kristoff@NET.BIO.NET (Dave Kristofferson) (10/11/89)
Vol. 18, No. 35, October 6, 1989 DATED ANNOUNCEMENTS (RFPs AND RFAs) STUDY OF STEROID CONTRACEPTIVES AND NEOPLASIA (Sources Sought) .(84/118)..... 1 National Institute of Child Health and Human Development Index: CHILD HEALTH, HUMAN DEVELOPMENT THE ROLE OF THE PLACENTA IN TRANSMISSION AND TREATMENT OF HIV INFECTION IN THE NEWBORN (RFA) ......................(121/177, 324/552)...... 1 National Institute of Child Health and Human Development Index: CHILD HEALTH, HUMAN DEVELOPMENT ONGOING PROGRAM ANNOUNCEMENTS NATIONAL RESEARCH SERVICE AWARDS FOR INSTITUTIONAL RESEARCH TRAINING IN HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) .........................(183/230).......... 2 Alcohol, Drug Abuse, and Mental Health Administration Index: ALCOHOL, DRUG ABUSE, MENTAL HEALTH NATIONAL RESEARCH SERVICE AWARDS FOR INDIVIDUAL FELLOWS IN HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) ..........................................(241/286).......... 3 Alcohol, Drug Abuse, and Mental Health Administration Index: ALCOHOL, DRUG ABUSE, MENTAL HEALTH DATED ANNOUNCEMENTS (RFPs AND RFAs) STUDY OF STEROID CONTRACEPTIVES AND NEOPLASIA SOURCES SOUGHT SYNOPSIS: NICHD Contract N01-HD-52901 P.T. 34; K.W. 0750020, 0760085, 0715035, 0755018 National Institute of Child Health and Human Development The National Institute of Child Health and Human Development is planning to negotiate an increase in the requirements of contract N01-HD-52901 with the Fred Hutchinson Cancer Research Center, Seattle, Washington, using other than full and open competition. The contract currently involves the initial analysis and interpretation of data from the World Health Organization Study of Neoplasia and Steroid Contraceptives (WHO Study), on the relationship between the use of oral contraceptives and other steroid contraceptives (primarily depo-medroxyprogesterone acetate), and the occurrence in women of cancer of the breast and reproductive tract, i.e., the endometrium, ovary and cervix. The Government intends to expand the data analysis efforts to include additional analyses of this data set for topics of interest. The effort involved is expected to require approximately 3 person-years. The determination to use other than full and open competition will be made in accordance with 41 USC 253 (c) (1) as set forth in FAR 6.302-1. The proposed source, by virtue of their understanding and utilization of this data during the course of the current contract, has developed the expertise and has sole access to the WHO Study data. The purpose of this synopsis is to determine whether there are other sources with the requisite qualifications to perform the work described above. Organizations who believe they are qualified to perform this shall provide capability statements within 45 days of publication of this synopsis to the following address: Contracts Management Section, NICHD National Institutes of Health Executive Plaza North, Room 610 6130 Executive Boulevard Rockville, Maryland 20852 THE ROLE OF THE PLACENTA IN TRANSMISSION AND TREATMENT OF HIV INFECTION IN THE NEWBORN RFA AVAILABLE: 89-HD-10 P.T. 34; K.W. 1002034, 0413002, 0715008, 0715125, 0403020, 0710070 National Institute of Child Health and Human Development Application Receipt Date: January 17, 1990 The National Institute of Child Health and Human Development (NICHD) invites grant applications to support basic research on the role of the placenta in transmitting infection from mother to infant and its role in potential in utero therapies for HIV infection. The research areas may include but are not limited to: (1) leucocyte antigen immunohistochemistry, in situ hybridization and electron microscopy of the placenta to identify virus infected cells or other cells that may be infected by HIV and/or play a role in transport of the virus from mother to infant; these tests should be correlated with newborn HIV infection to determine the predictive value of viral antigen detection; (2) studies of the role of maternal antibody(ies) in blocking the transmission of HIV infection from mother to infant; (3) leucocyte antigen immunohistochemistry, in situ hybridization and electron microscopy of the products of conception to understand the timing of fetal exposure to HIV and determine the risk of fetal infection; (4) studies of the pharmacokinetics of antiretroviral and other chemotherapeutic agents across the placenta to the fetus to determine the success of transport, efficacy and risk of teratogenesis; (5) gross morphologic and histologic analyses of the effect of HIV infection on placental development and function. Inclusion of women and minorities are encouraged. If they are excluded, reasons for this exclusion must be included in the application. MECHANISM OF SUPPORT Support will be available through the traditional research grant (RO1). Support for grants is contingent upon receipt of appropriated funds. It is anticipated that four to six meritorious applications will be funded. Vol. 18, No. 35, October 6, 1989 - Page 1 APPLICATION PROCEDURE Application must be submitted on form PHS 398 (revised 10/88). ADDITIONAL INFORMATION Potential applicants are encouraged to request further information by telephoning: Pamela Stratton, M.D. Pediatric, Adolescent, and Maternal AIDS Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development EPN, Room 630-P 6130 Executive Boulevard Rockville, Maryland 20892 Telephone: (301) 496-7339 ONGOING PROGRAM ANNOUNCEMENTS NATIONAL RESEARCH SERVICE AWARDS FOR INSTITUTIONAL RESEARCH TRAINING IN HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) P.T. 44; K.W. 0715008, 0720005, 0404003, 0404009, 0715095 Alcohol, Drug Abuse, and Mental Health Administration The National Institute on Drug Abuse (NIDA) is initiating a new program in AIDS and HIV-related research and along with the National Institute of Mental Health (NIMH) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA), seek applications for research training in the areas of mental health, alcoholism and drug abuse as related to the HIV syndrome. The applicant institution must have the staff and facilities to conduct the proposed research training and in a suitable environment for performing high quality work. Awards for institutional grants may be made for project periods of up to five years. In FY l990, a total of $600,000 (NIDA), $2,507,000 (NIMH), and $338,000 (NIAAA) will be available for institutional and individual NRSAs related to HIV. Availability and amount of funds for future years are contingent upon annual appropriations. NIDA, NIMH, and NIAAA will accept applications in response to this announcement under the Public Health Service receipt dates for NRSA applications: May 10, September 10, January 10. Potential applicants may also wish to see the NIDA/NIMH/NIAAA announcement in this issue for individual fellowships. Potential applicants interested in obtaining further information should contact: Charles Sharp, Ph.D. Chairman, Fellowship/Training National Institute on Drug Abuse Room l0A-31 Telephone: (301) 443-6300 Ellen S. Stover, Ph.D. AIDS Coordinator National Institute of Mental Health Room 17C-04 Telephone: (301) 443-7281 David Lozosky, M.D., Ph.D. AIDS Coordinator National Institute on Alcohol Abuse and Alcoholism Room l4C-20 Telephone: (301) 443-4223 The mailing address for all of the above is: 5600 Fishers Lane Rockville, Maryland 20857 Vol. 18, No. 35, October 6, 1989 - Page 2 NATIONAL RESEARCH SERVICE AWARDS FOR INDIVIDUAL FELLOWS IN HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) P.T. 22; K.W. 0715008, 0720005, 0404003, 0404009, 0715095 Alcohol, Drug Abuse, and Mental Health Administration The National Institute on Drug Abuse (NIDA) is initiating a new program in AIDS- and HIV-related research and along with the National Institute of Mental Health (NIMH) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA), seek applications for research training in the areas of mental health, alcoholism and drug abuse as related to the HIV syndrome. Applicants must propose research training in specified areas and demonstrate that the proposed program offers them an opportunity to use and enhance their skills and knowledge. In FY l990, a total of $600,000 (NIDA), $2,507,000 (NIMH), and $338,000 (NIAAA) will be available for institutional and individual NRSAs related to HIV. Availability and amount of funds for future years are contingent upon annual appropriations. NIDA, NIMH, and NIAAA will accept applications in response to this announcement under the Public Health Service receipt dates for NRSA applications: May 10, September 10, January 10. Potential applicants interested in obtaining further information should contact: Charles Sharp, Ph.D. Chairman, Fellowship/Training National Institute on Drug Abuse Room l0A-31 Telephone: (301) 443-6300 Ellen S. Stover, Ph.D. AIDS Coordinator National Institute of Mental Health Room 17C-04 Telephone: (301) 443-7281 David Lozosky, M.D., Ph.D. AIDS Coordinator National Institute on Alcohol Abuse and Alcoholism Room l4C-20 Telephone: (301) 443-4223 The mailing address for all of the above is: 5600 Fishers Lane Rockville, Maryland 20857 Vol. 18, No. 35, October 6, 1989 - Page 3 FULL TEXT OF RFAs FOR ONLINE ACCESS THE ROLE OF THE PLACENTA IN TRANSMISSION AND TREATMENT OF HIV INFECTION IN THE NEWBORN RFA-89-HD-10 P.T. 34; K.W. 1002034, 0413002, 0715008, 0715125, 0403020, 0710070 National Institute of Child Health and Human Development Application Receipt Date: January 17, 1990 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites grant applications to support basic research on the role of the placenta in transmitting infection from mother to infant and its role in potential in utero therapies for HIV infection. The research areas may include but are not limited to: (1) leucocyte antigen immunohistochemistry, in situ hybridization and electron microscopy of the placenta to identify virus infected cells or other cells that may be infected by HIV and/or play a role in transport of the virus from mother to infant; these tests should be correlated with newborn HIV infection to determine the predictive value of viral antigen detection; (2) studies of the role of maternal antibodies in blocking the transmission of HIV infection from mother to infant; (3) leucocyte antigen immunohistochemistry, in situ hybridization and electron microscopy of the products of conception to understand the timing of fetal exposure to HIV and determine the risk of fetal infection; (4) studies of the pharmacokinetics of antiretroviral and other chemotherapeutic agents across the placenta to the fetus to determine the success of transport, efficacy and risk of teratogenesis; (5) gross morphologic and histologic analyses of the effect of HIV infection on placental development and function. NICHD encourages all proposals which in any way scientifically examine and define the role of the placenta in transmission of HIV infection from mother to fetus or the role of the placenta in the in utero treatment of HIV infection in the fetus. DISCIPLINES AND EXPERTISE Among the relevant expertise and disciplines that may be appropriate for inclusion in this program are: obstetrics, obstetric infectious disease, virology, immunology, pathology, pediatrics, cell biology and pharmacology. ADMINISTRATIVE BACKGROUND The Pediatric, Adolescent and Maternal AIDS (PAMA) Branch of NICHD supports research on the epidemiology, natural history, pathogenesis, clinical manifestations, and treatment of HIV infection [including acquired immunodeficiency syndrome (AIDS)] in pregnant women, neonates, infants, children and adolescents. The Center for Research for Mothers and Children (the program of NICHD in which the PAMA Branch is located) held a conference on Research Issues in Pediatric HIV disease in 1988. One of the areas of research interest identified at that conference was the role of the placenta in transmission to and treatment of HIV infection in the fetus. In particular, little information exists on the mechanism for transmission of the virus from mother to fetus and the transport of drugs potentially useful in HIV therapeutics across the placenta. The PAMA Branch seeks to strengthen the research effort directed to a better understanding of the role of the placenta in the transmission and treatment of HIV infection. RESEARCH SCOPE The general scope of research considered by this Request for Applications (RFA) is delineated above in the PURPOSE section. Research on other entities or concepts not previously mentioned that may be involved in elucidating the role of the placenta in transmission and treatment of HIV infection may be included in this RFA. --Special requirements may be necessary for some of these studies to follow and confirm HIV infection in children born to HIV infected women. --Collaboration with ongoing studies of maternal-fetal transmission are encouraged where possible and useful. ASSIGNMENT OF APPLICATIONS All grant applications will be received by the Division of Research Grants (DRG) and assigned to NICHD by the staff of DRG. MECHANISM OF SUPPORT Support for this program will be through the traditional research grant (R01). Policies that govern grant-in-aid award programs of the Public Health Service will prevail. The support of grants pursuant to this RFA is contingent upon ultimate receipt of appropriated funds for this purpose. The number of awards will be influenced by the overall merit of the proposals, by their relevance to program goals, and by the amount of funds available to the Institute. It is anticipated that four to six meritorious applications will be funded. After the awarded projects are underway, meetings meant to foster communication and sharing of information of work in progress will be held. Principal and co-investigators will be encouraged to attend one two-day meeting per year in Bethesda, MD, and funds for that purpose should be included in the application's budget. REVIEW CRITERIA AND PROCEDURES Applications will be reviewed by NICHD for responsiveness to the scope of the RFA. Non-responsive applications will be returned to the applicant. In those cases, the applicant may resubmit the application to DRG and have it assigned as any other unsolicited grant application during the next review cycle. An application will also be considered non-responsive to the RFA if it is identical to one already submitted to NIH for review, unless the previous application is withdrawn. Responsive applications to the RFA will be reviewed within six months of receipt. They may be subjected to a triage by a peer-review group to determine their scientific merit relative to other applications received in response to this RFA. After the triage, NIH will withdraw from competition those applications judged to be noncompetitive and notify the applicant and institutional grant official. Applications judged to be competitive, however, will be evaluated for scientific/technical merit by a review panel convened solely for this purpose by the Scientific Review Program, NICHD. Inclusion of women and minorities are encouraged. If they are excluded, reasons for this exclusion must be included in the application. Criteria for the initial review include: *the significance and originality of research goals and approaches; *the feasibility of research and adequacy of experimental design; *the research experience and competence of the investigator(s) to conduct the proposed work; *the adequacy of investigator's effort devoted to the project; *the appropriateness of the project duration and cost relative to the work proposed. Following review by the Initial Review Group, applications will be evaluated by the Institute's Advisory Council for program relevance and policy issues before awards are made. After scientific review, other Institutes may participate in co-funding meritorious applications received in response to this RFA. The anticipated award date is July 1, 1990. METHOD OF APPLYING Applications should be submitted on form PHS-398 (revised 10/88) which is available in most institutional business offices or from the Division of Research Grants, NIH (301/496-7441). Applications should be identified by checking the "yes" box in Item 2 of the face page of the application and typing in the words, "In Response to RFA 89-HD-10". THE RFA LABEL AVAILABLE IN FORM 398 MUST BE AFFIXED TO THE BOTTOM OF THE FACE PAGE OF THE ORIGINAL APPLICATION. The signed original (topmost) and twenty (20) copies of the application must be received by the Division of Research Grants by January 17, 1990. Applications should be sent or delivered to: Division of Research Grants AIDS Coordinator National Institutes of Health Westwood Building, Room 9 5333 Westbard Avenue Bethesda, MD 20892 Also send three copies to: Laurance S. Johnston, Ph.D. Deputy Director, Scientific Review Program National Institute of Child Health and Human Development Executive Plaza North, Room 520 Bethesda, Maryland 20892 Applications must be received by January 17, 1990. Late applications will not be accepted. TIMETABLE Application Receipt Date: January 17, 1990 Initial Review Date: March 1990 Review by NICHD Advisory Council: June 1990 Anticipated Award Date: July 1, 1990 Inquiries regarding this announcement may be directed to: Pamela Stratton, M.D. Special Assistant for Obstetrics Pediatric, Adolescent and Maternal AIDS Branch National Institute of Child Health and Human Development Executive Plaza North, Room 630-P Bethesda, MD 20892 301-496-7339 or 7350 This program is described in the catalog of Federal Domestic Assistance No. 13.865, Research for Mothers and Children. Awards will be made under the authority of the Public Health Service Act, Section 302 (42 USC241), and administered under PHS grant policies and Federal Regulations 42 CRF Part 52 and 42 CRF Part 74. This program is not subject to review by a Health Systems Agency.