and that the resulting contracts will be awarded on an incrementally funded basis for a period of 84 months. RFP NCI-CM-07309-74 will be available on or about February 22, 1989, with a due date for receipt of proposals of April 22, 1989. Copies of the RFP may be obtained by sending a written request to: Odessa S. Henderson Contract Specialist Treatment Contracts Section National Cancer Institute Executive Plaza South, Room 603 Bethesda, Maryland 20892 Telephone: (301) 496-8620 CLINICAL TRIALS OF ANTICANCER AGENTS (PHASE I) RFP AVAILABLE: NCI-CM-07301-74 P.T. 34; K.W. 0755015, 0745005, 0740020, 0715035 National Cancer Institute The Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer Treatment (DCT), National Cancer Institute (NCI), is seeking organizations with the capabilities and facilities to provide Phase I and Clinical Pharmacokinetic evaluation of investigational new drugs which are developed through the DCT Drug Development Program and are sponsored to the Food and Drug Administration (FDA) under an Investigational New Drug Application (IND) held by DCT. Specifically, the organizations shall perform studies to define the acute toxicities of new anticancer agents in patients with advanced cancer; redefine the acute toxicities and pharmacokinetics of anticancer agents administered in combination with agents to modulate toxicity or antitumor effort; provide information on the pharmacokinetic characteristics (absorption, distribution, metabolism, and elimination) and pharmacodynamics of selected antitumor agents; and determine a treatment regimen suitable for evaluation of antitumor activity in Phase II trials. All patients for these studies must be treated at the offeror's own institution. Offerors who propose must demonstrate an adequate patient accrual rate within the offeror's institution to provide at least 50 fully evaluable patients per year. It is estimated that the contractor shall perform at least three Phase I trials per year. The Contractor shall perform at least two pharmacokinetic studies per year on the compounds evaluated in the Phase I trials. The proposed acquisition is a recompetition of six existing contracts currently held by the following: N01-CM-57732 Memorial Sloan Kettering N01-CM-57733 Mayo Foundation N01-CM-57734 University of Maryland N01-CM-57735 University of Wisconsin N01-CM-57736 Ohio State University N01-CM-57737 University of Texas - San Antonio N01-CM-57738 Johns Hopkins University N01-CM-57739 University of Texas - M.D.Anderson It is anticipated that eight (8) awards will be made and that the resulting contracts will be awarded on an incrementally funded basis for a period of 66 months. RFP NCI-CM-07301-74 will be available on or about February 22, 1989, with a due date for receipt of proposals of April 22, 1989. Copies of the RFP may be obtained by sending a written request to: Vol. 18, No. 4, February 10, 1989 - Page 2 Odessa S. Henderson Contract Specialist Treatment Contracts Section National Cancer Institute Executive Plaza South, Room 603 Bethesda, Maryland 20892 Telephone: (301) 496-8620 EVALUATION OF THE SAFETY AND IMMUNOGENICITY OF AN INVESTIGATIONAL VACCINE RFP AVAILABLE: NICHD-IRP-89-13 P.T. 34; K.W. 0755015, 0740075 National Institute of Child Health and Human Development The National Institute of Child Health and Human Development (NICHD) is proposing a study for the evaluation of the safety, immunogenicity and effectiveness of a new vaccine developed by the NICHD scientists. The study will determine whether the vaccine prevents meningitis and other invasive diseases due to Haemophilus influenzae type b. The design will be a double-blinded randomized controlled study of a newly developed vaccine. The Offeror shall have access to a population of 2-month-old infants, 5500 per year for 2 years, under the care of private practitioners who have the knowledge and willingness to participate in a community with a program designed to test the effectiveness of the new vaccine. The Offeror shall have a position of authority and responsibility within a community that has had documented history of the number of cases of its Haemophilus influenzae type b meningitis over a 10-year period, to establish the consistency of disease occurrence and to evaluate the effectiveness of this vaccine so that a statistically valid assessment of its effectiveness can be established. The Request for Proposals, RFP/NICHD/IRP-89-13, will be issued on or about February 1, 1989, with responses due on March 21, 1989. Copies of the RFP may be obtained be sending a written request to: Mrs. Jennifer Jones Contracts Management Section Office of Grants and Contracts National Institute of Child Health and Human Development Executive Plaza North, Room 515 6130 Executive Boulevard Bethesda, Maryland 20892 CENTER FOR RESEARCH AND KNOWLEDGE DISSEMINATION ON SELF-HELP MENTAL HEALTH SERVICES RFA AVAILABLE: MH-89-15 P.T. 04; K.W. 1004017, 0403004 National Institute of Mental Health Application Receipt Date: May 4, 1989 The National Institute of Mental Health announces the availability of support for one Center for Research and Knowledge Dissemination on Self-Help Mental Health Services. The purpose of this Center will be to provide a stimulating and productive environment in which experienced health services, clinical, and sociocultural researchers can interact and work with mental health consumers, consumer representatives, services policymakers, and mental health service advocates on self-help aspects of mental health. Eligible applicants are any non-profit or for-profit research organizations. Applications can be made for a maximum amount of $250,000 (total, including direct and indirect costs) per annum, and for a maximum period of 5 years. NIMH will accept applications under the single receipt date of May 4, 1989. Potential applicants wishing further information should contact: Charles Windle, Ph.D. Biometry and Clinical Applications Branch, NIMH 5600 Fishers Lane, Room 18C-14 Rockville, Maryland 20857 Telephone: (301) 443-4233 Vol. 18, No. 4, February 10, 1989 - Page 3 COLLABORATIVE STUDIES FOR DIAGNOSTIC CENTERS FOR PSYCHIATRIC LINKAGE STUDIES RFA AVAILABLE: MH-89-05 P.T. 34; K.W. 0785185, 0715177, 1715180, 0745020 National Institute of Mental Health Application Receipt Date: May 4, 1989 The National Institute of Mental Health (NIMH) seeks applications for cooperative agreements from institutions to participate with NIMH in a multi-center genetic linkage program to study the genetics of schizophrenia, bipolar disorder, and Alzheimer's disease. The primary goal is to establish a national resource of immortalized cell lines from reliably diagnosed probands with the above disorders and their key relatives. Applicants should request cooperative agreement support for 5 years. The maximum amount of support that may be requested is $140,000 per year in direct costs. It is anticipated that 9 awards will be made in fiscal year 1989. The initial receipt date for applications is May 4, 1989. For consultation concerning submission of applications, potential applicants should contact NIMH staff listed below: S. Charles Schulz, M.D. Chief, Schizophrenia Research Branch Division of Clinical Research, NIMH Room 10C-06, Parklawn Building 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-3524 or Mary C. Blehar, Ph.D. Head, Clinical Biological Studies of Mood Disorders Program Division of Clinical Research, NIMH Room 10C-24, Parklawn Building 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-4524 RESEARCH DEMONSTRATION GRANTS ON DRUG TREATMENT WITH PUBLIC SERVICE OR FOR PREGNANT WOMEN RFA AVAILABLE: DA-89-03 P.T. 34; K.W. 0404009, 0775020, 0403004 National Institute on Drug Abuse Application Receipt Date: April 24, 1989 Research Areas of Interest New applications for research demonstration projects are solicited in two areas of interest: 1) the feasibility and efficacy of programs providing drug abuse treatment and vocational training in exchange for public service; and 2) the effectiveness of providing maternal care in drug abuse treatment to pregnant women, post partum women, and their infants. Applicants are not expected to combine both areas of interest into a single study. Research demonstration projects may include the creation of new treatment slots or may augment existing slots by providing new services needed for research purposes. Program for Treatment and Vocational Training in Exchange for Public Service Many drug abuse treatment programs now require patients to pay some portion of treatment costs. Since drug abusing individuals seeking treatment may often have financial and employment problems, this requirement may impose a barrier for many in need of drug treatment. Also, many of those needing treatment lack appropriate job skills and need vocational training. An alternative to Vol. 18, No. 4, February 10, 1989 - Page 4 requiring direct or third-party payment is to allow individuals to exchange public service for treatment coupled with appropriate vocational training. The National Institute on Drug Abuse (NIDA) will support research demonstration studies to investigate the feasibility and efficacy of programs providing drug abuse treatment and vocational training in exchange for public service. The public service should have practical significance for the drug abuser and the community, and ideally would integrate the drug abuser's vocational training, aptitude, and ability. Program for Drug Abuse Treatment Services to Pregnant Women, Post Partum Women, and their Infants The potential consequences of maternal drug abuse to offspring include retarded fetal growth, premature delivery, low birth weight, drug-specific neonatal withdrawal syndromes, and abnormal environmental responses. Elimination or reduction in the maternal use of illicit drugs as a result of enrolling and retaining drug-abusing pregnant and post-partum women in drug abuse treatment may forestall such consequences, and providing medical care to these women should provide additional benefits. Although drug abusing childbearing women may be difficult to locate, enroll, and maintain in traditional drug abuse treatment programs, clinical studies have shown the importance of providing a continuum of care through therapeutic programs, comprehensive supportive services, and medical treatment. NIDA will support controlled clinical studies to investigate the benefits of programs providing drug abuse treatment and maternal care services for drug abusing pregnant and post partum women and their infants. Of particular interest are research projects directed toward comprehensive programs that provide a continuum of prenatal and postnatal care, including detoxification or methadone maintenance, psychotherapy, social support activities, and general followup medical care for mother and infant. For a copy of complete RFA announcement contact: Mr. Desmond McLearen Grants Management Branch, OPRM NIDA, Room 10-25 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-6710 For more detailed program information contact: Dr. Jack Blaine Treatment Research Branch Division of Clinical Research 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-4060 COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK RFA AVAILABLE: 89-HD-04 P.T. 34; K.W. 0715167, 0785135, 0413002, 0785035 National Institute of Child Health and Human Development Application Receipt Date: July 17, 1989 The Reproductive Sciences Branch (RSB) of the Center for Population Research (CPR) of the National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the assistance of NICHD under Cooperative Agreements in multicenter cooperative clinical studies investigating problems in adult reproductive medicine, including reproductive endocrinology, obstetrics and gynecology, and andrology. BACKGROUND The area of reproductive health care has, in some instances, put into use diagnostic and therapeutic practices without sufficiently rigorous controlled evaluation of their effectiveness. With the present demographic trend to delayed childbearing, there is a greater need than ever to be able to identify reproductive disorders quickly and accurately, to describe subpopulations of Vol. 18, No. 4, February 10, 1989 - Page 5 infertility and subfertility, and to be able to provide the most appropriate therapies with the least possible delay. RESEARCH GOALS AND SCOPE The purpose of this RFA is to establish a Network of Clinical Reproductive Medicine Units (RMUs) and a Data Coordinating Center (DCC), with the cooperation of NICHD staff, to conduct research in high priority areas of reproductive medicine. The Network will identify topics of high priority, design appropriate protocols, implement the protocols, and analyze and disseminate the results. It is anticipated that the program will consist of four phases (duration of phases are estimates only): Phase 1 (6 months) Identification of issues of importance and ranking according to public need. Phase 2 (6 months) Design of diagnostic and treatment protocols to be accepted in common by all participating organizations. Phase 3 (48 months) Institution of clinical protocols, data collection, data transfer. Phase 4 (40 months) Planning pertaining to study termination, new protocols, and future needs. This phase will begin six months after Phase 3 has started. It is anticipated that six RMUs and a DCC will be enrolled in the program. Awards will be for five years. The deadline for receipt of applications is July 17, 1989. Applications received after this date will not be considered. Only institutions in the United States will be eligible for participation. The RMUs will recruit, evaluate and treat the patients in the clinical studies. The DCC will have primary responsibilty for data collection and management. Planning and implementation of the studies will be supervised by a Steering Committee consisting of principal investigators (PIs) from each of the RMUs, the PI of the DCC, and the NICHD Program Officer for Reproductive Medicine, who will act as Research Coordinator. Each PI will serve as chairperson on a rotating basis. MECHANISM OF SUPPORT The funding mechanism to be used to assist the scientific community in undertaking this system of clinical investigation will be a Cooperative Agreement between the participating units and NICHD. The major difference between a Cooperative Agreement and a research grant is that there will be substantial programmatic involvement of NICHD staff above and beyond the levels required for traditional program management of grants. 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 other HHS, PHS, and NIH grant administration policies. APPLICATION AND REVIEW PROCEDURES Any application which does not meet the minimum requirements (see Additional Information, below) of this RFA will be returned to the applicant without technical review. Applications meeting the minimum requirements will be reviewed as a group on a competitive basis with each other and in accordance with the usual NIH peer review procedures for research grants. Responsive applications may be subjected to a triage by a peer-review group to determine their scientific merit relative to the other applications received in response to this RFA. NIH will withdraw from competition those applications judged to be noncompetitive, and notify the applicant and institutional business official. The review will be conducted first for scientific and technical merit by a special review committee convened specifically for this purpose by the Scientific Review Program, NICHD. This will be followed by a second-level review by the National Advisory Child Health and Human Development Council. Applications must be submitted on form PHS 398 (revised 9/86), which is available in most institutional business offices or from the Division of Research Grants, NIH. Applications should be identified by checking the "yes" box in Item Number 2 on the face page of the application, and typing in the words, "In Response to RFA-HD-89-04." In addition, the RFA label available in the 9/86 revision of Application Form 398 must be affixed to the bottom of the face page and placed on top of your entire package. Failure to use this label could result in delayed processing of your application, such that it may not Vol. 18, No. 4, February 10, 1989 - Page 6 reach the review committee in time for review. The original and four (4) copies should be received by the Division of Research Grants no later than July 17, 1989. Applications should be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892** In addition to those applications mailed to the Division of Research Grants, two (2) copies of the application should be sent to: Laurance Johnston, Ph. D. Scientific Review Program National Institute of Child Health and Human Development National Institutes of Health Executive Plaza North, Room 520 Rockville, Maryland, 20892 (Courier Zip Code 20852) ADDITIONAL INFORMATION Potential applicants should obtain a detailed Request for Applications from: Donna L. Vogel, M.D., Ph.D. Reproductive Sciences Branch Center for Population Research National Institute of Child Health and Human Development Executive Plaza North, Room 603 Rockville, Maryland 20892 Telephone: (301) 496-6515 This Program is described in the Catalog of Federal Domestic Assistance number 13.864, Population Research. Awards will be made under the authority of the Public Health Service Act, Title X, Section 1004 (Public Law 92-572, as amended; 42 USC 241) and Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241). This program is not subject to Executive Order 12372 or Health Systems Agency review. PUBLIC-ACADEMIC FELLOWSHIP PROGRAM IN MENTAL HEALTH SERVICES RESEARCH RFA AVAILABLE: MH-89-14 P.T. 22; K.W. 0715129, 0730050 National Institute of Mental Health Application Receipt Date: May 4, 1989 The National Institute of Mental Health (NIMH) requests applications for a fellowship training program designed to support training of developing investigators in the skills required for effective research concerning mental health service delivery in the public sector. Consideration will also be given to training in clinical research on the severely mentally ill. The program is also intended to enhance the ability of States and other public sector organizations to conduct research on the treatment and delivery of services, especially to severely mentally ill adults and children. These fellowships will support full-time research training for medical students or psychiatric trainees who intend to pursue a research career. Domestic public or private nonprofit institutions and professional and scientific organizations and associations may apply. It is anticipated that in fiscal year 1989, up to $175,000 will be for the support of one postdoctoral program. NIMH will accept applications under the single receipt date of May 4, 1989. Potential applicants wishing further information should contact: Vol. 18, No. 4, February 10, 1989 - Page 7 Dr. Kenneth G. Lutterman Associate Director for Research Training and Resource Development Division of Biometry and Applied Sciences, NIMH 5600 Fishers Lane, Room 18C-26 Rockville, Maryland 20857 Telephone: (301) 443-3685 RESEARCH ON SERVICES FOR PERSONS WITH MENTAL DISORDERS THAT CO-OCCUR WITH ALCOHOL AND/OR DRUG ABUSE RFA AVAILABLE: MH-89-13 P.T. 22; K.W. 0715129, 0404003, 0404009 National Institute of Mental Health National Institute on Alcohol Abuse and Alcoholism National Institute on Drug Abuse Application Receipt Date: May 4, 1989 The National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Institute on Drug Abuse (NIDA) seek applications for studies of alcohol, drug, and mental health services for individuals whose multiple diagnoses include mental disorder(s) as well as alcohol and/or drug abuse disorders. Support may be requested through applications for a regular research grant, Small Grant, First Independent Research Support and Transition (FIRST) Award, ADAMHA Scientist Development Award, and ADAMHA Scientist Development Award for Clinicians. Applicants may request support for up to 5 years (with the exception of small grant applications, which are limited to 2 years). It is anticipated that up to $2.5 million will be available to support new grant awards under this RFA during fiscal year 1989, subject to the availability of funds. Funding in future years will depend on annual appropriations. NIMH will accept applications under the single receipt date of May 4, 1989. Potential applicants are encouraged to discuss their planned research with NIMH staff listed below before submitting a formal grant application: Dave Larson, M.D., M.S.P.H., or Charles Windle, Ph.D. Biometric and Clinical Applications Branch Division of Biometry and Applied Sciences, NIMH Parklawn Building, Room 18C-24 5600 Fishers Lane Rockville, Maryland 20857 Telephone: Dr. Larson (301) 443-1330 Telephone: Dr. Windle (301) 443-4233 CANCER PREVENTION AND CONTROL RESEARCH SMALL GRANTS PROGRAM RFA AVAILABLE: 89-CA-09 P.T. 34; K.W. 0715035, 0745027, 0795003, 0745035, 0404000, 0710030 National Cancer Institute Application Receipt Date: May 5, 1989 I. INTRODUCTION The Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI) invites Small Grants research applications (R03) in areas relevant to the cancer prevention and control program as noted below. New as well as experienced investigators in relevant fields and disciplines (e.g., disease prevention and control, medi-cine, public health, health promotion, epidemiology, social work, nursing research, nutrition, health policy, health services research, and behavioral sciences, such as social psychology, health education, sociology, and community organization) may apply for small grants to test ideas or do pilot studies. Up to 30 awards will be made under this RFA if meritorious applications and funds are available. Under previous RFAs, 79 awards have been made. Vol. 18, No. 4, February 10, 1989 - Page 8 II. BACKGROUND INFORMATION Cancer control is defined as the reduction of cancer incidence, morbidity, and mortality through an orderly sequence from research on interventions and their impact in defined populations to the broad, systematic application of the research results. Cancer control research studies are classified into one of five phases which represent the orderly progression noted in the above definition: (I) hypothesis development; (II) methods development and testing; (III) controlled intervention trials to establish cause-and-effect relationships; (IV) research in defined human populations; and (V) demonstration and implementation studies. The Division is interested primarily in research on cancer control intervention in Phases II through V. III. RESEARCH GOALS AND SCOPE A Cancer Prevention and Control Research Small Grants Award is designed to encourage investigators from a variety of academic, scientific, and public health disciplines to apply their skills to scientific investigations in the field of human cancer control intervention research. Within this small grant program, investigators may chose any of the full range of scientific approaches in their work. Many studies and research designs may contribute to the design, implementation or evaluation of future phase III-V studies, e.g., descriptive baseline surveys, testing, modification and validation of surveys or program materials for use in the proposed population groups, testing of recruitment or compliance procedures for participants, etc. The research may occur in a variety of settings, such as communities, schools, health departments, worksites, etc. These investigators will become part of the new nationwide group of scientists pursuing cancer control research goals. PROGRAM AREAS OF INTEREST The NCI has announced a goal and objectives for achieving a 50 percent reduction in the cancer mortality rate by the Year 2000 (Greenwald, P., Sondik, E.J. Cancer Control Objectives For the Nation: 1985-2000, NCI Monograph No. 2, 1986). Cancer Control Program areas appropriate for research grants include HUMAN INTERVENTION research in the following areas: o Prevention (chemoprevention, diet and nutrition intervention studies). o Screening and early detection, e.g., pilot studies of new methods; application of the "NCI guidelines for early detection". In the area of breast screening and detection, studies of breast self-examination as a single modality will not be accepted. o Cancer control sciences (studies to change current behaviors and/or institute new behaviors or health promotion interventions effective in reducing incidence, morbidity or mortality from cancer). o Smoking prevention and cessation pilot studies targeted at improving UTILIZATION of current technologies in target populations or organizations are encouraged. Minor enhancements of existing technology are NOT encouraged. o Applications research in modifying, feasibility testing, and adopting proven, state-of-the-art intervention programs and strategies from other research projects (e.g., screening, smoking prevention, etc.) for use in special populations, state and local health agencies, or other organizational and community settings. In addition, planning, epidemiologic, and survey studies aimed at developing cancer control interventions, or cancer control operations research and evaluation studies. o Community oncology (improving the application of patient management and continuing care research advances into community settings). o Applied epidemiology (using epidemiologic methods to determine the association between exposure to an INTERVENTION and its impact on disease). EXCLUSIONS Studies to determine the efficacy of chemotherapy, surgery, radiotherapy, and other primary treatment interventions are not considered cancer control research under this RFA. Other animal studies are not allowed. Vol. 18, No. 4, February 10, 1989 - Page 9 IV. MECHANISMS OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) grant-in-aid. Total costs (direct plus indirect) must not exceed $35,000. The duration of support is one year but may be longer (up to two years) if the $35,000 funding limit is not exceeded for the entire project. V. ELIGIBILITY Applicants may be established researchers, new investigators, qualified staff of public health departments and collaborating agencies, and predoctoral investigators. DISSERTATION research proposals are allowed. The only INELIGIBLE applicants are: (1) those individuals who are or have previously been Principal Investigator on an NCI funded CANCER CONTROL grant or contract for more than TWO years; (2) previous recipients (principal investigators) of a DCPC small grant; (3) foreign institutions. VI. INQUIRIES Written or telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged and should be directed to the program director below. The program director welcomes the opportunity to clarify any issues or questions from potential applicants. Carlos E. Caban, Ph.D. Program Director for Cancer Control Research Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 218 Bethesda, Maryland 20892 Telephone: (301) 496-8577 ONGOING PROGRAM ANNOUNCEMENTS RESEARCH ON CHILDREN OF ALCOHOLICS P.T. 34, AA; K.W. 0404003, 1002019, 0760003 National Institute on Alcohol Abuse and Alcoholism PURPOSE This announcement seeks epidemiological research on children of alcoholics as well as well-controlled research that provides a foundation for the development of effective preventive and early intervention programs to alleviate the potential adverse effects of parental alcoholism and related genetic and environmental factors on this population. RESEARCH OBJECTIVES The National Institute on Alcohol Abuse and Alcoholism (NIAAA) encourages a variety of studies aimed at furthering our understanding of the genetic traits, environmental factors, and individual strengths and vulnerabilities of children of alcoholics. NIAAA is particularly interested in research that includes large, nonclinical populations of children of alcoholics, research on biological markers for alcoholism, research on genetic, environmental, or individual factors that may "buffer" children of alcoholics from the adverse effects of parental alcoholism, and research that compares children of actively drinking alcoholics to children of abstinent alcoholics or to children of parents with other chronic problems such as depression or renal disease. MECHANISM OF SUPPORT Applications received in response to this announcement will compete with others submitted to NIAAA for funding. Support may be requested for a period of up to 5 years (renewable for subsequent periods). Grant funds may be used for expenses clearly related and necessary to carry out research projects, including both direct costs which can be specifically identified with the project and allowable indirect costs of the institution. Funds may not be used to establish, add a component to, or operate a treatment, rehabilitation, or prevention service program. Vol. 18, No. 4, February 10, 1989 - Page 10 ELIGIBILITY Applications may be made by public or private nonprofit or for-profit organizations such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal Government. APPLICATION PROCEDURES All applications in response to this announcement must be submitted on Application form 398 Rev. 9/86. Insert on line 2 of the application face page the title "Research on Children of Alcoholics". INQUIRIES All inquiries and requests for the full text of this announcement should be directed to: Jacqueline Wallen, Ph.D. Project Officer, Treatment Research Branch Division of Clinical and Prevention Research, NIAAA Parklawn Bldg., Room 16C03 5600 Fishers Lane Rockville, Maryland 20857 Telephone: (301) 443-0796 ERRATA ADAMHA SCIENTIST DEVELOPMENT AWARD AND ADAMHA SCIENTIST DEVELOPMENT AWARD FOR CLINICIANS P.T. 34; K.W. 0710030, 0404003, 0404009, 0715095 National Institute of Mental Health National Institute on Alcohol Abuse and Alcoholism National Institute on Drug Abuse In the NIH Guide for Grants and Contracts, Vol. 7, No. 44, December 30, 1988, information was missing from the first paragraph. The first paragraph is repeated below in its entirety. The Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA), which includes the National Institute of Mental Health (NIMH), the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and the National Institute on Drug Abuse (NIDA), announces the ADAMHA Scientist Development Award (SDA) and the ADAMHA Scientist Development Award for Clinicians (SDAC). The SDA and SDAC are awards to foster the development of outstanding scientists and enable them to expand their potential for making important contributions to the fields of alcoholism, drug abuse, or mental health (ADM) research. The SDA is for highly promising developing scientists who need further supervised research experience in order to undertake independent research. The SDA provides 5 years of support; in exceptional circumstances, an established investigator who needs supervised research experience to enable him or her to switch fields may apply for up to 2 years of support. The SDAC is intended to meet the need for supervised experience for individuals trained primarily as clinicians, especially physicians, who show special promise for a research career. The SDAC provides 5 years of support, with eligibility taking into account that the candidate has been trained primarily as a clinician and thus may possess only minimal research skills. Such an individual must show genuine commitment to a research career to justify the need for a 5-year development award. In addition, the spelling of the name of the Chief, Epidemiology Branch, Division of Biometry and Epidemiology, NIAAA, is Mary Dufour. The room number for Edgar Adams, Sc.D., Director of Epidemiology and Statistical Analysis, NIDA, is 11A-55, and his telephone number is 301-443-6504. NIMH should be inserted before the names of Drs. Lutterman, Schneider, and Lash. Vol. 18, No. 4, February 10, 1989 - Page 11 DEVELOPMENT OF SMALL ANIMALS EXPRESSING HUMAN IMMUNODEFICIENCY VIRUS GENES AS MODELS FOR THERAPY RFA: 89-AI-05 P.T. 34; K.W. 0715008, 1002002, 0765033, 0740023, 0760015 National Institute of Allergy and Infectious Diseases This announcement was published in the NIH Guide for Grants and Contracts on December 23, 1988, Vol. 17, No. 43. The following sentence was omitted from that announcement: "Only R01 applications will be considered in response to this RFA." Vol. 18, No. 4, February 10, 1989 - Page 12 FULL TEXT OF RFAs FOR ONLINE ACCESS AVAILABILITY OF REQUEST FOR COOPERATIVE AGREEMENT APPLICATIONS: RFA 89-HD-04 COOPERATIVE MULTICENTER REPRODUCTIVE MEDICINE NETWORK NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT P.T. 34; K.W. 0715167, 0785135, 0413002, 0785035 Application Receipt Date: July 17, 1989 OVERVIEW The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the assistance of NICHD under Cooperative Agreements in a multicenter cooperative clinical study designed to investigate problems in adult reproductive medicine, including reproductive endocrinology, obstetrics and gynecology, and andrology. The objective of this study is to facilitate resolution of these problems by establishing a network of centers that, by vigorous patient evaluation using common protocols, can study large numbers of patients and can provide answers more rapidly than individual centers acting alone. The benefit of this activity will be to the public: the infertile couples, the individuals with reproductive diseases and disorders, and their health-care providers. The Institute program staff will cooperate with the principal investigators of the selected reproductive medicine units (RMUs) in identifying research topics of high priority, and in designing protocols appropriate to the evaluation of optimum management in these areas. Awards will be for five years. It is anticipated that the program will consist of four phases, defined as follows (duration of phases is estimated only): Phase 1 (Six months) Review and identification of issues of importance in reproductive medicine, and ranking of those issues according to patient need. Phase 2 (Six months) Design of diagnostic and treatment protocols and data sets to be accepted in common by participating organizations. Phase 3 (48 months) Institution of clinical trial protocols, data collection, and data transfer. Phase 4 (40 months) Initiation of planning pertaining to termination of studies, addition of new protocols, and delineation of future research needs. This phase will begin six months after Phase 3 has started. It is anticipated that approximately six clinical centers will be enrolled in the program. The deadline for receipt of applications is July 17, 1989. Applications received after this date will not be considered. The need for continuous and active communication among centers mandates that only institutions in the United States will be eligible for participation. BACKGROUND Within the mission of the National Institute of Child Health and Human Development, a preeminent goal is assuring the birth of wanted babies through studies on human fertility and infertility. To this end, the Reproductive Sciences Branch supports research on human fertility and infertility, and diseases and disorders of the human reproductive system. The area of reproductive health care has, in some instances, put into use diagnostic and therapeutic practices without sufficiently rigorous controlled evaluation of their effectiveness. An easily appreciated example is the diagnosis and treatment of infertility. Fervent desire to have a child, combined with the perception of a defect in such central attributes as their sexuality and fecundity, makes these couples vulnerable and highly suggestible. In the absence of reliable knowledge about the natural history of unprotected intercourse, many couples have been erroneously labeled as infertile, subjected to testing and useless treatments, then gone on to conceive on their own. This baseline of conceptions occurring after a long interval severely compromised the ability to interpret reproductive success following a variety of dietary, vitamin, hormonal, and other therapies. Uncontrolled, trial-and- error methods led to undeserved claims of effectiveness, and resulted in significant costs, both human and financial. Historically, useless and even harmful tests and treatments for "female troubles," impotence, and other reproductive disorders formed a significant component of the annals of quackery. Despite subsequent years of careful, modern research, there is damage yet to be undone. The present demographic trend to delayed childbearing makes the problem especially timely. Older couples with apparent infertility have little time to waste. There is a greater need than ever to be able to identify reproductive disorders quickly and accurately, to describe subpopulations of infertility and subfertility, and to be able to provide the most appropriate therapies with the least possible delay. There are a number of controversies in Reproductive Medicine which would lend themselves to cooperative study. The following should by no means be viewed as exclusive, and are intended only as examples: o Endometriosis: Controlled trials of treatments, examining post- treatment fertility and/or symptom reduction. o Polycystic ovarian syndrome: Definition, subgroups, response to therapies. o Leiomyomata: Epidemiology, natural history, effects on fertility, alternate therapeutic strategies. o Pelvic inflammatory disease: Diagnosis, relationship to infertility and ectopic pregnancy, prognosis after various therapies. o Varicocele: Effect on fertility, benefits of surgery. o Impotence: Diagnosis, definition of subpopulations, controlled trials of therapies. o The effects of systemic diseases and/or their treatments upon sexual health and fertility. On September 9, 1988, the Director of the Center for Population Research met with a diverse group of experts in academic reproductive medicine, including one member of the National Advisory Child Health and Human Development Council. These consultants reviewed a concept clearance for the Network here proposed, and encouraged the NICHD to go forward with its plans to develop the program. Use of this cooperative mechanism would have many advantages: It could identify issues with a high degree of objectivity, develop well-designed protocols, provide to participants expert statistical consultation in experimental design and analysis, and provide a large patient base, so that tests and treatments could be evaluated more rapidly and with greater statistical validity than otherwise. The anticipated efficiency of communication among investigators, and dissemination of information to practitioners and the public, would lead to more effective patient care and more economical use of resources. STUDY ORGANIZATION AND SCOPE The Network will include approximately six Clinical RMUs and a Data Coordinating Center. The RMUs will recruit, evaluate and treat the participants in the clinical studies. The Data Coordinating Center will have primary responsibility for data collection and management. NICHD invites applications from groups of competent, experienced investigators who can meet the following minimum requirements: o Requirements for Clinical RMU Applicants 1 Participants must be based in departments providing both inpatient and outpatient reproductive health care (see [4], below). 2 The unit must have a history of previous successful clinical research, and expertise in research design, biostatistics, and the use of clinical protocols. 3 The unit must be able to demonstrate past and existing excellence in collecting and maintaining clinical data on its patients. Applications should state the numbers of patients seen annually with the diagnoses listed as examples in II, above, and how many of those patients have participated in previous clinical trials. 4 The center should have physician staff representing multiple disciplines, either based in the participating department or available as collaborators. At a minimum, these would include Obstetrics and Gynecology, Reproductive Endocrinology (either in OB-Gyn or Internal Medicine), and Andrology (either in Internal Medicine or Urology). If the specialty of the principal investigator is in disorders of one sex, a co-principal investigator may be designated from the specialty dealing with the opposite sex. 5 An experienced research nurse must be among the key personnel, and additional research nursing staff should be available. 6 Laboratory facilities must be available for appropriate testing of patients and subjects, covering hematology, blood chemistry, endocrinology, microbiology, radioimmunoassay, and clinical genetics. 7 Appropriate imaging services must be available, including ultrasound, contrast studies, and other radiological techniques as may be required to diagnose and follow the conditions under study. 8 The unit must be prepared to participate in a cooperative manner with other clinical centers and the Data Coordinating Center in the delineation of research protocols, statistical methods, uniform data formats, and data transfer. 9 There must be firm institutional and departmental commitments to support this cooperative study, and a strong staff dedication to adhere to programs jointly defined and to generate data of high fidelity to ensure success. The following are desirable requirements. If satisfied, they will be considered strengths of the application: 1 In order to speed communication and data transmission, the cooperating institution should have a computer facility which is a BITNET node, and the unit should include an authorized user knowledgeable in computer data storage and retrieval. (Awards will not include funds to establish such facilities.) 2 The unit should have previous experience in multicenter clinical trials. 3 The professional staff should have as a goal increased communication and cooperation among their various disciplines. o Requirements for Data Coordinating Center Applicants 1 The applicant must have demonstrated prior experience as a Coordinating Center in multi-center studies. 2 The Principal Investigator, with other staff, must have appropriate biostatistical, data management, and coordination expertise. 3 The applicant must have ability to assist in designing protocols and the data collection system. 4 Experience in developing and monitoring quality control shall be demonstrated. 5 The Data Coordinating Center will report to the Steering Committee every six months regarding accumulating data and the RMUs' performance. The application should document ability to meet such reporting deadlines as well as the overall timetable. 6 The applicant must be prepared to cooperate with the RMUs and NICHD staff in all design, collection, and analysis functions. In the interest of efficiency, Data Coordinating Center access to and knowledge of BITNET is desirable, and will be regarded as a strength. o Guidance and Management: The Steering Committee Planning and implementation of studies will be supervised by a Steering Committee consisting of principal investigators from each of the participating RMUs; the principal investigator of the Data Coordinating Center; and the NICHD Program Officer for Reproductive Medicine, who will act as Research Coordinator. The chairperson will be selected on a rotating basis from among the principal investigators. The Director of the Center for Population Research, NICHD, may be invited to attend the meetings of the Steering Committee, strictly in an advisory capacity. o General Scope of the Study Protocols for the studies to be carried out under this Cooperative Agreement will be developed by consensus among the principal investigators and NICHD staff, i.e. the Steering Committee. The protocols to be developed will: 1 Study patients followed in the unit who are eligible for specific protocols. More than one protocol may be active at any given time. 2 Indicate sample size and need for control patients, including criteria for their selection. 3 Identify specific requirements and appropriate end- points needed for the particular clinical question under study. 4 Determine the type and time of follow-up indicated. The conduct of the Cooperative Agreement is expected to follow this general outline (duration of phases are estimates only): Phase 1: (Six months) The Steering Committee will review and identify issues of appropriate clinical management in reproductive medicine. It will consider items proposed for study by the Network from those listed in II (BACKGROUND) and others suggested by participating units. It will modify and rank by priority a series of issues which are substantive, lie within the scope of existing technical appraisal, lend themselves to multicenter evaluation, involve sufficient numbers of patients to be of consequence in terms of morbidity, and comprise significant concerns in reproductive health care. Support during this period will be mainly for each principal investigator for travel to Bethesda, Maryland, approximately four times, or as needed. In this and subsequent phases, the Steering Committee will attempt to use electronic and facsimile communication whenever possible. Phase 2: (Six months) From the list of important issues determined in phase 1, the Steering Committee will generate diagnostic or treatment protocols and recommendations for data format. These protocols are to be accepted by all the participants, adequate for appraisal of the research issues defined, and amenable to data collection in a single format acceptable to all units. Satisfactory controls will be incorporated, and attention will be given to maximize the number of studies possible with minimum data collection. Protocol subcommittees may be constituted to develop protocols more efficiently. Support for this phase will be for travel to Bethesda for each principal investigator. Phase 3: (48 months) Participating reproductive medicine units will incorporate the protocols into the clinical management of patients selected for study. Phases 3 and 4 will run concurrently. Under Phase 3, the units will collect the data with adequate attention to the fidelity of records and transcription and provide information in uniform data format for analysis. The mode of data transmission and analysis will be determined by the Steering Committee in conjunction with the recommendations of the Data Coordinating Center. Data summaries will be provided to the Steering Committee on a semi-annual basis, or as indicated by study development. Format and content of final reports and the dissemination of information to the scientific community will be determined by the Steering Committee. Phase 4: (40 months) Based on reports of the aggregated data, the Steering Committee will decide on the need to terminate studies, either because the data suffice to answer the problems posed, data collection provides support for an alternative study initiative, or because experience has proven the research not to be feasible. As studies are terminated, the Steering Committee will re-initiate Phase 1 and devote itself to the identification of new issues and the institution of new protocols, as described above. In circumstances in which observations lend support to the need of special research studies or long-term follow-up of patients, the Steering Committee will make recommendations to the appropriate program within NICHD for the development of program announcements or requests for applications. This phase will begin six months after Phase 3 has started. o Content of Applications To respond to this Request for Applications, proposals from applicants should include: 1 A description of the capabilities of the unit to meet or exceed the minimum requirements (RMU or Data Coordinating Center). 2 A description of the applicant's perception of the study and of their cooperative role in participating. 3 For RMUs only, a proposed protocol for a new study to be conducted by the Network on a topic of the applicant's choice, to serve as an indicator of the applicant's ability to participate in the design of protocols for such cooperative clinical investigations. The protocol should be written specifically for this Network, and will be a key factor in evaluation of the application. 4 For Data Coordinating Center applicants only, a plan detailing methods of data receipt, analysis, and reporting, including communication with clinical and administrative personnel. MECHANISM OF SUPPORT The funding mechanism to be used to assist the scientific community in undertaking this system of clinical investigation will be a Cooperative Agreement between each participating unit and NICHD. The major difference between a Cooperative Agreement and a research grant is that there will be substantial programmatic involvement of NICHD staff above and beyond the levels required for traditional program management of grants. Specifically, the awardees will develop the protocols with assistance from NICHD staff. All parties will agree to accept the coordinating role of the group and the participatory and cooperative nature of the group process. The primary authorities and responsibilities of the awardees are: o Define objectives and approaches; o Plan the design and implementation of the protocols; o Conduct the studies; o Collect and analyze the data; o Publish the results, conclusions and interpretations of the studies. o Modify, delete or add protocols. The following lists the degree of involvement by NICHD staff: o Assist in and facilitate the development of study protocols; o In conjunction with the Steering Committee, review and comment on each stage of the program before subsequent stages are started, including options of modification or termination by mutual consent; o Retain the option to withhold support of a participating unit, if technical performance requirements such as compliance with the protocol, meeting patient enrollment targets, and adherence to uniform data format are not met. Support will be contingent upon meeting these requirements. Alternatively, determine jointly with the awardees, the need to add units. o Assist, through review, comment, analysis and co- authorship, in reporting results to the community of investigators and health care recipients. Those specific terms and conditions of the award, and details of arbitration procedures pertaining to the scope and nature of the interaction between NICHD and the participating RMUs and Data Coordinating Center, will be incorporated into the Notice of Grant Award. These procedures will be in addition to the customary programmatic and financial negotiations which occur in the administration of grants. The arbitration procedures will be invoked only when agreement cannot be reached on issues that may arise after the award between the awardee and NICHD staff. In that event, an arbitration panel will be formed consisting of one person selected by the principal investigators, one person selected by NICHD staff, and a third person selected by these two members. The decision of the arbitration panel will be binding. The above 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 other HHS, PHS, and NIH grant administration policies. Cooperative Agreements are subject to the administrative requirements outlined in OMB circulars A-102 and A-110; and all pertinent HHS, PHS, and NIH grant regulations, policies and procedures, with particular emphasis on HHS regulations at 42 CFR Part 52 and 45 CFR Part 74, are applicable. The NIH Information for Management and Planning Analysis and Coordination (IMPAC) system and indirect cost award procedures will apply to Cooperative Agreement awards in the same manner as for grants. The special arbitration procedures described above in no way affect the right of a recipient of a cooperative agreement assistance grant to appeal an adverse determination in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16 and 75. Business management aspects of these awards will be administered by the NICHD Grants Management Office in accordance with HHS, PHS, and NIH grant administration requirements. REVIEW CRITERIA AND PROCEDURES o Review Procedure Any application which does not meet the minimum requirements (see ORGANIZATION AND SCOPE, above) of this RFA will be returned to the applicant without technical review. Applications meeting the minimum requirements will be reviewed as a group on a competitive basis with each other and in accordance with the usual NIH peer review procedures for research grants. Responsive applications may be subjected to a triage by a peer-review group to determine their scientific merit relative to the other applications received in response to this RFA. NIH will remove from competition those applications judged to be noncompetitive for award, and notify the applicant and institutional business official. The review will be conducted first for scientific and technical merit by a special review committee convened specifically for this purpose by the Scientific Review Program, NICHD. This will be followed by a second-level review by the National Advisory Child Health and Human Development Council. o Criteria for Review for Clinical RMUs Applications meeting the minimum requirements, unless withdrawn by triage review, will be evaluated on technical merit according to the criteria listed below. 1 Qualifications, Experience, and Commitment of Key Personnel Scientific, clinical, and administrative abilities of the principal investigator and other team members; knowledge and experience in areas relevant to the conduct of potential studies pertaining to the clinical and laboratory evaluation of patients with reproductive disorders; commitment of staff time for the satisfactory conduct of the study; experience and qualifications of team members who would be responsible for internal coordination of activities in data management. 2 Protocols and Procedures Willingness to work and cooperate with other RMUs and the NICHD in the manner summarized in this RFA; quality of the proposed sample protocol designed to be undertaken by the Network including ethical and human subjects matters. 3 Facilities and Management Adequacy of administrative, clinical, and data organizational management facilities as described in the minimum requirements; institutional assurance to provide support to the study in such areas as fiscal administration, personnel management, space allocation, procurement, planning and budgeting. o Criteria for Review for the Data Coordinating Center Applications meeting the minimum requirements will be evaluated on technical merit according to the criteria listed below. 1 Qualifications, Experience, and Commitment of Key Personnel Scientific and administrative abilities of the principal investigator and other team members; experience of the principal investigator and other key personnel in statistical, data management, quality control, study coordination, and administrative aspects of multicenter clinical studies; commitment of staff time for satisfactory conduct of the study; understanding of the scientific objectives and design of the program, as evidenced by discussion of design (Phase 1), recruitment and implementation issues (Phase 2). 2 Protocols and Procedures Proposed data collection and monitoring system; discussion of ability to meet proposed timetable; willingness to work cooperatively with the RMUs and the NICHD, in the manner summarized in this RFA. 3 Facilities and Management Satisfactory facilities and supporting environment, including space and equipment for the work proposed (any new equipment requested under this award must be adequately justified); evidence of institutional support for participation in a long-term collaborative program. METHOD OF APPLYING 1 Application Procedure Applications must be submitted on form PHS 398 (revised 9/86), which is available in most institutional business offices or from the Division of Research Grants, NIH. Applications should be identified by checking the "yes" box in Item Number 2 on the face page of the application, and typing in the words, "In Response to RFA-HD-89-04." In addition, the RFA label available in the 9/86 revision of Application Form 398 must be affixed to the bottom of the face page and placed on top of your entire package. Failure to use this label could result in delayed processing of your application, such that it may not reach the review committee in time for review. The original and four (4) copies should be received by the Division of Research Grants no later than July 17, 1989. If a clinical RMU applicant elects to submit an application for the Data Coordinating Center, this must be done under a separate application, appropriately labeled, and with a separate budget. Applications should be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892 In addition to those applications mailed to the Division of Research Grants, two (2) copies of the application should be sent to: Laurance Johnston, Ph. D. Scientific Review Program National Institute of Child Health and Human Development National Institutes of Health Executive Plaza North, Room 520 Rockville, Maryland, 20892 (Courier Zip Code 20852) 2 Budget The instructions for budget estimates provided with the Research Grant Application Form (PHS 398) should be followed. Indirect costs will be awarded in the same manner as for research project grants (R01). Budgets will be reviewed on the basis of appropriateness for the work proposed. Allowable costs and policies governing the research grants programs of the NIH will prevail. In planning the budget section of the proposal, each applicant should submit detailed budget estimates for all phases including estimates of staffing needs. It is envisioned that Phase 1 will be concerned primarily with support of the principal investigators for travel and participation in the meetings required for joint identification of topics, the development of protocols, and the design of data gathering instruments. Four meetings in Bethesda, Maryland are anticipated as necessary to accomplish this work and to complete a manual of operations. The protocols for the studies will not be known at the time of submission of the application; therefore, Phase 1 budgets are to cover travel only. The Phase 2 budget should include estimates of travel expenses for two meetings of the Steering Committee and two meetings for other study personnel using Bethesda, Maryland as the basis for calculations. It is anticipated that late in Phase 2, each center will require a fractional-time senior investigator, a fractional-time research nurse, and a part-time clerk. The budget proposal for Phase 3 should, at this time, present estimated costs of participating in a study such as the proposed sample protocol, including support for a full-time research nurse/study coordinator, fractional-time senior investigator, fractional-time data clerk, and travel for the principal investigator to two Steering Committee meetings per year in Bethesda. Because of the need to retain flexibility in the conduct of the operation of the Network, it will be necessary to adjust budgets prior to the initiation of Phases 3 and 4. Therefore, funding levels for Phases 3 and 4 will be subject to negotiation between the grantee institutions and the NICHD prior to awarding funds. Phase 4 is likely to consist of 2-3 meetings of the Steering Committee. A summary of sources of actual and pending support for each investigator participating in the study, with grant or other award number identification and percent effort, should be included in the application. 3 Deadline for Submission The deadline for receipt of applications by the NIH Division of Research Grants is July 17, 1989. Applications received after this date will be returned to the applicant. TIMETABLE: Receipt Date: July 17, 1989 Review by Initial Review Group: October/November, 1989 Review by NACHHD Council January 29, 1990 Earliest Award Date: April 1, 1990 4 Additional Information For further information, investigators are encouraged to contact the NICHD staff members listed below: Regarding Scientific Content Donna L. Vogel, M.D., Ph.D. Reproductive Sciences Branch National Institute of Child Health and Human Development Executive Plaza North, Room 603 Rockville, Maryland 20892 (301) 496-6515 Regarding Administrative Policy Alice Thomas Office of Grants and Contracts National Institute of Child Health and Human Development Executive Plaza North, Room 505 Rockville, Maryland, 20892 (301) 496-5481 _________________________________________________________________ This Program is described in the Catalog of Federal Domestic Assistance number 13.864, Population Research. Awards will be made under the authority of the Public Health Service Act, Title X, Section 1004 (Public Law 92-572, as amended; 42 USC 241) and Title III, Section 301 (Public Law 78-410, as amended; 42 USC 241). This program is not subject to Executive Order 12372 or Health Systems Agency review. REQUEST FOR APPLICATIONS FOR RESEARCH SMALL (R03) GRANTS RFA NUMBER: RFA 89-CA-09 RFA TITLE: CANCER PREVENTION AND CONTROL RESEARCH SMALL GRANTS PROGRAM P.T. 34; K.W. 0715035, 0745027, 0795003, 0745035, 0404000, 0710030 NATIONAL CANCER INSTITUTE APPLICATION RECEIPT DATE: MAY 5, 1989 I. INTRODUCTION The Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI) invites Small Grants research applications from interested investigators. This program is designed to aid and facilitate the growth of a nationwide cohort of scientists with a high level of research expertise in the field of human cancer control intervention research. New as well as experienced investigators in relevant fields and disciplines (e.g., disease prevention and control, medicine, public health, health promotion, epidemiology, social work, nursing research, nutrition, health policy, health services research, and behavioral sciences, such as social psychology, health education, sociology, and community organization) may apply for small grants to test ideas or do pilot studies. This RFA is a modified reissuance of RFA 87-CA-37. The five prior Small Grant RFAs have resulted in 79 awards. The plans are to issue this RFA at least annually for three more years with up to 30 awards per year if meritorious applications and funds are available. ________________________ This program is described in the Catalog of Federal Domestic Assistance, No. 13.399, (Cancer Control). Awards are under the 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 284) and administered under PHS grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the inter- governmental review requirements of Executive Order 12372 for Health Systems Agency review. II. BACKGROUND INFORMATION DEFINITION OF CANCER CONTROL Cancer control is defined as the reduction of cancer incidence, morbidity, and mortality through an orderly sequence from research on interventions and their impact in defined populations to the broad, systematic application of the research results. PHASES OF CANCER CONTROL Cancer control research studies are classified into one of five phases which represent the orderly progression noted in the above definition: (I) hypothesis development; (II) methods development and testing; (III) controlled interven- tion trials to establish cause-and-effect relationships; (IV) research in defined, human populations; and (V) demon- stration and implementation studies. The Division is interested primarily in research on cancer control inter- vention in Phases II through V. III. RESEARCH GOALS AND SCOPE A Cancer Prevention and Control Research Small Grants Award is designed to encourage investigators from a variety of academic, scientific, and public health disciplines to apply their skills to scientific investigations in the field of human cancer control intervention research. The research may occur in a variety of settings, such as communities, schools, health departments, worksites, etc. These invest- igators will become part of the new nationwide group of scientists pursuing cancer control research goals. RESEARCH APPROACHES Within this small grant program, investigators may chose any of the full range of scientific approaches in their work. Many studies and research designs may contribute to the design, implementation or evaluation of future phase III-V studies, e.g. descriptive baseline surveys, testing, modifi- cation and validation of surveys or program materials for use in the proposed population groups, testing of recruitment or compliance procedures for participants, etc. Investigators must address the specific aims and hypotheses, the background and significance of the proposed work, results of any preliminary studies, experimental design and methods including any relevant theoretical concepts which underly the research, human subjects involvement and protection, and relevant literature(see instructions in the grant application). PROGRAM AREAS OF INTEREST The National Cancer Institute has announced a goal and objectives for achieving a 50% reduction in the cancer mortality rate by the Year 2000 (Greenwald, P., Sondik, E.J. Cancer Control Objectives For the Nation: 1985-2000. NCI Monograph No. 2, 1986). Cancer Control Program areas appropriate for research grants include HUMAN INTERVENTION research in the following areas: o Prevention (chemoprevention, diet and nutrition intervention studies) o Screening and Early Detection, e.g., pilot studies of new methods; application of the "NCI guidelines for early detection". In the area of breast screening and detection, studies of breast self-examination as a single modality will not be accepted. o Cancer control sciences (studies to change current behaviors and/or institute new behaviors or health promotion interventions effective in reducing incidence, morbidity or mortality from cancer) o Smoking prevention and cessation pilot studies targeted at improving utilization of current technologies in target populations or organizations are encouraged. Minor enhancements of existing technology are not encouraged. Please contact DCPC program staff if in doubt. o Applications research in modifying, feasibility testing, and adopting proven, state-of-the-art intervention programs and strategies from other research projects (e.g., screening, smoking prevention, etc.) for use in special populations, state and local health agencies, or other organizational and community settings. In addition, planning, epidemiologic, and survey studies aimed at developing cancer control interventions, or cancer control operations research and evaluation studies. o Community oncology (improving the application of patient management and continuing care research advances into community settings). Applied epidemiology studies (using epidemiologic methods to determine the association between exposure to an INTERVENTION and its impact on disease) are acceptable within the above program areas. The titles of the 79 small grants funded under this program during 1984-1988 are provided as an appendix to this RFA. IT IS IMPORTANT THAT A LONG TERM HUMAN CANCER CONTROL HYPO- THESIS AND SUPPORTING SCIENTIFIC JUSTIFICATION MUST BE PRE- SENTED, ALTHOUGH THE SPECIFIC STUDY PROPOSED MAY ATTEMPT TO OBTAIN PRELIMINARY DATA AND/OR DO PILOT STUDIES IN SUPPORT OF A FUTURE MORE DETAILED PHASE III-V STUDY. EXCLUSIONS Studies to determine the efficacy of chemotherapy, surgery, radiotherapy, and other primary treatment interventions are not considered cancer control research under this RFA. Other animal studies are not allowed. IV. MECHANISMS OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) grant-in-aid. Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this Request for Applications (RFA), awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 82-50,000, revised January 1, 1987. This RFA is a one-time solicitation. Generally, future unsolicited competing renewal applications will compete with all investigator initiated applications and will be reviewed by Division of Research Grants (DRG). Approximately $450,000 in total costs per year for two years will be committed to specifically fund applications which are submitted in response to this RFA. It is anticipated that up to 30 awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA should not exceed two years. The earliest feasible start date for the initial awards will be August 1, 1989. Although this program is provided for in the financial plans of the National Cancer Institute (NCI), the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. Allowable direct costs include personnel, consultants, equip- ment, supplies, travel, patient care, publication and other expenses. Total costs (direct plus indirect) should not exceed $35,000. The duration of support is one year but may be longer (up to two years) if the $35,000 funding limit is not exceeded for the entire project. V. ELIGIBILITY Investigators are eligible to apply for a small grant to support research on a cancer control topic if they are inter- ested in conducting exploratory studies in cancer control research. This includes established researchers, new investigators, qualified staff of public health departments and collaborating agencies, and predoctoral investigators currently enrolled in an accredited doctoral degree program. The only INELIGIBLE applicants are (1) those individuals who are or have previously been Principal Investigator on an NCI funded CANCER CONTROL grant or contract for more than TWO years; (2) previous recipients (principal investigators) of a DCPC Small Grant; (3) foreign institutions. Non-profit organizations and institutions, governments and their agencies, and occasionally individuals are eligible to apply. For profit organizations are also eligible unless specifically excluded by legislation. Small grant research support may NOT be used to supplement research projects currently supported by Federal or non-Federal funds, or to provide interim support of projects under review by the Public Health Service. DISSERTATION RESEARCH If the research will constitute a doctoral dissertation, a written statement of approval from the applicant's disserta- tion chairperson or equivalent academic supervisor must accompany the application. If the study is selected for support under this program, a statement of approval of the full dissertation committee or equivalent is required before funding will be made. The student is usually the Principal Investigator. However, if the institutional policy does not allow this, the student's advisor may be listed as principal investigator, with appropriate clarification in the application that the project is a dissertation study. Students may wish to apply for two years of funding, not to exceed the $35,000 total costs overall. REVISED APPLICATIONS Investigators who are revising applications submitted under the previous DCPC Small Grants RFAs should follow the instructions for revised applications (Section 2, page 19, Form 398(Rev. 9/86), identifying significant changes made and responses to criticisms in the previous summary statement. VI. REVIEW PROCEDURES AND CRITERIA Upon receipt, applications will be reviewed (initially) by the Division of Research Grants (DRG) for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NCI program staff function. Applications which are judged non-responsive will be administratively inactivated, but may be submitted as investigator initiated regular research grants at the next receipt date. Questions concerning the responsiveness of the proposed research to the RFA should be directed to program staff (see Section VIII). In cases where the number of applications is large compared to the number of awards to be made, the NIH may conduct a preliminary scientific peer review to eliminate those applications which are clearly not competitive. The NIH will remove from competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Responsive applications will be reviewed for scientific and technical merit by a multidisciplinary committee convened by the NCI consisting primarily of non-Federal technical, intervention and scientific experts in relevant disciplines, such as cancer control, medicine, oncology, nursing research, public health, epidemiology, biostatistics, behavioral and social sciences (psychology, health education, sociology), community intervention, health policy, and health services research. REVIEW CRITERIA Applications will be evaluated subject to the following criteria: 1. The extent of relevance and/or contribution of the proposed research to the overall goals and objectives of the RFA and cancer control intervention research. 2. The quality of the principal investigator's education and/or scientific training, intervention experience, and potential for contribution as an investigator in the field of cancer control intervention research. 3. The scientific/technical merit of the research, including (a) originality; (b) feasibility; (c) adequacy of design; (d) plans for analyses and evaluation of data; and (e) soundness of the research plan. 4. The adequacy of resources and facilities, and the supportive nature of the research environment. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. Applicants may wish to include tables or flow charts of study designs, project timetables, expected outcome measures, sample size calculations, etc., to assist reviewers. VII. METHOD OF APPLYING The regular research grant application form PHS-398 (revised 9/86) must be used in applying for these grants. These forms are available at most institutional business offices; from the Officee of Grants Inquiries, Division of Research Grants, National Institutes of Health, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, Maryland 20892; or from the NCI Program Director named below. The RFA label available in the 9/86 revision of the Application Form 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of your applicaiton such that it may not reach the review committee in time for review. In addition, the title of the RFA "CANCER PREVENTION AND CONTROL RESEARCH SMALL GRANTS PROGRAM" and the RFA number 89-CA-09 should be typed on line 2 of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and four (4) signed, exact photocopies, in one package to the DRG at the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, Maryland 20892** At time of submission, send two (2) additional copies of the application to: REFERRAL OFFICER Division of Extramural Activities National Cancer Institute Room 848, Westwood Building 5333 Westbard Avenue Bethesda, Maryland 20892 Applications should be received by May 5, 1989. If an application is received after that date, it will be administratively withdrawn. Also, the DRG will not accept any application in response to this announcement that is the same as one currently being considered by any other NIH review group or awarding unit. NOTE: PLEASE SEND A COPY OF THE GRANT FACE PAGE AND ABSTRACT TO DR. CABAN IN ORDER TO INFORM HIM THAT THE GRANT HAS BEEN SUBMITTED. The following ADDITIONAL page limitations (typewritten, single-spaced) apply to sections l and 2 (pages 12-22) of the PHS-398 application: Section l: Biographical Sketch - do not exceed one page. Section 2: Research Plan (14 pages total; a suggested page distribution is as follows): o Specific Aims - one page. Clearly state the cancer control hypothesis and intervention to be studied. o Significance - one page. o Progress Report & Preliminary Studies-if applicable,2 pgs. o Experimental Design and Methods - ten pages. After the research plan, include the discussion of Human Subjects and the literature cited. Appendices are acceptable. These page limitations and others in the PHS-398 Application Instructions must be observed or the application will not be accepted. VIII. INQUIRIES Written or telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged and should be directed to Dr. Carlos Caban, the program director, at the address below. The program director welcomes the opportunity to clarify any issues or questions from potential applicants. Carlos E. Caban, Ph.D. Program Director for Cancer Control Research Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 218 Bethesda, Maryland 20892 Telephone: (301) 496-8577 APPENDIX: CANCER CONTROL RESEARCH SMALL GRANTS PROGRAM 1984-1988: (79 Funded Grants) Diet and Chemoprevention Studies (17): Dietary Intervention Methods and Fat Intake Reduction Validity of a Retrospective Food Frequency Questionnaire Computerized Nutrition Assessment Methane Production of Low and High Fiber Diets Biological Assessment of Dietary Fiber Intake Dietary Fat, Fecapentene Excretion and Colon Cancer Risk Plasma and Fecal Sterols: Diet, Genetics and Colon Cancer Body Composition Methodology for Breast Cancer Risk Diet Assessment Methodology for Chemoprevention Trials Ascorbic Acid as a Modulator of Selenium Bioavailability Determinants of Selecting Diets Low in Fat Life State and Women's Dietary Prevention Motives Dietary Fat and Reproductive Hormones in Women Dietary Beta-Carotene and Lung Cancer Rise in Nonsmokers Ibuprofen and Cancer: An Analysis of Human Data Vitamin D Deficiency and Prostate Carcinoma Public Beliefs about Fiber in Foods and Cancer Smoking Prevention and Cessation Studies (20): Cigarette Advertising and Cancer Control Study of Black Physicians and Smoking Intervention Strategies Identification of Biochemical Markers in Smokers' Breath Smokeless Tobacco Use Among Kentucky Youth: Feasibility Study Types and Timing of Relapse in Cigarette Smoking Cigarette Smoking Cessation and Relapse Measurement of Smoking Cessation Interventions Parametric Survival Analysis for Smoking Cessation Data Prompting Smoking Cessation in Family Practice Physician Smoking Cessation Counseling: Patient Outcomes Self-Help Smoking Cessation and Nicotine Dependence Smokeless Tobacco Use and Attitudes Among Rural Youth Smoking Cessation Program for Low-income Pregnant Women Conditioned Craving for Cigarettes and Related Phenomena Cigarette Taxation, Addiction and Smoking Control The Effects of Pharmacists' Advice on Smoking Cessation Multiple Measures of Reducing Passive Smoke Exposure Pediatrician's Role in Smoking Prevention and Cessation Smoking Relapse Prevention for Pregnant Women Analysis of Laws Restricting Smoking in Public Places Cancer Control Science Studies (18): Evaluating Effects of Health Risk Appraisal Development of Pediatric Health Risk Appraisal System Cancer Risk: Psychological Impact of Quantitative Estimates Assessment of Family History as a Cancer Screening Device Predictors of Compliance and Competence in Breast Self Exam Changing Health Behaviors for Breast Cancer Health Behavior Diary as a Method in Cancer Research Health Education for Testicular Self-Examination Increasing Participation in a Colo-rectal Screening Program Improving Cancer Detection Practices in an IPA Setting Increasing Compliance Rates for Mammography Screening Improving Screening Practices Through Patient Involvement Increasing Adherence to Screening Mammography Guidelines Controlled Trial to Improve Primary Care Cancer Screening Improving Mammography Rates in Primary Care Practice Maintenance Strategies for Breast Self Examination Practice in Black Women Breast Self Examination: Effects of Training Modality Among High Risk Women Behavior Changes Effected by Breast Self Examination Educational Programs Screening and Early Detection Studies (10): Early Identification of Those at Risk for Breast Cancer Probability of Detecting a Breast Cancer Elemental Analysis of Breast Calcifications Case-Control Studies of Breast Cancer Screening Efficacy New Test to Improve Screening for Colorectal Carcinoma Testing the Potential Use of In Vitro Tetraploidy in Colon Cancer Control Validation of a Method for Early Diagnosis of Cancer Efficacy of Fecal Occult Blood Screening Human Papilloma Virus(HPV)-DNA Hybridization in Early Detection of Genital Cancers In Vivo X-Ray Spectroscopic Mammography Community Oncology and Management Studies (7): Personal and Social Resources in Children with Cancer Prevention of Functional Loss: a Postmastectomy Study Behavior Therapy for Anticipatory Chemotherapy Side Effects Behavioral Interventions for Anticipatory Nausea/Vomiting Factors Influencing Nurses' Role in Breast Cancer Control Objective Measures and Gastrointestinal Morbidity Reduction Reasons to Withhold/Modify Adjuvant Cancer Therapy Field Applications Studies (7): Assessment of Community Resources for Cancer Detection Potential for Cancer Control Through Golden State Medical Association Members Institutional Determinants of Variability of Patterns-of-Care Determinants of Respirator Use Among Spray Painters Cervical Cancer Control: Adequacy of Follow-up Care Cervical Cancer Screening in an Inner City Emergency Room Computer Aided Assessment: Trial in a Breast Cancer Clinic