===================================================================== == -- ALS INTEREST GROUP -- == == ALS DIGEST (#25, 18 FEB 93) == == To subscribe, unsubscribe, contribute notes, request back == == issues, etc., please send e-mail to: == == bro@huey.met.fsu.edu (Bob Broedel) == ===================================================================== -------------------------------------------------------------------- Date : 17 Feb 1993 17:35:53 -0500 (EST) From : "Malcolm (Tom) Sanford, Florida Extension Apiculturist" : Subject : For your information To : bro@huey.met.fsu.edu ----------------------------------------------------------------- From : IN%"RESEARCH@TEMPLEVM.BITNET" : "Research news from Temple University" 17-FEB-1993 16:45:38.79 Subj : NIH GUIDE - V22(07) 02/19/93 - P2/2 ----------------------------------------------------------------- Date : 17 Feb 1993 16:44:46 -0500 (EST) From : V2153A@TEMPLEVM.BITNET Subject : NIH GUIDE - V22(07) 02/19/93 - P2/2 Sender : Research news from Temple University Comments: Originally-From: Becky Duvall Comments: Warning -- original Sender: tag was NIHGDE-L@JHUVM Part 2 of 2 - NIH Guide 2/19/93 RFAs listed will be available via ftp shortly. ----------------------------Original message---------------------------- $$XID NIHGUIDE 19930219 V22N07 P2O2 ************************************ This program is described in the Catalog of Federal Domestic Assistance, No. 93.838. Grants will be awarded under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-410, as amended: 42 USC 241) 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 intergovernmental review requirements of Executive Order 12372 or to review by a Health Systems Agency. AMYOTROPHIC LATERAL SCLEROSIS NIH GUIDE, Volume 22, Number 7, February 19, 1993 PA NUMBER: PA-93-54 P.T. 34; K.W. 0715140, 1002004, 0785055, 0755030, 0780015, 0755020 National Institute of Neurological Disorders and Stroke PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS) invites research grant applications seeking support of a wide spectrum of research directed at generating improved knowledge concerning amyotrophic lateral sclerosis (ALS). ALS is a progressive fatal neuromuscular disease, the prototype and most common disorder in the class of motor neuron diseases. In this disorder of unknown cause, motor neurons of the brain and spinal cord degenerate, leading to muscle atrophy and progressive paralysis. Subtypes of the disease are defined by location of damage, as in progressive bulbar palsy, or preferential involvement of upper or lower motor neuron, as in primary lateral sclerosis or spinal muscular atrophy. There is no known treatment that will prevent, reverse, or otherwise alter the course of the disease. The basic pathogenetic mechanisms of the disease are also unknown. On a worldwide basis, ALS affects five to seven persons per 100,000. The disease strikes about 1.5 times as many men as women. It is estimated that some 13,000 to 20,000 Americans have ALS. Five to ten percent of all cases are familial, usually inherited in an autosomal dominant pattern, and affect roughly half of family members. Prevalence studies indicate about 5,000 new cases of ALS in the U.S. each year. The most common form of ALS in the U.S. is sporadic. Familial and sporadic ALS are clinically undistinguishable. The disease commonly strikes in the fifth through seventh decades of life, although cases in young adults and in the elderly are well recognized. The average duration of life after onset of symptoms of ALS is three years, encompassing a progressive course of increasing disability. Ninety percent of patients die within five years. Progress and achievements in brain and nervous system research culminated in the Congressional House resolution and Presidential Proclamation declaring the Decade of the Brain (1990s). NINDS's Implementation Plan pointed out unsolved problems, and offered recommendations for significant and profitable research areas to pursue. In support of these recommendations, NINDS is issuing this program announcement soliciting grants from individuals in all disciplines for support of research into the etiology and pathogenesis of ALS, and in research areas that are directly and indirectly relevant to ALS. 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, Amyotrophic Lateral Sclerosis, is related to the priority area of chronic disabling diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic institutions, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority institutions, minority individuals, and women are particularly encouraged. Foreign institutions are eligible for research project grants (R01) and individual National Research Service Awards (F32) only. Only citizens and permanent U.S. residents may apply for K04, K08, F32, and T32 awards. MECHANISM OF SUPPORT Research support may be requested through application for an individual investigator-originated research project grant (R01). Applications from new investigators who have not received previous PHS research grant support may apply for a First Independent Research Support and Transition (FIRST) award (R29). To apply for the support of a more broadly based multidisciplinary research program, the research program project (P01) mechanism is suggested. NINDS also provides support for the career development of clinical investigators through Clinical Investigator Development Award (K08), and development of young scientists through Research Career Development Awards (K04), Individual National Research Service Awards (fellowships) (F32), and Institutional National Research Service Awards (T32). RESEARCH OBJECTIVES The etiology of ALS is unknown. There is no effective treatment for this disease. Clinical features of the disease are well described. A number of pathological, biochemical, and electrophysiological abnormalities are recognized in affected patients and appreciated in post-mortem nervous tissues. Markers for genes in familial ALS, both dominant and recessive, have been found, but they represent only a portion of the possible gene loci. Further genetic studies of ALS linked to other chromosomes are needed. There is opportunity for increased research effort on the abnormal biology of the affected motor neuron, on CNS response to endogenous and environmental toxins, and on identification of metabolic, endocrine, and immunological abnormalities. There is an urgent need for expansion of research on development of new approaches to therapy and the creation of useful new animal models. Because of scarcity of information on mechanisms of the disease, the NINDS encourages individuals from all relevant disciplines to submit grant applications. Examples of research goals, many of which could be studied in humans as well as animal models and tissue culture, and appropriate for pursuing an application in response to this announcement, include, but are not limited to: o Continuation and expansion of the studies of the natural history of the disease. Studies of the ALS patient may shed light on potential environmental and other cause(s) of the disease. Studies of other disorders of motor neurons which may simulate ALS and shed light upon its variants in cause and expression. o Studies of involvement in the etiopathogenesis of ALS of endogenous agents, such as excitatory amino acids, and exogenous agents, such as environmental or occupational toxicants. o Identification and mechanistic studies of chemical agents which protect motor neurons after injurious procedures or exposures; identification and characterization of novel neurotrophic factors that promote neuronal development, neuronal survival, recovery, and repair. These studies may be relevant to our understanding of ALS and development of potential new therapies. o Identification and characterization of genes involved in ALS. Some familial forms of ALS have been linked to chromosome 21, and it is likely that involvement of other genes may be identified as well. o Cell biological studies of the motor neuron, as well as other nervous and non-nervous system cells. Specifically, identification and characterization of molecules expressed exclusively or preferentially on or by motor neurons, and elucidation of their function, and possible relevance to ALS. o Studies of anterograde and retrograde axonal and transsynaptic transport, seeking specific carriers, receptors, or ion channels specific to motor neurons that could explain cause(s) of the motor neuron's selective vulnerability in ALS. o Experimental therapeutic research and conduct of well designed controlled clinical trials. o Establishment of immortalized cell lines with motor neuron specific properties. o Development of new experimental animal models of the disease. Identification and description of natural animal models of ALS could be especially beneficial in generating model systems for therapeutic intervention, and would allow the conduct of pathophysiological and experimental studies otherwise impossible to perform in humans. o Epidemiological and demographic studies of ALS, especially of high risk populations. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study. Special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders, and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaska Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders, or conditions, including, but not limited to, clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed and the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES To apply for R01, R29, P01, K04, K08, and T32 grant applications, form PHS 398 (rev. 9/91) is to be used, and for F32 form PHS 416-1 is to be used. Additional instructions and substitute pages are included with the PHS 398 kit for K04 and T32. Application receipt dates for R, K, and P grants are: February 1, June 1, October 1; for T grants: January 10, May 10, September 10; and for F grants: April 5, August 5, December 5. "NINDS Application Guidelines for Program Project (P01) and Center (P50) Grants" (rev. 4/92), and guidelines for K awards are available upon request from the Program Administrator identified below. Application kits are available at most institutions office of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 496-7441. On the first (face) page, item 2a, of the application, the word "yes" must be checked and the title and number of the announcement typed in the space provided: "Amyotrophic Lateral Sclerosis" PA-93-54. The original and five copies of the PHS 398 application or two copies of PHS 416-1 must be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of collaboration from the GCRC Program Director or Principal Investigator should be included with the application. REVIEW CONSIDERATIONS Applications received under this PA will be assigned to the Initial Review Group (IRG) in accordance with established PHS referral guidelines. The IRGs, which are composed primarily of non-federal scientific and technical experts, will review the applications for scientific and technical merit. Following IRG review, the applications will receive a second-level review by one or more appropriate advisory councils. AWARD CRITERIA The standard review criteria will be used to assess the scientific merit of applications. Applications will compete for available funds with all other applications. The following will be considered when making funding decisions: o Quality of the proposed projects as determined by peer review; o Availability of funds; o Program balance among research areas. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. A. P. Kerza-Kwiatecki Division of Demyelinating, Atrophic, and Dementing Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 804 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-1431 FAX: (301) 402-2060 Direct inquiries regarding fiscal matters to: Ms. Laura Williams Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.853 and 93.854. 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. $$P1 END ************************************************************ ++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ Tom Sanford Extension Apiculturist University of Florida Mailing Address: Bldg 970, Hull Rd., Gainesville, FL 32611-0620 Voice phone 904/392-1801, Ext. 143 FAX 904/392-0190 INTERNET: MTS@GNV.IFAS.UFL.EDU BITNET: MTS@IFASGNV +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++ == end of als 25 ==