Full Text PAS-96-027 DEVELOPMENTAL AND GENETIC DEFECTS OF IMMUNITY NIH GUIDE, Volume 25, Number 4, February 16, 1996 PA NUMBER: PAS-96-027 P.T. 34 Keywords: Immunology PHYSIOLOGICAL/DEVELOPMENT PROCESS Genetics National Institute of Child Health and Human Development The Jeffrey Modell Foundation Application Receipt Dates: June 1, October 1, 1996 and February 1, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH), in collaboration with the Jeffrey Modell Foundation (JMF), invites investigator-initiated research grant applications for basic studies to identify the genes and elucidate the molecular and genetic mechanisms that are responsible for normal and defective development of the fetal, neonatal, and infant/child immune system. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Developmental and Genetic Defects of Immunity, is related to the priority areas of maternal and infant health, and immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) from the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) award. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT The mechanisms of support will be investigator-initiated research project grant (R01) and FIRST (R29) awards. Applications for FIRST Awards and R01s from new investigators are particularly encouraged. The total project period for an application submitted in response to this PA may not exceed five years; and a foreign application may not request more than three years of support. FUNDS AVAILABLE The estimated funds available for the total (direct and indirect) first-year costs of all awards made under this PA, for applications assigned to the NICHD, will be $500,000 ($400,000 from the NICHD and $100,000 from the JMF). In Fiscal Year 1997, the NICHD and the JMF plan to fund two to three R01 and/or R29 grants. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. The usual PHS policies governing grants administration and management, including indirect costs, will apply. Although this program is provided for in the financial plans of the NICHD and the JMF, awards pursuant to this program announcement are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. New applications submitted for the June 1 and October 1, 1996 and February 1, 1997 receipt dates will be eligible for funding under this announcement. Competing continuation applications for already funded projects will NOT be eligible for awards from NICHD and JMF under this PA. Although the NICHD has a continuing interest in the research areas of this PA, the latest anticipated award date with set-aside funds is September 30, 1997. RESEARCH OBJECTIVES Background An important mission of the NICHD is to conduct and support basic, clinical and translational research on birth defects. This includes basic research in developmental genetics and developmental immunology. Of particular interest to NICHD are studies that focus on the ontogeny of immunity and the genetic defects that give rise to inherited or primary immune deficiencies. Currently, more than 70 primary immunodeficiencies of varying phenotypes and severity have been described. It has been estimated that approximately 500,000 individuals in the United States are affected, mostly with a mild form. There are, however, 5,000-10,000 individuals, primarily infants and young children, with a severe, life-threatening form. Because long term and/or intensive treatments are required, the total medical, economic, and emotional impact on society is enormous. Recently, more defective genes causing immunodeficiency have been identified, cloned, and characterized. However, they represent a small percentage of the many defective genes responsible for primary immunodeficiencies. Moreover, the cellular, biochemical, genetic, and molecular bases and mechanisms underlying most of the primary immunodeficiencies have not been elucidated. In recent years, the rapid advances in molecular biology and molecular genetics provide the opportunity and technology for identifying the defective genes and for elucidating the abnormal genetic processes that cause the immunodeficiencies. These advances will also provide important information on normal genes and their role and function in the development of the immune system. Previous studies of naturally-occurring human and experimentally-induced animal "knockouts" have been extremely beneficial for identifying defective genes and studying the mechanisms and factors in normal and defective immune development. One goal of this program announcement is to encourage basic research that will lead to new and improved diagnostic, therapeutic, and preventive strategies for primary immunodeficiencies. This program announcement was stimulated in part by a workshop on the "Molecular Mechanisms of Primary Immunodeficiencies," which was sponsored by the Developmental Biology, Genetics and Teratology Branch of the NICHD. The workshop revealed important gaps in our knowledge and promising new opportunities and approaches for research in the molecular and genetic mechanisms of normal immune system development and primary immunodeficiencies. The workshop was sponsored partially by the JMF. The JMF is a non-profit research foundation devoted to primary immune deficiency. It sponsors symposia and workshops; supports research and training; and provides diagnostic, clinical, informational, and educational services on primary immunodeficiency disorders. The JMF was established by Vicki and Fred Modell in memory of their son Jeffrey, who died in 1986, at the age of 15, of an inherited immune deficiency. Scope The objective of this PA is to encourage and promote new and innovative research and approaches to identify the genes and elucidate the molecular and genetic mechanisms responsible for normal and defective development of the immune system. The following are examples of research topics that are appropriate for this PA; however, they are not to be considered as exclusive or limiting: o Identify, clone, and characterize the genes important in the normal ontogeny of the immune system as well as those mutant genes which cause immunodeficiency. o Elucidate the cellular, biochemical, molecular and genetic mechanisms underlying normal and defective development of the immune system. o Identify and characterize genes encoding specific proteins that are critical for normal immune system development; identify those mutant genes that alter expression of specific proteins and result in defective immune system development and immunodeficiency. o Identify and characterize the genes and proteins involved in cytokine-receptor signalling pathways; elucidate the molecular mechanisms of signal transduction that are important in normal and defective immune system development. o Identify and characterize X chromosome genes and their products that are important for development of the immune system. o Identify MHC molecules and their genes that are important in immune system development; and conversely, identify genetic mutations that cause defects in the expression of MHC and defective immune system development. o Develop animal models (natural and/or experimental) that will be useful for studying the genes and genetic mechanisms responsible for primary immunodeficiencies. Applications submitted in response to this PA should focus on identifying the genes and elucidating the basic mechanisms responsible for normal development of the immune system and primary immunodeficiencies. The areas of interest listed above are not in any order of priority. They are only suggested examples of areas of research to consider. Applicants are encouraged to propose other areas that are related to the objectives and scope of this PA. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508- 14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted on the standard application deadlines as indicated in the application kit. Requests for continued funding of already funded projects (Type 2) will NOT be considered under this program announcement. Applications may be submitted for the following receipt dates only: June 1, October 1, 1996 and February 1, 1997. Awards resulting from this program announcement will be made on or about April 1, July 1, and September 30, 1997. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: girg@drgpo.drg.nih.gov. For identification purposes, in item 2 of the application face page, check the box marked "YES" and type in the number and title of this program announcement. The completed original and five legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (For express mail/courier service) FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the Center as a resource for conducting the proposed research. If so, a letter of agreement from the GCRC Program Director must be included in the application material. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Applications assigned to the NICHD will compete for available set-aside funds provided by the NICHD and the JMF. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, program priority and balance among research areas of the program announcement, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct programmatic inquiries to: Allan Lock, D.V.M. Developmental Biology, Genetics and Teratology Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B01, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-5541 FAX: (301) 402-4083 Email: LockA@HD01.NICHD.NIH.GOV Direct fiscal inquiries to: Mr. E. Douglas Shawver Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: ShawverD@HD01.NICHD.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865 - Research for Mothers and Children. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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