From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA NOT-97-002 - V26(01) 01/10/97 Date: 16 Jan 1997 14:09:09 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 60 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bm8u5$gfv@net.bio.net> NNTP-Posting-Host: net.bio.net SELF-ONLY HEALTH INSURANCE AND TUITION COSTS ON NIH NRSA POSTDOCTORAL FELLOWSHIP AWARDS -- MODIFIED POLICY NIH GUIDE, Volume 26, Number 1, January 10, 1997 P.T. 34; K.W. 1014006 National Institutes of Health In order to streamline the award of competing National Research Service Award (NRSA) individual postdoctoral fellowships (F32), the NIH hereby modifies the policy regarding payment of self-only health insurance costs articulated in the NIH Guide for Grants and Contracts, Vol. 25, No. 2, February 2, 1996 and again in the Fellowship Guidelines published in Vol. 25, No. 31, September 20, 1996. In these two documents, the NIH stated that beginning with fiscal year 1997 postdoctoral fellowship awards, the NIH would award funds to offset 100 percent of the first $2000 and 60 percent of expenses above $2,000 that are associated with the combined cost of tuition, fees, and self-only health insurance. Because few postdoctoral fellows incur educational costs and self- only health insurance costs are routine and fairly predictable, the NIH has elected to increase the institutional allowance by $1,000 to partially offset the cost of self-only health insurance. Incorporating these costs into a fixed allowance will significantly streamline the issuance of fellowship awards while retaining consistency with the recommendations of the NIH Task Force on NRSA Tuition Policy (this report can be found on the World Wide Web at http://www.nih.gov/grants/oep/tuition.htm). Postdoctoral fellows will still be able to request additional funds for tuition and fees associated with specific courses using the formula stated above. Beginning with competing postdoctoral fellowships awarded in fiscal year 1997, the NIH will provide an institutional allowance of $4,000 per 12-month period to non-federal, non-profit sponsoring institutions to help defray such awardee expenses as self-only health insurance, research supplies, equipment, and travel to scientific meetings. The NIH will provide up to $3,000 for fellows sponsored by Federal laboratories or for-profit institutions for expenses associated with self-only health insurance, travel to scientific meetings, and books. The NIH also will provide additional funds to offset the combined cost of tuition and fees for specific courses, which support the research training experience, at the following rate: 100 percent of all costs up to $2,000 and 60 percent of costs above $2,000. INQUIRIES Inquiries regarding this policy may be directed to: Walter T. Schaffer, Ph.D. Research Training Officer National Institutes of Health 6701 Rockledge Drive, Room 6184 Bethesda, MD 20892-7910 Telephone: (301) 435-2770 FAX: (301) 480-0146 Email: ws11q@nih.gov From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA NOT-97-001 - V26(01) 01/10/97 Date: 16 Jan 1997 14:08:51 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 295 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bm8tj$gej@net.bio.net> NNTP-Posting-Host: net.bio.net TROPICAL MEDICINE AND PARASITOLOGY - NIH EXTRAMURAL REINVENTION PILOT STUDIES NIH GUIDE, Volume 26, Number 1, January 10, 1997 P.T. 34; K.W. 1014006 Office of Extramural Research Division of Research Grants Tropical Medicine and Parasitology Study Section National Institute of Allergy and Infectious Diseases BACKGROUND The information in this notice is primarily directed to applicants, peer reviewers, awardees, and NIH staff in Tropical Medicine and Parasitology (TMP). The National Institutes of Health (NIH) has been designated an Extramural Programs Reinvention Laboratory. A series of experiments have been and are being undertaken in a partnership between the Office of Extramural Research (OER), Division of Research Grants (DRG), and National Institute of Allergy and Infectious Diseases (NIAID) to test ways to simplify and expedite the grant application submission, review, and award processes. This notice describes a series of interrelated pilot studies to (1) test methods for shortening the interval from application submission to grant award and (2) assess methods for reducing the amount of information provided by applicants. THE FIVE INTER-RELATED STUDIES The major objectives of these studies are to: (1) determine if the first and second levels of peer review of grant applications can be completed in a shorter interval of time (as little as four to five months compared with the current eight to eleven months) without loss of quality; (2) determine if less information can be obtained from applicants without impeding the review of applications and award of grants; and (3) assess changes in patterns and levels of effort of NIH staff, peer reviewers, and applicants that would be needed to make these types of changes across the NIH. In addition to the study specific evaluations outlined above, focus groups of applicants, peer reviewers, and NIH staff will be convened to assess this group of interrelated studies. ISSUES 1. NIH ASSIGNMENT OF ALL GRANT APPLICATIONS REQUIRES ABOUT SIX WEEKS. NIH receives about 40,000 grant applications annually. Under the current procedure, a DRG referral officer reviews each application and assigns it both to a study section for review and to one or more NIH Institutes or Centers for potential funding. For standard receipt dates, it takes up to six weeks for the referral officers to complete review and assignment of all applications. Elimination or reduction of this time period would reduce the time interval between receipt of applications and their peer review. 2. PEER REVIEW GROUP ADDRESSES ALL APPLICATIONS AND ISSUES DURING THE MEETING - THIS DELAYS SUMMARY STATEMENT PREPARATION AND LENGTHENS STUDY SECTION MEETINGS. Study section members receive applications for review at least a month before the study section meets. Although designated reviewers complete their reviews and written comments before the meeting, this information is not available to other study section members until the dates of the meeting. Making written comments of reviewers available to all study section members before the meeting could (1) enable a portion of the process to be completed earlier, (2) reduce the duration of study section meetings, (3) focus the meetings on important issues regarding each application, and (4) expedite the preparation and release of summary statements. 3. HUMAN SUBJECTS ASSURANCES AND CERTIFICATIONS ARE REQUIRED TO BE SUBMITTED WITH THE GRANT APPLICATION OR WITHIN 60 DAYS OF ITS SUBMISSION AND PRIOR TO PEER REVIEW). Twenty to 25 percent of research grant applications reviewed by a study section are funded. The time and effort required for applicant institutions to complete Institutional Review Board (IRB) activities for the 70 to 75 percent of applications unfunded may be unnecessary and inefficient. 4. WHEN REVISED APPLICATIONS ARE NECESSARY, ENTIRE APPLICATIONS ARE RESUBMITTED - THIS REQUIRES SUBSTANTIAL APPLICANT TIME AND EFFORT AND DELAYS THE RE-REVIEW OF REVISED (AMENDED) APPLICATIONS. The current process for revision, resubmission, and re-review of grant applications requires all applicants to resubmit entire applications. Generally, this means that revised applications are re-submitted and re-reviewed two review cycles (eight months) later. Applicants who need to address or clarify only minor points are treated the same as applicants who must address significant concerns with extensive revisions of their applications. This delays reconsideration of highly meritorious applications and impedes their potential funding. 5. ADVISORY COUNCILS AND BOARDS PERFORM THEIR SECOND LEVEL OF REVIEW OF GRANT APPLICATIONS AT COUNCIL MEETINGS - THE SUMMARY STATEMENTS FOR MANY SCIENTIFICALLY MERITORIOUS APPLICATIONS ARE AVAILABLE TWO TO THREE MONTHS BEFORE THESE COUNCILS/BOARDS MEET. As a result, applicants must wait to hear whether their applications are to be funded until after the Council meeting. A process for early Council review would enable earlier award of grants. THE PILOT STUDIES Each pilot study is outlined in the following paragraphs. For each, quantitative evaluation measures are identified. In addition to these, an overall evaluation using focus group(s) of applicants, peer reviewers, and NIH staff will be established. The members will be asked to assess effects of these studies on the application, peer review process, and award process and to recommend future directions. STUDY 1: SELF-ASSIGNMENT OF APPLICATIONS TO A STUDY SECTION AND A FUNDING INSTITUTE. Virtually all applications reviewed by the TMP Study Section have historically been assigned to the NIAID for potential funding. The TMP study section reviews applications that propose experimental, epidemiological/field, and clinical studies of parasites and parasitic diseases. Studies of the cellular/molecular biology, biochemistry, genetics, epidemiology, and immunology of these parasites are reviewed as are projects relevant to the diagnosis, pathogenesis, prevention and therapy of parasitic infections. (NOTE: Studies of the vectors of parasitic diseases are reviewed separately by a Special Emphasis Panel and will not be considered as part of this pilot.) During the pilot test, applicants proposing studies in these areas will be able to submit their applications on SPECIAL later receipt dates. It is important that applicants use these special receipt dates; the applications received on these special receipt dates will receive expedited handling by DRG. This will reduce the interval between application receipt and peer review. The following are the SPECIAL delayed receipt dates for all applications (new, competing renewal, revised, and supplements): USE THE SPECIAL INSTEAD FOR RECEIPT DATE OF REGULAR RECEIPT DATES OF March 7, 1997 February 2, 1997 and March 1, 1997 July 8, 1997 June 1, 1997 and July 1, 1997 November 7, 1997 October 1, 1997 and November 1, 1997 Applicants should enter "TMP Pilot" and Institute (almost always "NIAID") after Title: in item 2 of the PHS 398 face page. The original, four copies, and all set of appendices must be sent or delivered to: DR. SUZANNE FISHER REFERRAL SECTION DIVISION OF RESEARCH GRANTS 6701 ROCKLEDGE DRIVE, ROOM 2030 - MSC 7720 BETHESDA, MD 20892-7720 BETHESDA, MD 20817 (for express/courier service) One copy of the application must be sent at the same time to: DR. GERALD LIDDEL REFERRAL OFFICE DIVISION OF RESEARCH GRANTS 6701 ROCKLEDGE DRIVE, ROOM 4186 - MSC 7808 BETHESDA, MD 20892-7808 BETHESDA, MD 20817 (for express/courier service) EVALUATION. Evaluation of Pilot Study results: (1) The number and percent of applicants who submitted on the special receipt dates; and (2) the number and percentage correctly self-assigned to the TMP Study Section and potential funding Institutes. STUDY 2: ELECTRONICALLY-ASSISTED PEER REVIEW The NIAID has developed a World Wide Web-based electronic review system and is testing the system in NIAID-conducted peer reviews. The system allows study section members to submit their electronically-encrypted reviews to a password-secured Web server prior to the Study Section meeting. When all reviews have been submitted, only assigned reviewers, other study section members, and DRG staff can access and consider these reviews. Special measures are taken to eliminate conflict-of-interest by prohibiting members from access to reviews of applications with which they are in conflict. The essential components of the peer review system remain unchanged, and as under current procedures, independent scoring of applications is done by each review at the meeting. The TMP study section will test this system for review of applications received on the special receipt dates of March 7, July 8, and November 7, 1997 for final consideration at the June 19-20 and October 1997 and February 1998 study section meetings. EVALUATION. Evaluation of Pilot Study results: (1) percent of reviewers using the WWW system; (2) percent of critiques finalized via WWW; (3) percent of reviewers adhering to schedules for uploading/responding; (4) time savings at peer review meeting; (5) changes in DRG review workload; and (6) changes in completion schedules for summary statements. STUDY 3: IRB DATA FOR ONLY FUNDABLE APPLICATIONS. Applicants who self-assign for peer review to the TMP study section and for consideration for funding to the NIAID will have the opportunity to defer assurances and certifications for human subjects. NIAID will request this information only from fundable applicants immediately after peer review; NIAID already has a process in place to request needed additional pre-award information. Applicants submitting for the March 7, July 8, and November 7, 1997 receipt dates have the option of deferring submission of the human subjects information. EVALUATION: (1) Number and percentage of applicants who elect not to submit IRB data - i.e., effort saved; (2) time and effort post-peer review to get IRB data from fundable applicants; and (3) delays in award, if any, due to deferred receipt of IRB data. STUDY 4: ABBREVIATED APPLICATION AMENDMENTS At each meeting of study sections, applications ranging from those with substantial scientific merit and to those of limited scientific merit are reviewed. A portion of applications may be identified by the study section as having high scientific merit but needing limited additional information that, if provided, could substantially improve the scientific merit of these applications. The summary statements of applicants so identified by study section will designate that the applicants have the opportunity to prepare brief responses to the critiques. These abbreviated application amendments would be three-to-five pages directly related to questions and concerns raised during the initial review. Further, these applicants could be provided their summary statements soon after the meeting and would have the opportunity to submit their abbreviated amendments directly to the Scientific Review Administrator of the Study Section for consideration at the next meeting of the TMP study section. Applications reviewed on February 13-14 and June 19-20, 1997 will be considered by the study section for eligibility to submit abbreviated applications. Those selected will be given the opportunity to submit the abbreviated amendment if their original application is not funded by the Institute. Abbreviated amendments will be made available by DRG to study section members for re-evaluation at the next scheduled study section meeting. EVALUATION. Evaluation of the abbreviated application process will include: (1) number of applications identified as eligible for abbreviated amendment; (2) number and percent of applicants who elect to submit abbreviated applications; (3) DRG staff time required by abbreviated amendment process; (4) average change in priority score for abbreviated amendment applications vs. full revision applications; (5) number and percent of abbreviated applications funded; and (6) estimated change in time of award date for funding of resubmission. STUDY 5: EXPEDITED COUNCIL REVIEW AND NIAID AWARD OF TMP GRANT APPLICATIONS. NIAID has WWW-based encrypted password-controlled electronic system in place to (1) provide Council members with summary statements for applications within NIAID paylines as soon as they become available and (2) receive Council comments and complete the second level of review. This allows NIAID to make awards to successful applicants earlier than would otherwise be possible. This NIAID WWW-based system (named Council Action) will access information directly from the electronically-assisted peer review (See Study 2 above) for applications within the NIAID payline and provide it to the NIAID Council for early second level of review to minimize the interval between peer review completion and Council second level of review. EVALUATION: (1) Reduction in time interval between study section meeting and Council review of applications; and (2) acceptability to Council members of electronically-assisted peer review information as basis for performing second level of review of grant applications. INQUIRIES Inquiries regarding review and referral may be directed to: Dr. Suzanne Fisher Referral Section Division of Research Grants 6701 Rockledge Drive, Room 2030 - MSC 7720 Bethesda, MD 20892-7720 Email: fys@drgpo.drg.nih.gov Dr. Jean Hickman Tropical Medicine and Parasitology Study Section Division of Research Grants 6701 Rockledge Drive, Room 4178 - MSC 7808 Bethesda, MD 20892 Email: hmj@drgpo.drg.nih.gov Inquiries regarding the coordination of this effort may be directed to: John J. McGowan,Ph.D. Acting Deputy Director National Institute of Allergy and Infectious Diseases Building 31 Room 7A03 Bethesda, MD 20892 Email: jm80c@nih.gov From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-024 - V26(01) 01/10/97 Date: 16 Jan 1997 14:08:33 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 420 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bm8t1$gd8@net.bio.net> NNTP-Posting-Host: net.bio.net SPINAL CORD INJURY: EMERGING CONCEPTS NIH GUIDE, Volume 26, Number 1, January 10, 1997 PA NUMBER: PA-97-024 P.T. 34; K.W. 0705055, 0715027, 0765040 National Institute of Neurological Disorders and Stroke National Eye Institute National Institute of Child Health and Human Development National Institute of Nursing Research Application Receipt Dates: February 1, June 1, October 1 PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS), National Eye Institute (NEI), National Institute of Child Health and Human Development (NICHD), and National Institute of Nursing Research (NINR) invite applications for support of research that will increase our knowledge of the mechanisms that underlie processes of injury and repair in the central nervous system (CNS), including optic nerve and other CNS tracts, and that will provide strategies for therapeutic intervention in spinal cord injury. 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 PA, Spinal Cord Injury: Emerging Concepts, is related to the priority area of unintentional injuries. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign 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. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Applications from minority institutions, minority individuals, and women are particularly encouraged. MECHANISM OF SUPPORT The support mechanisms for grants in this area will be the investigator-initiated research project grant (R01) and the FIRST award (R29). The principal investigator will plan, direct, and, along with any co-investigators, perform the research. Applicants planning to submit a new (Type 1) investigator-initiated grant application requesting $500,000 or more in direct costs for any year must contact institute program staff before submitting the application. A cover letter that identifies the program staff member who agrees to accept the assigned application must be sent with the application. RESEARCH OBJECTIVES Background Injury to the spinal cord tragically affects hundreds of thousands of people in the United States, with approximately 10,000 new traumatic injuries each year. Early treatment and improved hospital care have increased survival, but at great cost. The estimated yearly cost of long-term, specialized care for paralyzed patients exceeds $10 billion. The personal costs to patients and their families is beyond calculation: planned education, career, marriage, and independence are interrupted and often never regained. The spinal cord, as part of the central nervous system (CNS), coordinates movement and sensation for the entire body below the head. Specialized cell populations within the cord are the substrates for these functions. Motoneurons extend long axons peripherally to innervate skeletal muscle. These motoneurons receive information from descending tracts of the brain both directly and indirectly via interneurons in the spinal cord gray matter. Axons of dorsal root ganglion cells connect peripheral sensory receptors to spinal interneurons, to motoneurons, and to brain centers. This complex neuronal circuitry of the spinal cord is supported by the glia of the CNS. Radial glia enclose the cord like the rim and spokes of a wheel, defining compartments for ascending and descending fiber systems. Astrocytes contribute to the blood-spinal cord barrier and provide a wide variety of support functions. Oligodendrocytes myelinate axons, and provide for rapid conduction of neuronal signals. Traumatic injury disrupts all of these cell types and changes their functions. Axons degenerate, neurons die, astrocytes proliferate and become reactive, radial glia enclose large cysts, and oligodendrocytes cannot remyelinate damaged areas. The anatomy of an injured spinal cord shows profound pathology, but also reveals the sprouting of uninjured fibers, the regeneration of damaged populations, the reorganization of glia, and clearing away of debris. The neurophysiology of the spinal cord also changes, reflected by altered responses to stimulation. Without appropriate ascending and descending input, remaining neural circuits change over time, and this plasticity may contribute to permanently impaired function. It is necessary to enhance initial regenerative responses, and much can be learned from developmental neurobiology, where mechanisms that underlie the generation of neural cells and their connections can be examined directly. A number of CNS regions, such as optic nerve, provide accessible and well defined areas to elucidate fundamental mechanisms. Several trophic and inhibitory factors are known to affect survival of neurons and extension of neurites, and naturally occurring substances may enhance supportive glial functions. Components of the extracellular matrix can support the growth of axons. The growing body of knowledge on genetic and cellular mechanisms of survival and growth can be related directly to a variety of injury paradigms to determine the most crucial events in eventual outcome. Clinical issues in spinal cord injury involve the entire person, emotionally and physically, from the time of injury, through acute hospital care, rehabilitation, and life changes. Experimental strategies to minimize damage in the early stages of injury include hypothermia, antioxidants, neurotrophic factors, blockers of excitoxicity, gangliosides, and steroid therapies; however, only one treatment, high dose methylprednisolone, is in current use. Changes in blood volume and maintenance of adequate ventilation during initial treatment are also critical. A myriad of chronic disorders, from spasticity to depression to infection, plague the survivors of spinal cord injury and require management by a variety of health care professionals. An NIH workshop entitled "Spinal Cord Injury: Emerging Concepts" was held in Bethesda, Maryland on September 30- October 1, 1996. Several areas of relevance for further research were presented by the participants, and form the basis for this program announcement. Research Goals and Scope Examples of investigator-initiated research grant applications for basic, applied, and clinical studies related to the understanding of the neurobiology of injury and regeneration may include, but should not necessarily be limited to: o Mechanisms of Secondary Injury and Cell Death. Determine the extent and time course of apoptosis in neuronal and glial populations after trauma. What gene families contribute to programmed cell death after injury in the adult CNS? What genes can contribute to cell survival? What signals activate irreversible pathways and how are these pathways regulated? What are the links between immediate and delayed cell death in the nervous system following injury? To what extent do the various mechanisms (i.e., excitotoxicity, free radicals, cytokines) contribute to overall secondary damage? o Immune Responses. Investigate the temporal profiles of cellular and molecular changes in spinal cord that signal both the afferent and efferent limbs of the immune response. What affects the trafficking of immune cells across the blood/spinal cord barrier? What aspects of the immune response contribute to healing after spinal cord injury? o Cell Generation. Explore the existence and properties of multipotential stem cells that remain in the adult CNS. What signals regulate the proliferation and differentiation of these cells? o Trophic Control Mechanisms. Identify the peptide trophic factors that signal survival and growth of specific types of neurons and their processes. How is production and release of such signals regulated? What confers responsiveness of neurons to trophic stimulation? What receptors and signal transduction pathways are involved? What is the role of electrical activity in neuronal trophic factor production and release? Which trophic signals are made by glial cells, and does neuronal activity regulate this production? Do glial cells from the central versus peripheral nervous system differ in the mechanisms that regulate their production and release of trophic factors? o Axonal Survival and Growth Signals. What is the molecular and cytoskeletal basis of axon growth? Do the same intracellular mechanisms that promote survival of the cell also promote regeneration of the axon, or are novel molecular mechanisms involved? o Axonal Guidance Signals. Elucidate novel chemotropic factors (both soluble and contact-mediated) that guide growing axons, their signaling mechanisms, and receptors. Do CNS and PNS differ in the expression of these axonal guidance molecules? o Axonal Inhibitory Signals. Identify molecules that inhibit axon elongation and characterize their cell type specificity. What extracellular signals induce axons to stop growing during normal development, and how is the signal transduced? Is there cross-talk between inhibitory and stimulatory axonal signals? o Function of Glia and Remyelination. Astrocytes, microglia and oligodendroglia all react to traumatic injury. What is the time course and extent of glial reactivity? To what extent do demyelination and remyelination occur? Do new myelinating cells arise from surviving oligodendrocytes or from precursors found within the CNS? Are interactions among glial populations necessary for myelination? o Synapse Formation. Identify the mechanisms of synapse formation in the central nervous system. What factors contribute to site recognition by growing axons? What postsynaptic characteristics result in permanent and stable synapses? Is the exchange of information between pre- and postsynaptic elements the same in regenerating versus developing synapses? o Functional Plasticity. Design interventions that can enhance or build on intrinsic mechanisms of repair. Can useful recovery of function be achieved by driving the intrinsic rhythm generators of the distal cord? What minimum descending input, both quantitative and qualitative, is required to drive these circuits? Study the potential for adaptive change in the spinal cord that remains after injury. Evaluate the efficacy of neuromodulator or transmitter replacement in terms of modified segmental circuitry. How is motoneuron excitability below a lesion altered? What changes occur in sensory circuits that can contribute to chronic effects after injury? Will rescue of cells that have been damaged improve function? o Neural Prostheses. Investigate the feasibility of using neural prostheses to restore bowel and bladder function, upper and lower extremity functional movement, and upper and lower extremity sensation. Develop new microelectrodes capable of providing chronic ingoing and outgoing connections with sensory and motor neurons in the spinal cord. Investigate biomaterials and bioactive surfaces to permit the integration of neural prostheses with spinal cord tissue. o Chronic Injury and Rehabilitation. Emphasize systematic analyses of rehabilitation as adjuncts to biological or pharmacological treatment of damaged spinal cord. Define "windows of opportunity" for functional repair. Enhance understanding of the neurobiology of the chronically injured cord. Develop improved animal models for both acute and chronic spinal cord and CNS injury. Study therapeutic interventions aimed at the various functional consequences of spinal cord injury such as spasticity and exaggerated reflexes, respiratory compromise, pain, pressure ulcers, bone deterioration, or bowel/bladder control. Investigate issues of nutrition, physical conditioning, and sleep in individuals with spinal cord injury. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should follow the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators 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) according to the instructions included in the application package. These application packages are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, email: ASKNIH@odrockm1.od.nih.gov. Receipt dates for new research grant applications are February 1, June 1, and October 1. On page 1 of form PHS 398, check "YES" in Item 2 and enter the number and title of this Program Announcement in the space provided. Use the mailing label provided in the application package to mail the completed, signed original and five exact copies to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) A number of other Institutes, Centers, and Divisions (ICD) at the NIH may be interested in the general subject of this program announcement. Applications submitted in response to this PA that propose research in scientific areas that overlap ICD interests will receive a funding component assignment in accord with existing referral guidelines and procedures established by the Division of Research Grants, NIH. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. Applications for multicentered clinical trials will be reviewed by the institute designated for primary assignment. The standard review criteria will be used to assess the scientific merit of applications. The second level of review will be by the appropriate National Advisory Council. AWARD CRITERIA 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; and o program balance among research areas. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Mary Ellen Cheung Division of Stroke, Trauma, and Neurodegenerative Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 8A13 Bethesda, MD 20892 Telephone: (301) 496-4226 FAX: (301) 480-1080 Email: MM108W@NIH.GOV Dr. Michael D. Oberdorfer Strabismus, Amblyopia, and Visual Process Branch National Eye Institute 6120 Executive Boulevard, Suite 350, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 496-5301 FAX: (301) 496-0528 Email: MO5R@NIH.GOV Dr. Danuta Krotoski National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 6100, Room 2A03, MSC 7510 Bethesda, MD 20892 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: DK58P@NIH.GOV Dr. Mary D. Leveck Scientific Program Administrator National Institute of Nursing Research Building 45, Room 3AN-12, MSC 6300 Bethesda, MD 20892 Telephone: (301) 594-5963 FAX: (301) 480-8260 Email: MLEVECK@EP.NINR.NIH.GOV Direct inquiries regarding fiscal aspects to: Ms. Gladys Bohler Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 Ms. Carolyn Grimes Extramural Services Branch National Eye Institute Executive Plaza South, Suite 350 Bethesda, MD 20892 Telephone: (301) 496-5884 Ms. Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A07 Bethesda, MD 20892 Telephone: (301) 496-5001 Mr. Jeff Carow Grants Management Officer National Institute of Nursing Research Building 45, Room 3AN12 MSC 6301 Bethesda, MD 20892 Telephone: (301) 594-5974 FAX: (301) 480-8256 Email: JCAROW@EP.NINR.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance Number: 93.853-93.854, 93.868, 93.864- 93.865, and 93.361. Grants will be awarded under the authority of the Public Health Service Act, Title IV, 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 74. This program is not subject to Health Services Agency Review of the intergovernmental review requirements of Executive Order 12372. 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. From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AG-97-002 - V26(01) 01/10/97 Date: 16 Jan 1997 14:09:25 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 787 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bm8ul$gh4@net.bio.net> NNTP-Posting-Host: net.bio.net RESOURCE CENTERS FOR MINORITY AGING RESEARCH NIH GUIDE, Volume 26, Number 1, January 10, 1997 RFA: AG-97-002 P.T. 04, FF; K.W. 0710010, 0745027, 0745035 National Institute on Aging National Institute of Nursing Research Letter of Intent Receipt Date: March 7, 1997 Application Receipt Date: April 18, 1997 PURPOSE The National Institute on Aging (NIA) invites applications from qualified institutions for the creation of Resource Centers for Minority Aging Research (RCMARs). The long-range goal for the RCMARs is to decrease the minority/non-minority differential in health and its social sequelae for older people by focusing research upon health promotion, disease prevention, and disability prevention. More basic or clinical research areas will be considered if there is a clear and compelling rationale that they offer the potential to reduce health status differentials. To meet the long-range goal, RCMARs will create a research infrastructure around three objectives: (1) to establish a mechanism for mentoring researchers for careers in research on the health of minority elders; (2) to enhance diversity in the professional workforce conducting research on the health of minority elders; and (3) to develop and deploy strategies for recruiting and retaining minority group members in epidemiological, psychosocial, and/or biomedical research dealing with the health of the elderly. RCMAR funding is not intended for further description of majority/minority health status or access differentials but for ultimately closing that gap. RCMARs are intended to be broadly multi-disciplinary. Interaction among social, behavioral, and clinical sciences is anticipated and encouraged in order to meet Center objectives. The RCMAR solicitation is intended to meet its objectives by: o increasing learning and mentoring relationships between experienced researchers and researchers without previous funded research on minority health and aging issues; o increasing the research skills and experience of minority faculty at either majority or traditionally minority based institutions (TMBIs) who may not have had opportunities for conducting minority health and aging research; o increasing the cultural awareness, community development techniques, and methodological skills of majority and minority researchers who have limited familiarity with minority populations or with behavioral science/epidemiological research skills in conducting research in minority populations; o supporting research on understanding and reducing health status and access differentials by funding pilot studies which have a high probability of resulting in subsequent independent investigator awards, involving minority researchers as principal investigators (PIs) or major co-investigators; o creating an infrastructure using already tested models for accessing older minority individuals to seek their participation in biomedical, social and behavioral research on aging; o increasing and disseminating knowledge about, and experience with, gaining access to and maintaining populations of various minority group members for aging research; and o creating culturally sensitive strategies and measurement tools for use in older minority populations for aging research. 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. The Request for Applications (RFA), Resource Centers for Minority Aging Research, is related to the priority areas of educational and community-based programs, heart disease and stroke, cancer, diabetes and chronic disabling conditions, and clinical preventive services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and Local governments, and eligible agencies of the Federal government. Awards will not be made to foreign institutions. Applications from racial/ethnic minority individuals, women and persons with disabilities are encouraged. Applicants must demonstrate access to and experience working with the selected minority population(s). Applicants can come from either TMBIs or from other institutions that demonstrate a strong, functional and cooperative arrangement with minority researchers and/or minority organizations. Institutions or affiliates should have prior experience in conducting minority research including skills in social survey or qualitative research techniques and methodologies for recruiting, maintaining, and assessing minority populations. At the time of application, institutions participating as part of a proposed center must have among them at least three or more externally funded, current, peer-reviewed projects involving human subjects in the RCMAR-related areas of reducing health differentials, health care access, and/or minority research, as related to aging research. The projects must be expected to continue for at least a year after the time of application. MECHANISM OF SUPPORT This program will be supported by an NIH Core Center Grant (P30). Applicants must request five years of support. Awards may be renewable at the end of five years through submission of a competing continuation application depending upon progress and the availability of funds. FUNDS AVAILABLE The award of Center grants pursuant to this RFA is contingent upon the availability of funds for this purpose. The intent is to fund up to six RCMARs in Fiscal Year (FY) 1997. The specific number awarded will be contingent upon the merit of the proposals. These applications do not compete for funding within the general pool of dollars available for investigator-initiated research proposals. The total cost may not exceed $575,000 per application for the first year (excluding an elective Coordinating Center component; see below). Years two through five may not exceed a three percent per year increase. Contingent upon funds being available and appropriate progress, RCMARs may be renewable after the initial five year period through submission of a competing continuation application. RESEARCH OBJECTIVES Over the last several years NIA has increasingly focused attention upon: enhancing its commitment to research on topics germane to the health and well-being of older minority Americans; involving minority researchers in minority institutions in aging research and training; and encouraging researchers at TMBIs to participate in nationally funded research on aging and health. Research focusing directly and indirectly upon minority/majority differences in health, health care access and the use of preventive services has lead to increased understanding of these differences (Ferraro and Farmer, 1996; Link and Phelan, 1995; Marquis and Long, 1996; Weissman and Epstein, 1994). However, the involvement of minority researchers in independently funded health care and health promotion research and the involvement and maintenance of minority populations in research projects continues to be an NIA priority and major concern in both social and biomedical research concerning the elderly (Harris et al., forthcoming; Prohaska and Walcott-McQuigg, forthcoming). The creation of RCMARs is intended to continue the effort to close the gap between minority and non-minority populations in health status and health care and to improve understanding of disease and health in older minority populations. This long-range goal can be accomplished by enhancing the capacity of minority and non-minority researchers and TMBIs to conduct research among minority groups. RCMARs are also expected to contribute to the creation and dissemination of knowledge regarding the inclusion and continued participation of minority subjects in studies dealing with the RFA's focus. The recruitment and retention of minority subjects in panels for both social science and clinical/biological research is a central objective in this RFA. These objectives will necessitate the creation of culturally sensitive techniques and measurement tools in ethnically and racially diverse populations. SPECIAL REQUIREMENTS The RCMAR proposal may be submitted by a PI from a TMBI or a non-TMBI. If submitted by a non-TMBI, the PI should be able to demonstrate active involvement of minority researchers at the professional level. Applicants are strongly encouraged to include at least one community based, minority oriented organization as a partner in the RCMAR proposal. At least one of the institutions involved in the RCMAR must have prior experience related to aging research on reducing the differential in health status and/or access among minority and majority populations. The RCMAR will be organized around a series of Core activities. The function of each Core is suggested below; the particular organization of the RCMAR and the interaction among Cores should be described and justified in the application. The proposal should present an identifiable and separate budget for each Core and a description of each Core's approach to the activities outlined in the RCMAR RFA. While four Cores are required, each applicant may propose and justify additional Cores. Administrative Core RCMARs must have strong and experienced central leadership to coordinate proposed activities and to keep all RCMAR components informed of important activities and decisions. Critical elements of the Administrative Core follow. o Leadership by an experienced investigator is essential. The PI must possess experience in conducting research with minority elderly populations. He/she should be experienced in mentoring and learning environments that will enhance the inclusion of minority researchers. o The Administrative Core must propose and show evidence of having recruited an Advisory Panel of at least five, and no more than seven, members including at least two from relevant community groups and two researchers on aging, the latter not otherwise affiliated with the RCMAR. The Advisory Panel will meet at least twice yearly to review Center activities and make recommendations to improve RCMAR functions. o The proposal must specify how the Administrative Core will create mechanisms to ensure that RCMAR Cores will interact to maximum benefit. The objectives of that interaction must be specified. o The proposal's Administrative Core component should specify the mechanisms for ensuring that RCMAR researchers will interact with colleagues at the parent institution and at affiliated institutions, including community organizations. These mechanisms are needed to ensure: (1) the practicability of developing connections with minority communities; (2) recruitment and retention of minority subjects; (3) the viability of mentoring and training relationships among affiliated institutions, when appropriate; and (4) the creation of appropriate instruments and techniques for working with different ethnic/racial groups. o The Administrative Core should specify its role in the oversight of the selection of studies for pilot funding made during the conduct of the RCMAR effort. It must specify how it will facilitate and track the evolution of these studies from pilot to independent investigator, R01-type proposals during and following the five years of the RCMAR. o The Administrative Core will select three participants from the RCMAR and prepare for an annual day and a half meeting in the Washington, DC area to discuss progress and common problems in the conduct of the Centers. Travel to these meetings should be budgeted as part of the Administrative Core. Community Liaison Core Experience indicates that intensive effort, specialized skill, and creativity are needed to recruit and retain older minority subjects. To these ends, it is the responsibility of the Community Liaison Core to develop and maintain relationships with individual minority group members and minority community-based organizations (CBOs). Liaison Core staff are encouraged to work with CBOs to foster acceptance in minority communities for participating and remaining in research projects. The Community Liaison Core's role is to facilitate interaction among individual minority community members including formal and informal leaders, as well as with appropriate CBOs, and with researchers planning studies involving minority communities. To this end, the Community Liaison Core will create and maintain an infrastructure of minority group member participants for research involvement among RCMAR and other research projects at their home institution(s). The Community Liaison Core is encouraged to work closely with both the CBOs and the professional staff who plan and conduct research involving community members. In conjunction with the Investigator Development Core (see below), the Community Liaison Core must create and disseminate information regarding techniques for recruitment and retention of minority subjects suitable for investigators at local institutions and nationally. A plan for dissemination of recruitment and retention methods must be included in the application. It may include publications and presentations of information, conferences and symposia, and outreach activities to other institutions conducting clinical, behavioral, and/or social research on aging. Investigator Development Core It is the responsibility of the Investigator Development Core to assure successful mentoring of, and collaboration with, minority researchers. This function has two components: Pilot Studies and Information Transfer Activities. Pilot Studies Each RCMAR must propose two pilot studies for the first year. Each pilot study should be of no more than one year's duration. Each RCMAR should anticipate funding three to four pilot studies during each subsequent year of the project's five year duration and all pilot studies must involve a minority investigator at the professional level (e.g., as PI or major co-investigator). The pilot studies should provide preliminary data on progress toward: (1) developing or testing clinical, social, and/or behavioral interventions for decreasing differentials in health status or access to services among older minority and majority group members; or (2) developing and validating measurement instruments or protocols suitable for use with minority groups; or (3) testing models of recruitment/retention strategies. In the initial RCMAR proposal, a three page summary (maximum) of each selected pilot study should accompany the proposal. Each summary should contain a PHS standard Biographical Sketch for the investigator, a statement of the problem, the methods to be used, the anticipated results, and subsequent planned efforts leading to an independent investigator award. The RCMAR proposal must include the criteria used for selecting the submitted pilot studies and propose a plan for reviewing pilot grant applications in subsequent years. Applicants should also provide a plan for increasing the number of minority researchers receiving support though pilot projects in the out years of the project. A minimum of three and a maximum of four pilot projects may be supported in each of years 02 through 05. Funding for each pilot study may not exceed $20,000 (direct costs) per year. In years 02 through 05, each RCMAR will be responsible for: o selecting and funding (maximum direct cost: $20,000 for each pilot study) a minimum of three and a maximum of four new pilot investigations in each year; and o demonstrating that prior years' pilot studies lead to the submission of R01 or similar independent research proposals. Each RCMAR must develop and specify plans for disseminating information about the availability of pilot funds. If consistent with the overall objectives of the specific RCMAR, the Center may fund researchers who are not members of the original participating institution(s). It is assumed that such pilot projects might bring in new collaborating partners. Proposed pilot projects in out-years must have the approval of the NIA program administrator. Information Transfer Activities Each RCMAR should create a program for disseminating research information regarding techniques used for conducting research involving minority aging populations. The audiences for these activities should include CBOs and researchers at the host institution as well as investigators at other institutions who are in a position to further enhance the inclusion of older minority populations in research addressing the differential in health status and access to care among older minority and majority populations. Information transfer activities may include, but are not limited to activities such as training programs, short courses, distance learning, presentations at professional meetings and publications. The content of these activities are at the discretion of the RCMAR but should include information on: basic research methodologies; recruitment and retention of minority populations; and substantive issues regarding health care differentials among older minority and majority populations. The RCMAR may wish to seek Continuing Health Education credit for participants. The information transfer function of the Investigator Development Core should work closely with the Community Liaison Core on issues of recruitment and retention. Proposals should describe in detail the plan for developing and evaluating information dissemination activities. The Investigator Development Core must also specify a mechanism for assuring the effective mentoring of minority researchers. The RCMAR proposal should contain a plan for, and an evaluation strategy of, the mentoring process to demonstrate its ability and commitment to enhancing diversity in the professional research workforce dealing with the health of the elderly. Measurement Core Each RCMAR should specify strategies for identifying, cataloging, distributing and/or creating culturally sensitive epidemiologic, or psychosocial measurement tools. Centers should develop and test strategies for enhancing cultural sensitivity in collecting clinical, behavioral, and social science data (e.g., drawing blood; collecting urine; assessing socioeconomic status; conducting qualitative research). It is the responsibility of the Measurement Core to create, identify, catalogue, and disseminate information in its domain. The RCMAR proposal should specify methodologies for these activities. Optional Coordinating Center Each applicant is invited to submit as part of his/her response to the RCMAR RFA, a section proposing a Coordinating Center (CC). A maximum budget for this effort is $150,000 per year (total costs) or should the number of RCMARs funded by less than six, the total budget for the CC will be $25,000 times the number of funded Centers, but not less than $100,000. The selection of the CC will be made by the NIA program administrator based on the recommendations of the Initial Review Group responsible for peer review of the proposals. The CC will fulfill the following functions. Coordinating Center: Logistic Support The CC will provide logistic support to the NIA program administrator and to the RCMARs. It will make all arrangements for a yearly RCMAR meeting in the Washington, DC area (see below), prepare minutes, and in coordination with NIA Program Staff, create the agenda for that meeting. It will also have the responsibility of preparing a yearly progress report for the program. Additionally it will foster communication among Centers, including the NIA. The CC will collect and summarize Advisory Panel minutes from each Center and share those with other sites. Coordinating Center: Data Collection and Dissemination Support The CC will facilitate the sharing of scientific information, techniques, and measurement tools among the Centers. By means of a clearinghouse mechanism, the CC will collect and disseminate these items and encourage shared activities among the Centers including, but not limited to: distance learning, training seminars, dissemination strategies and resources, works-in-progress and techniques for recruitment and retention of aging minority population members. Coordinating Center: Summary Report The CC will work with the NIA program administrator and each Center in preparing a document near the conclusion of the first four years of RCMAR experience summarizing similarities and differences among the Centers. The document will contain, but not be limited to: Center descriptions; common themes; findings regarding the training and recruitment of minority investigators; and findings regarding the recruitment and retention of minority subjects. In addition, the CC will work with the NIA program administrator in planning a national symposium based upon the findings and experience of the RCMAR program. Budget Considerations All RCMAR applicants should request and provide justification for five years of support. The total costs for the first year of support may not exceed $575,000 and years 02 through 05 may not exceed a three percent per year increase. The distribution of funds within the RCMAR to each Core is at the discretion of the applicant institution and must be justified by the activities of each Core. Support for secretarial and administrative staff may be provided to the extent that their activities relate to meeting RCMAR's specified objectives. Similarly, domestic and foreign travel by project personnel must be justified as meeting project objectives. Travel and per diem for three persons to attend an annual day and a half meeting in the Washington, DC area should be included in the budget. Consultants' costs are allowed if evidence is presented that the services are required by the RCMAR's objectives and are not otherwise available. Pilot studies may not exceed $20,000 per pilot, direct costs. The cost justification for each pilot study should be contained in the Investigator Development Core budget. For awarded grants, applications for years 02 through 05 must contain the cost justification for each of the selected pilot studies in the renewal application budget. Funding for specific out-year pilot studies must be approved by the NIA program administrator. INCLUSION OF WOMEN AND MINORITIES It is the policy of the NIH that women and members of minority groups and their subpopulations 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 policy resulted 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. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," published in the Federal Register of March 28, 1994 (FR 59, 14508-14513), and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, MARCH 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. LETTER OF INTENT Prospective applicants are asked to submit, by March 7, 1997, a letter of intent that includes a descriptive title of the proposed RCMAR, the name, address, phone number(s), fax number, and E-mail address of the Principal Investigator, if possible, the identities and professional affiliation(s) of key personnel likely to assume leadership roles of the Cores, and the number and title of this RFA. The letter of intent is not binding and will not enter into consideration in this or subsequent applications. The information is helpful in planning for the review of the applications. It allows NIA staff to estimate the potential review workload, to select reviewers appropriately and to avoid conflicts of interest in the selection of reviewers. The letter of intent is to be sent to Dr. Stahl at the address listed under INQUIRIES. APPLICATION PROCEDURES The application should be prepared using instructions in this RFA and those in supplementary instructions for preparation of multi-component applications available from the program staff listed under INQUIRIES. Prior to submission of the formal application, consultation with NIA Program Staff concerning the technical aspects of preparing the application is strongly encouraged. The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. To identify these applications as being in response to the RFA, check "YES" on item 2 of the face page of the application and enter the RFA number and the title: "RESOURCE CENTERS FOR MINORITY AGING RESEARCH." The RFA label available with the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee on time for review. Submit a signed, original of the application, including the Checklist, and three signed, exact photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Chief, Scientific Review Office National Institute on Aging Gateway Building, Room 2C212 7201 Wisconsin Avenue MSC 9205 Bethesda, MD 20892-9205 Applications must be received by April 18, 1997. If an application is received after that date, it will be returned to the applicant without review. Page Limitation: Applications may not exceed a total of 25 pages for Items a-d of each core. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) and for responsiveness by NIA. Incomplete applications will be returned to the applicant without further consideration. If NIA staff find that the application is not responsive (i.e., fails to include all required components, or requests amounts that exceed allowable limits, or is not directed to the goals of this RFA) it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIA. As part of this merit review, a streamlined review process may be used in which applications will be determined to be competitive or non-competitive based on their merit relative to other applications received in response to the RFA. Applications judged to be competitive will be reviewed in detail by an initial peer review group and also receive a second level of review by the National Advisory Council on Aging. Applications determined to be "non-competitive for funding" will be so designated, and an abbreviated summary report noting the major weaknesses will be sent to the principal investigator and the application withdrawn. Each application must be thorough and complete enough to stand on its own and should be prepared as if no site visit will occur. Additional materials or revisions will not be accepted after the receipt date. It is strongly recommended that Institutional Review Board (IRB) approval be secured prior to submission. Otherwise, it is the applicant's responsibility to ensure these certifications are sent to the Scientific Review Office, NIA, within 60 days of the proposal's receipt date. Applications failing to comply with this requirement will be returned without review. There will be no further notification on this issue. Review criteria Applicants should demonstrate that the following general criteria can be met for this solicitation. o Evidence of experience with, and a commitment to, fostering working relationships with minority populations. o Evidence of the inclusion of minority researchers in the RCMAR proposal. o Evidence of prior research in the areas addressed by this RFA as they relate to minority elderly populations. o Evidence of existing linkages, or a reasonable expectation of such linkages, with minority institutions or community organizations. o Appropriateness of the proposed budget. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. The following criteria will be used in judging the adequacy of the administration of the proposed RCMAR. o Evidence of the scientific, leadership, and administrative ability of the RCMAR Director and his/her staff and a commitment to devote adequate time to program management. o Evidence that the organization and processes proposed for internal communication and cooperation between and among the Cores and community groups will function to meet RCMAR objectives. o Evidence that the mechanisms for review and administration of the pilot studies will function to produce studies that meet substantive objectives and have a reasonable expectation of subsequent independent funding. o Evidence that the Advisory Panel is well linked to the minority population(s) served and to the broader gerontologic research community and is committed to the success of the RCMAR. The following criteria will be used to evaluate the commitment of the host institution(s) to RCMAR objectives. o Evidence that the academic environment(s) and its/their resources, including space, equipment, and facilities, are adequate to meet the RCMAR's objectives. o Evidence that the host institution is sufficiently flexible to foster multi-disciplinary interaction between its administrative units and with organizations external to the university (e.g., CBOs). The following criteria will be used to evaluate the investigators. o Evidence of sustained research and prior successful mentoring experience. o Evidence of commitment to furthering RCMAR objectives through prior professional activity in each of the following areas: (1) creating an infrastructure for increasing minority researcher mentoring; (2) successfully maintaining recruitment goals for minority subjects in prior funded research; (3) conducting research addressing strategies for decreasing minority/non-minority health and/or access differentials in older populations; and (4) development of culturally sensitive assessment methods and tools. Each Core should demonstrate evidence that its functions address the objectives of the proposed RCMAR. The review criteria for the Administrative Core are those of overall program administration and are listed above. The following criterion will be used for evaluating the Community Liaison Core. o Evidence of an ongoing relationship or a reasonable expectation of the ability to create a relationship with minority community groups. The Investigator Development Core will be evaluated using the following criteria. o Evidence of the scientific adequacy, appropriateness (to meet RCMAR objectives), and feasibility of the proposed pilot studies. o Evidence of the intention and likelihood that the proposed pilot studies will result in the submission of a competitive, investigator initiated, independent research award, such as an R01. o Evidence that during the out-years of the Center, there is a sufficient pool of researchers to submit excellent pilot study applications. o Evidence that out-year pilot study selection will provide scientifically rigorous and potentially fundable projects. o Evidence of the ability to disseminate through professional and less formal mechanisms, information learned about recruiting and retaining minority population members in research on health and access of older minority populations. o Evidence that the mentoring strategy is likely to produce and retain minority professionals in aging research. The Measurement Core will be evaluated based upon the following criterion. o Evidence of prior experience in the creation and/or use of culturally sensitive and specific measurement tools. Should the RCMAR choose to apply for the Coordinating Center, it should meet the following criteria. o Evidence of experience with, or a reasonable expectation of success in, providing diverse sites with logistic support in arranging for annual meetings and in preparing pre- and post-meeting materials. o Evidence that the CC will be able to foster interaction between all sites for sharing developments and findings such as mentoring progress, new research tools, recruitment and retention strategies that work/do not work, etc. o Evidence that the CC can draft an annual progress report, serve the clearinghouse function, and create a summary report near the conclusion of the first four years of RCMAR experience. AWARD CRITERIA The anticipated date of award will be September 1997. Funding criteria will be scientific merit (based on the Review Criteria), availability of funds, and program priorities. Among those priorities is representation from African American, Hispanic, Asian, and Native American Indian populations among the selected RCMARs. Therefore, final selection will take into account racial and ethnic variation both within and between proposals to select a balance among the most qualified of the RCMAR proposals. INQUIRIES Inquiries are encouraged. The opportunity to clarify issues or answer questions from potential applicants is welcome. Inquiries regarding programmatic issues and the application process, as well as letters of intent, may be directed to: Sidney M. Stahl, Ph.D. Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue, Suite 533 Bethesda, MD 20892-9205 Telephone: (301) 402-4156 FAX: (301) 402-0051 Email: Sidney_Stahl@nih.gov J. Taylor Harden, Ph.D. Extramural Programs National Institute of Nursing Research 45 Center Drive, Room 3AN-12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6906 FAX: (301) 480-8260 Email: THarden@ep.ninr.nih.gov Direct inquires regarding fiscal matters to: David Reiter Grants Management Office National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: DR36T@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.866, 93.361. 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. References Ferraro, Kenneth F. and Melissa M. Farmer. 1996. Double Jeopardy to Health Hypothesis for African Americans: Analysis and Critique." Journal of Health and Social Behavior 37:27-43. Harris, Yvonne, Philip Gorelick, Patricia Samuels and Isaac Bempong. (forthcoming). "Why African Americans May Not be Participating in Clinical Trials." Journal of the National Medical Association 88. Link, Bruce G. And Jo Phelan. 1995. "Social Conditions as Fundamental Causes of Disease." Journal of Health and Social Behavior (Extra Issue):80-94. Marquis, M. Susan and Stephen H. Long. 1996. "Reconsidering the Effect of Medicaid on Health care Services Use." Health Services Research 30:791-808. Prohaska, T. and J. Walcott-McQuigg. (forthcoming). "Recruitment of Older African Americans. A Focus Group Approach. Journal of Aging and Ethnicity. Weissman, Joel S. And Arnold M. Epstein. 1994. Falling through the Safety Net. Baltimore: The Johns Hopkins University Press. From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 28 December 1996 Date: 15 Jan 1997 16:06:48 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 84 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bjreo$ojb@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending December 28, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: INT 96-48 NSF/Europe Report No. 81 June 1996 European Commission - The Joint Research Centre File size (bytes): 12193 STIS Filename: int9648.txt Also available: int9648.doc Title: INT 96-49 NSF/Europe Report No. 80 March 1996 A View of Italian Science File size (bytes): 14215 STIS Filename: int9649.txt Also available: int9649.doc Document Type: Letter Title: NSF 97-35 Dear Colleague, Conservation and Restoration Biology File size (bytes): STIS Filename: nsf9735.txt (NSF) Document Type: Program Guideline Title: NSF 97-38--Coastal Ocean Processes (CoOP) Coastal Studies in the Great Lake File size (bytes): 20710 STIS Filename: nsf9738.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: International Document Title: INT 96-47 NSF/EUROPE Report No. 79 ONR-EUROPE Computer and Software Technology Newsletter No.15 INRIA - THE FRENCH NATIONAL INSTITUTE FOR RESEARCH IN COMPUTER SCIENCE AND CONTROL File size (bytes): 12362 STIS Filename: int9647.txt Also available: int9647.doc ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vex973.txt, the text of your message should be as follows: get vex973.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vex973.txt, you would enter: ftp> get vex973.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 4 January 1997 Date: 15 Jan 1997 16:05:51 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 77 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bjrcv$ohb@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending January 4, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: Bulletin Title: January Bulletin Vol 24; No. 5 File size (bytes): 54738 STIS Filename: bul9701.txt Document Type: International Document Title: INT 96-50 NSF/Europe Report No. 84, July 1996 Science in Latvia File size (bytes): 26653 STIS Filename: int9650.txt Also available: int9650.doc Document Type: Press Release Title: FALSE IDENTIFICATION NEW RESEARCH SEEKS TO INOCULATE... File size (bytes): STIS Filename: pr971.txt Document Type: Recruit Title: Geographer (Program Director) File size (bytes): 7568 STIS Filename: vex975.txt Title: Office Automation Clerk File size (bytes): 8984 STIS Filename: vgs9721.txt Title: Program Assistant (OA) File size (bytes): 9215 STIS Filename: vgs9722.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vex973.txt, the text of your message should be as follows: get vex973.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vex973.txt, you would enter: ftp> get vex973.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 21 December 1996 Date: 15 Jan 1997 16:04:51 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 112 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bjrb3$o6d@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending December 21, 1996. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: International Document-NSF/Europe Rpt No 82 June 1996 File size (bytes): 18818 STIS Filename: int9642.txt Title: INT96-43-NSF Europe Report No 83 June 1996 File size (bytes): 28330 STIS Filename: int9643.txt Title: INT96-46 NSF/Europe Report No 86 August File size (bytes): 22683 STIS Filename: int9646.txt Title: INT 96-47 NSF/EUROPE Report No. 79 ONR-EUROPE Computer and Software Technology Newsletter No.15 INRIA - THE FRENCH NATIONAL INSTITUTE FOR RESEARCH IN COMPUTER SCIENCE AND CONTROL File size (bytes): 12358 STIS Filename: int9647.txt Also available: int9647.doc Document Type: Letter Title: nsf9734.txt - Dear Colleague Letter - Mars-Rock Special Research Opportunity (NSF 97-34) File size (bytes): STIS Filename: nsf9734.txt Document Type: Program Guideline Title: NSF 97-23 - Mathematical Sciences Research Institutions File size (bytes): 19953 STIS Filename: nsf9723.txt Title: NSF 97-27 - New Technologies Program File size (bytes): 9902 STIS Filename: nsf9727.txt Title: NSF 97-28 - Societal Dimensions of Engineering, Science, and Technology Ethics and Values Studies Research on Science and Technology File size (bytes): STIS Filename: nsf9728.txt Also available: nsf9728.pdf Title: NSF 97-39--NSF/DOE Partnership in Basic Plasma Science and Engineering File size (bytes): 11738 STIS Filename: nsf9739.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Letter Title: REULIST -- Current List of REU Sites File size (bytes): 89367 STIS Filename: reulist.txt Document Type: Recruit Title: Program Director File size (bytes): 7106 STIS Filename: vex973.txt Title: Program Director File size (bytes): 7106 STIS Filename: vex973.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vex973.txt, the text of your message should be as follows: get vex973.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vex973.txt, you would enter: ftp> get vex973.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PAR-97-023 - V26(01) 01/10/97 Date: 16 Jan 1997 14:08:14 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 311 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bm8se$g83@net.bio.net> NNTP-Posting-Host: net.bio.net INTERNET CONNECTION FOR MEDICAL INSTITUTIONS NIH GUIDE, Volume 26, Number 1, January 10, 1997 PA NUMBER: PAR-97-023 P.T. 15, 18; K.W. 1004017 National Library of Medicine PURPOSE The National Library of Medicine (NLM) is encouraging the development of a communications infrastructure to promote the rapid interchange of medical information nationally and throughout the world. This infrastructure is based upon the Internet, a network of networks, that is a key element in important Federal initiatives in High Performance Computing and Communication (HPCC) and the National Information Infrastructure (NII). Internet access provides health professionals engaged in education, research, clinical care, and administration with a means of accessing remote databases, libraries, NLM's Internet Grateful Med, DOCLINE, and Loansome Doc, of transferring files and images, and of interacting with colleagues throughout the world. To accelerate the pace with which health-related institutions become part of the electronic information web, NLM is offering grants to support institution-wide Internet connections. 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), Internet Connection for Medical Institutions, is related to the priority area of surveillance and data systems. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No: 017 001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Domestic, public and private, non-profit institutions engaged in health sciences administration, education, research, and/or clinical care are eligible to apply. "Health sciences" is defined as medicine, dentistry, nursing, public health, pharmacy, veterinary medicine, and other sciences related to health. Hospitals are encouraged to apply. Racial/ethnic minority individuals, women, and those with disabilities are encouraged to apply as Principal Investigators. Domestic applications may not have international components. Groups (or cooperatives) of health-related institutions are also eligible to apply. A single, lead institution must apply on behalf of the group. MECHANISM OF SUPPORT This PA uses the National Library of Medicine (NLM) Resource Grant (G08) mechanism. Indirect costs are not provided. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed one year. For a single institution, support is available up to $30,000; a group of institutions may receive up to $50,000 to support development of a multi-institution network including extending extant connectivity to outlying sites, or otherwise furthering NLM's goal of expanding information outreach. The overall cost of a connection to the Internet includes: gateway or router equipment, associated communication hardware (CSU/DSU), the leased line and its installation, local area network user support staff, and Internet Service Provider fees. The NLM grant is expected to support the purchase and installation of the gateway system and associated connection hardware, the cost of installation and leasing of communication circuits to connect to the Internet Service Provider, and the cost of Internet Service Provider fees. Institutions are expected to fund personnel, personal computers, and local area network costs. The emphasis of the Internet project should be towards initiating institution-wide Internet access; therefore, costs for website development are discouraged. Grant funds may be used to extend Internet access to other sites from an institution with an existing connection. RESEARCH OBJECTIVES Background The Internet currently is a collection of interconnected networks and comprises three types of networks: (1) a national backbone network, (2) regional networks (Internet Service Providers) usually based around some geographical region of the country, and (3) local networks at educational, research and clinical institutions. Individual institutions are connected to a regional network in the appropriate geographical area. The regional network is in turn attached to the high-speed national backbone network, usually at its network operation center. The backbone is connected to other national networks including the Defense Research Internet, NASA Science Network, and the Energy Sciences Network; these interconnected networks and many others worldwide comprise the Internet. The Internet provides electronic mail service and access to a variety of scientific resources including: digital libraries, unique databases such as MEDLINE via Grateful Med as well as a host of federal and private sector databases, supercomputers, and remote scientific sensing instruments. The Internet promotes interaction and collaboration with a single, well-integrated connection to end users using the Defense Data Network protocols: Transmission Control Protocol/Internet Protocol referred to as TCP/IP. Network management and operations services as well as information services are provided by each of the levels. The national backbone network provides for technical and information services to the Internet Service Providers which may provide technical expertise and information services, including training and documentation, to local network administrators. Local network officials provide technical and information services to the overall local network administration and may also provide consultative and liaison services to end-users of the network. Scope The purpose of this PA is to encourage U.S. medical institutions including medical research institutions, health science schools, hospitals, and professional organizations to connect to the Internet. Some institutions may belong to organizations that are already connected to the Internet, for example, medical schools adjacent to university campuses. In such a case, the NLM grant can be used by a health science school or hospital to link to an existing Internet connection. In other cases, the project will aid the institution in initiating a direct connection to the Internet Service Provider. In general, it is expected that institutions will use an existing local area network to distribute wide access to the Internet, or will build a new local area network and connect it to the Internet. A local area network is connected to the Internet by installing an IP router/gateway. This gateway will link the local area network to an appropriate Internet Service Provider by means of leased or dial-up communication circuits of varying speeds (9600 bits per second to 1.5 million bits per second). The resultant connections to the Internet provided by the gateway should be made widely available to all appropriate health professionals -- researchers, faculty, students, clinicians, and administrators. Ideally the institution will have installed a high-speed local area network and have adopted the TCP/IP protocols as the standard communication protocol. Where other networking protocols are used, the institution will be responsible for the installation of any additional network gateway systems required to resolve the protocol conversion issues so as to provide connectivity to the Internet gateway. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the standard deadline dates (February 1, June 1 and October 1) as indicated in the instructions. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: asknih@odrockm1.od.nih.gov; and from the program administrator listed under INQUIRIES. Supplemental Application Guidelines Applicants should not feel constrained by the emphasis on research in the language used by the forms. It may be useful for an applicant to read "project" whenever the form and instructions refer to "research". NLM considers these grants to be projects, not research applications, and will evaluate the applications in that spirit. NLM recommends that those writing the application keep the "project" concept in mind. Internet uses may support administration, education, research and/or patient care endeavors. Applicants are encouraged to include their health science library in the proposed Internet connection. "Biographical Sketch" form page (FF). Include computer, communications, networking skills, including TCP/IP experience, and Internet training. "Resources" form page (HH). Applicants are encouraged to substitute applicable headings such as computers, communications, and networking resources. For multiple institutions these must be described for each site. Letters of agreement or memoranda of understanding defining mutual responsibilities must be provided in the application and signed by authorized officials of each participating institution. In Section 9 of the "Research Plan" (read "Project Plan") also provide: 1) proposed benefits of Internet access to the targeted population; 2) plans for provision of institution-wide access, user training and user support and 3) plans for future support. The success of an Internet connection depends upon training users in establishing accounts and passwords and in teaching Internet capabilities. Describe user training plans including topics to be covered and the personnel who will provide the training and follow-up, ongoing training. Library involvement in user training is strongly encouraged. In regard to future support, the Internet Connection Grant is intended to provide seed money to initiate an Internet connection; therefore, plans for budgeting ongoing costs for Internet access must be described. All applicants, particularly those relatively unfamiliar with the application review form and with NIH procedures, are encouraged to consult Ms. Frances Johnson (address below) for assistance as needed in completing the application. Additional Application Procedures Each application must be identified by checking "YES" on Line 2 of the face page, and the number and title of this program announcement must be typed in Section 2. Submit a signed, typewritten original of the application, including the Checklist, and five legible, single-sided copies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, MSC 7710, SUITE 1040 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG) and responsiveness by NLM. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the PA will be evaluated for merit by an appropriate peer review group convened by the NLM in accordance with the review criteria stated below. Applications that are complete and 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 Significance of proposed project relative to the services, programs and personnel expected to benefit from Internet access, and the nature of the anticipated benefits. o Quality of local infrastructure including plans to provide broad institutional access to the Internet gateway and plans to develop institution-wide high-speed networks. o Quality of user services and proposed training. o Technical expertise in computer networking (especially TCP/IP based networking) or plans to provide such expertise including coordination with appropriate Internet service provider. o Plans for future support of the network connection. AWARD CRITERIA In addition to the review criteria identified above, awards depend upon available funds and programmatic priorities. INQUIRIES Written, electronic, and telephone inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ms. Frances E. Johnson Division of Extramural Programs National Library of Medicine Building 38A, Room 5S-506 Bethesda, MD 20894 Telephone: (301) 496-4621 FAX: (301) 402-0421 Email: FJOHNSON@NLM.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Ruth Bortz Grants Management Specialist Division of Extramural Programs National Library of Medicine Telephone: (301) 496-4253 FAX: (301) 402-0421 Email: BORTZ@NES.NLM.NIH.GOV AUTHORITY AND REGULATIONS The Resource Grant Program is described in the "Catalog of Federal Domestic Assistance" under Medical Library Assistance, Chapter 93.879. Grants will be awarded under the authority of the Public Health Service Act, Section 474(42 USC 286b-5) and administered under PHS grant policies and Federal Regulations, most specifically at 42 CFR Part 59a and 45 CFR Part 74. This program is not subject to the inter-governmental 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. From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-022 - V26(01) 01/10/97 Date: 16 Jan 1997 14:07:56 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 351 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bm8rs$g4e@net.bio.net> NNTP-Posting-Host: net.bio.net CELLULAR AND MOLECULAR MECHANISMS OF PRIMARY PULMONARY HYPERTENSION NIH GUIDE, Volume 26, Number 1, January 10, 1997 PA NUMBER: PA-97-022 P.T. 34; K.W. 1002004, 1002008, 0715115, 0705048 National Heart, Lung, and Blood Institute Office of Research on Women's Health Office of Rare Disease Research PURPOSE The National Heart, Lung, and Blood Institute (NHLBI), the Office of Research on Women's Health, and the Office of Rare Disease Research invite qualified researchers to submit applications for research project grants to investigate the cellular and molecular mechanisms of the etiology and pathogenesis of primary pulmonary hypertension (PPH). The purpose of this program announcement is to stimulate basic research using cellular and molecular approaches to studying the development and subsequent progression of PPH. Applicants are required to study patients diagnosed with PPH or to use materials of patient origin. 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, Cellular and Molecular Mechanisms of Primary Pulmonary Hypertension, 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 Summary Report: Stock No. 017-001-004730-01) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). ELIGIBILITY REQUIREMENTS Applications for research grants may be submitted by foreign and domestic, public and private, for-profit and non-profit organizations, such as universities, colleges, hospital, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) (R29) awards. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply. MECHANISM OF SUPPORT The primary mechanisms for support of this program announcement are the research project grant (R01) and the FIRST award (R29). Because the nature and scope of the research proposed in response to this PA may vary, it is anticipated that the size of awards will vary also. Primary pulmonary hypertension (PPH) is a rare disease of unknown cause characterized by abnormally high pressure in the pulmonary artery. The first case of unexplained pulmonary hypertension was described in the literature by Romberg in 1891. In 1951 Dresdale and associates described a series of 39 patients with unexplained pulmonary hypertension and coined the term primary pulmonary hypertension to describe this condition. The diagnostic criteria currently used, as developed by the NHLBI national patient registry, is a mean pulmonary artery pressure of 25 mm Hg at rest or 30 mm Hg during exercise in the absence of other chronic lung or heart disease. The incidence of PPH is unknown, but estimates range from 1 to 2 per million in the general population. PPH can occur in individuals of all ages and both genders, but it appears to affect predominately women in their third and fourth decades of life. The diagnosis of PPH is difficult as there are no specific signs or symptoms in the early stages of the disease. The time from early symptoms to diagnosis is often 2 to 3 years or longer. The most common presenting symptom is dyspnea; other common symptoms are fatigue, chest pain and near syncope. The pathogenesis of PPH is not clearly understood. It is also not known whether PPH is a single disease or a variety of diseases with the same common end stage lung condition. The increased vascular resistance seen in PPH has been attributed to two major factors: 1) vasoconstriction and 2) thickening or remodeling of the vascular arterial wall. There is also a tendency for blood clots to form within the small vessels. Many questions remain unanswered about the etiology and pathogenesis of primary pulmonary hypertension. It has been suggested that abnormalities in pulmonary vascular endothelial function may play a major role in initiating the process that ultimately leads to PPH. Studies in PPH patients have shown an imbalance in the ratio of the metabolites of prostacyclin and thromboxane. Other studies have shown an impaired synthesis of the endothelial-derived vasodilator nitric oxide, that could be due to a reduced level or activity of nitric oxide synthetase. Endothelin, a potent endothelial-derived vasoconstrictor, has been found to be at abnormally high levels in PPH patients. Other mediators that have been suggested to have a role in PPH are serotonin and angiotensin. More studies are needed to determine whether the abnormal levels of these mediators are the cause or result of the hypertensive arteriopathy seen in PPH patients. A number of cytokines and growth factors, including interleukin-1 and interleukin-6, transforming growth factor, and vascular endothelial growth factor have all been implicated in the thickened arterial vascular wall seen in PPH. The role of inflammatory cytokines and growth factors in the development and progression of PPH needs to be better defined. Also, the enhanced thrombotic state, that may be related to endothelial dysfunction or platelet abnormalities, needs further study. Another area of interest is that of calcium and potassium transport in vascular smooth muscle cells. Immune dysfunction has also been postulated to play a role in PPH. There is evidence to suggest that susceptibility to PPH may be influenced by products of the major histocompatibility complex. There is no cure for PPH and treatment is limited. The mean survival time of the registry patients was 2.8 years, but this has been extended in some patients using newer treatment modalities. The most widely used vasodilators are the calcium channel blockers, nifedipine and diltiazem, which produce sustained improvement in 25 to 30 percent of patients. Recently, epoprostenol (prostacyclin) became available for patients who do not respond to oral vasodilators but, unfortunately, the drug has to be delivered by continuous intravenous infusion. In a randomized clinical trial, it has recently been shown that epoprostenol improved hemodynamics, exercise tolerance, quality of life and survival in patients with New York Heart classification III and IV. More recently a few patients are apparently having beneficial effects from chronic inhalation of nitric oxide. The only other therapy available is lung transplantation, but that also has many disadvantages, including shortage of donor organs and acute and chronic rejection and infection. Several factors have been associated with the development of pulmonary hypertension, that has clinical and pathologic features similar to that of primary pulmonary hypertension. These factors include portal hypertension, Raynaud's disease, infection with human immunodeficiency virus, and the use of diet suppressants, including aminorex and fenfluramine. Since only a small percentage, 0.5 to 2 percent, of the individuals exposed to these factors actually develop pulmonary hypertension, it has been suggested that a predisposition, perhaps genetically determined, must be present for PPH to develop in response to a stimulus. Approximately 6 to 10 percent of PPH cases are familial, which clearly involves a genetic basis. The purpose of this program announcement is to stimulate basic studies of the cellular and molecular mechanisms involved in the development and pathogenesis of primary pulmonary hypertension. Knowledge from these types of basic studies should be helpful in designing more effective treatment for PPH. The research topics identified above are examples of studies that would meet the goals of this program announcement. It is not required that all or any of these topics be included; investigators are encouraged to consider other topics that are relevant this program. SPECIAL REQUIREMENTS To be responsive to this program announcement the studies must be conducted in patients diagnosed with PPH or on materials obtained >From PPH patients. This could include blood samples, lung tissue >From patients receiving transplants or biopsy/autopsy specimens. Although studies of other forms of pulmonary hypertension can be included for comparison purposes, the major focus of the application must be on PPH. Studies in animal models of pulmonary hypertension will not be considered responsive to this announcement. Applications that propose descriptive morphologic studies and do not contain any hypothesis driven mechanistic studies will not be acceptable. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results >From the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators also may obtain copies of the policy form from the program staff listed under INQUIRIES. Program Staff may also provide additional relevant information concerning the policy. (NOTE: When the proposed study involves a gender specific study or a single or limited number of minority population groups, this should also be stated to inform reviewers.) APPLICATION PROCEDURES Researchers who are considering preparing an application in response to this program announcement are invited, but not required, to discuss their project and possible grant mechanisms with NHLBI staff listed under INQUIRIES in advance of formal submission. This may be done by telephone, mail, or E-mail. The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants and will be accepted at the standard application deadlines as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov; and from the program administrator listed under INQUIRIES. The PA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. FIRST (R29) award applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST award applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. The original and five copies must be mailed to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040-MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit in accordance with the standard NIH peer review procedures. Applications that are complete 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; o the initial review group will also examine the proposed study for the protection of human subjects and the safety of the research environment. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review; availability of funds; and program priority. 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: Dorothy B. Gail, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10018, MSC-7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: Gaild@gwgate.nhlbi.nih.gov Carrie P. Hunter, M.D., M.P.H. Office of Research on Women's Health National Institutes of Health Building 1, Room 201, MSC-0161 Bethesda, MD 20892-0161 Telephone: (301) 402-1770 FAX: (301) 402-1798 Email: Hunterc@od1tm1.od.nih.gov Stephen Groft, Pharm.D. Office of Rare Disease Research National Institutes of Health 7550 Wisconsin Avenue, Room 618 Bethesda, MD 20892 Telephone: (301) 402-4336 FAX: (301) 402-0420 Email: Grofts@nih.gov Direct inquiries regarding fiscal matters to: Ray Zimmerman Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7154, MSC-7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: Zimmermr@gwgate.nhlbi.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. 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 174. 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. From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 01, pt. 2of2, 10 January 1997 Date: 16 Jan 1997 14:06:38 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 104 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bm8pe$ft0@net.bio.net> NNTP-Posting-Host: net.bio.net procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Ms. Frances E. Johnson Division of Extramural Programs National Library of Medicine Building 38A, Room 5S-506 Bethesda, MD 20894 Telephone: (301) 496-4621 Email: FJOHNSON@NLM.NIH.GOV $$P2 END ************************************************************ $$P3 BEGIN PA-97-024 FULL-TEXT ************************************** SPINAL CORD INJURY: EMERGING CONCEPTS NIH GUIDE, Volume 26, Number 1, January 10, 1997 PA AVAILABLE: PA-97-024 P.T. 34; K.W. 0705055, 0715027, 0765040 National Institute of Neurological Disorders and Stroke National Eye Institute National Institute of Child Health and Human Development National Institute of Nursing Research Application Receipt Dates: February 1, June 1, October 1 PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS), National Eye Institute (NEI), National Institute of Child Health and Human Development (NICHD), and National Institute of Nursing Research (NINR) invite research project grant (R01) and First Independent Research Support and Transition (FIRST) (R29) award applications for support of research that will increase our knowledge of the mechanisms that underlie processes of injury and repair in the central nervous system, including optic nerve and other CNS tracts, and that will provide strategies for therapeutic intervention in spinal cord injury. 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 PA, Spinal Cord Injury: Emerging Concepts, is related to the priority area of unintentional injuries. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH Gopher (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail, and email from the program contacts listed below. Dr. Mary Ellen Cheung Division of Stroke, Trauma, and Neurological Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 8A-13 Bethesda, MD 20892 Telephone: (301) 496-4226 FAX: (301) 480-1080 Email: mm108w@nih.gov Dr. Michael D. Oberdorfer Strabismus, Amblyopia, and Visual Process Branch National Eye Institute 6120 Executive Boulevard, Suite 350, MSC 7164 Bethesda, MD 20892-7164 Telephone: (301) 496-5301 FAX: (301) 496-0528 Email: mo5r@nih.gov Dr. Danuta Krotoski National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 6100, Room 2A03, MSC 7510 Bethesda, MD 20892 Telephone: (301) 402-2242 FAX: (301) 402-0832 Email: dk58p@nih.gov Dr. Mary D. Leveck Scientific Program Administrator National Institute of Nursing Research Building 45, Room 3AN-12, MSC 6300 Bethesda, MD 20892 Telephone: (301) 594-5963 FAX: (301) 480-8260 Email: mleveck@ep.ninr.nih.gov $$P3 END ************************************************************ From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 01, pt. 1of2, 10 January 1997 Date: 16 Jan 1997 14:06:26 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1494 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bm8p2$fs7@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 1 - January 10, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** TROPICAL MEDICINE AND PARASITOLOGY - NIH EXTRAMURAL REINVENTION PILOT STUDIES Office of Extramural Research Division of Research Grants Tropical Medicine and Parasitology Study Section National Institute of Allergy and Infectious Diseases INDEX: EXTRAMURAL RESEARCH; RESEARCH GRANTS; TROPICAL MEDICINE, PARASITOLOGY; ALLERGY, INFECTIOUS DISEASES $$INDEX N2 ********************************************************** SELF-ONLY HEALTH INSURANCE AND TUITION COSTS ON NIH NRSA POSTDOCTORAL FELLOWSHIP AWARDS -- MODIFIED POLICY National Institutes of Health INDEX: NATIONAL INSTITUTES OF HEALTH $$INDEX N3 ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS National Institutes of Health Food and Drug Administration INDEX: NATIONAL INSTITUTES OF HEALTH; FOOD AND DRUG ADMINISTRATION $$INDEX N4 ********************************************************** NCI COOPERATIVE HUMAN TISSUE NETWORK National Cancer Institute INDEX: CANCER $$INDEX N5 ********************************************************** AVAILABILITY OF BIOLOGIC SAMPLES FROM DIABETIC STUDY POPULATION National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX N6 ********************************************************** NINDS REVISED PROGRAM PROJECT GUIDELINES National Institute of Neurological Disorders and Stroke INDEX: NEUROLOGICAL DISORDERS, STROKE NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 04/18/97 ************************************************* RESOURCE CENTERS FOR MINORITY AGING RESEARCH (RFA AG-97-002) National Institute on Aging National Institute of Nursing Research INDEX: AGING; NURSING RESEARCH $$INDEX R2 04/24/97 ************************************************* COMBINED BEHAVIORAL/PHARMACOLOGIC TREATMENT OF ALCOHOLISM (RFA AA-97-004) National Institute on Alcohol Abuse and Alcoholism INDEX: ALCOHOL ABUSE, ALCOHOLISM $$INDEX R3 04/25/97 ************************************************* EDUCATIONAL WORKSHOPS IN INTERDISCIPLINARY RESEARCH (RFA OD-97-004) Office of Behavioral and Social Sciences Research National Center for Research Resources National Institute of Nursing Research National Institute on Drug Abuse National Institute of Dental Research INDEX: BEHAVIORAL, SOCIAL SCIENCES; RESEARCH RESOURCES; NURSING; DRUG ABUSE; DENTAL $$INDEX R4 04/29/97 ************************************************* IMPROVED TECHNOLOGIES FOR PRODUCTION OF FULL-LENGTH HUMAN cDNA (RFA CA-97-012) National Cancer Institute INDEX: CANCER $$INDEX R5 04/30/97 ************************************************* HOST FACTORS CONTROLLING INDIVIDUAL SUSCEPTIBILITY TO HIV-ASSOCIATED PULMONARY DISEASE (RFA HL-97-001) National Heart, Lung, and Blood Institute INDEX: HEART, LUNG, BLOOD $$INDEX P1 ********************************************************** CELLULAR AND MOLECULAR MECHANISMS OF PRIMARY PULMONARY HYPERTENSION (PA-97-022) National Heart, Lung, and Blood Institute Office of Research on Women's Health Office of Rare Disease Research INDEX: HEART, LUNG, BLOOD; WOMEN'S HEALTH; RARE DISEASES $$INDEX P2 ********************************************************** INTERNET CONNECTION FOR MEDICAL INSTITUTIONS (PAR-97-023) National Library of Medicine INDEX: NATIONAL LIBRARY OF MEDICINE $$INDEX P3 ********************************************************** SPINAL CORD INJURY: EMERGING CONCEPTS (PA-97-024) National Institute of Neurological Disorders and Stroke National Eye Institute National Institute of Child Health and Human Development National Institute of Nursing Research INDEX: NEUROLOGICAL DISORDERS, STROKE; EYE; CHILD HEALTH, HUMAN DEVELOPMENT; NURSING The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the nih gopher (gopher.nih.gov) and the NIH web site (http://www.nih.gov). Alternative access is available through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing (new, renewal, amended (revised) applications for grants, cooperative agreements, and fellowships from the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact to which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAS, AND RFAS IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. 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. ORGANIZATIONS DESCRIBED IN SECTION 501(c)4 OF THE INTERNAL REVENUE CODE OF 1968 THAT ENGAGE IN LOBBYING ARE NOT ELIGIBLE TO RECEIVE GRANT/COOPERATIVE AGREEMENT AWARDS. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN NOT-97-001 FULL-TEXT ************************************* TROPICAL MEDICINE AND PARASITOLOGY - NIH EXTRAMURAL REINVENTION PILOT STUDIES NIH GUIDE, Volume 26, Number 1, January 10, 1997 P.T. 34; K.W. 1014006 Office of Extramural Research Division of Research Grants Tropical Medicine and Parasitology Study Section National Institute of Allergy and Infectious Diseases BACKGROUND The information in this notice is primarily directed to applicants, peer reviewers, awardees, and NIH staff in Tropical Medicine and Parasitology (TMP). The National Institutes of Health (NIH) has been designated an Extramural Programs Reinvention Laboratory. A series of experiments have been and are being undertaken in a partnership between the Office of Extramural Research (OER), Division of Research Grants (DRG), and National Institute of Allergy and Infectious Diseases (NIAID) to test ways to simplify and expedite the grant application submission, review, and award processes. This notice describes a series of interrelated pilot studies to (1) test methods for shortening the interval from application submission to grant award and (2) assess methods for reducing the amount of information provided by applicants. THE FIVE INTER-RELATED STUDIES The major objectives of these studies are to: (1) determine if the first and second levels of peer review of grant applications can be completed in a shorter interval of time (as little as four to five months compared with the current eight to eleven months) without loss of quality; (2) determine if less information can be obtained from applicants without impeding the review of applications and award of grants; and (3) assess changes in patterns and levels of effort of NIH staff, peer reviewers, and applicants that would be needed to make these types of changes across the NIH. In addition to the study specific evaluations outlined above, focus groups of applicants, peer reviewers, and NIH staff will be convened to assess this group of interrelated studies. ISSUES 1. NIH ASSIGNMENT OF ALL GRANT APPLICATIONS REQUIRES ABOUT SIX WEEKS. NIH receives about 40,000 grant applications annually. Under the current procedure, a DRG referral officer reviews each application and assigns it both to a study section for review and to one or more NIH Institutes or Centers for potential funding. For standard receipt dates, it takes up to six weeks for the referral officers to complete review and assignment of all applications. Elimination or reduction of this time period would reduce the time interval between receipt of applications and their peer review. 2. PEER REVIEW GROUP ADDRESSES ALL APPLICATIONS AND ISSUES DURING THE MEETING - THIS DELAYS SUMMARY STATEMENT PREPARATION AND LENGTHENS STUDY SECTION MEETINGS. Study section members receive applications for review at least a month before the study section meets. Although designated reviewers complete their reviews and written comments before the meeting, this information is not available to other study section members until the dates of the meeting. Making written comments of reviewers available to all study section members before the meeting could (1) enable a portion of the process to be completed earlier, (2) reduce the duration of study section meetings, (3) focus the meetings on important issues regarding each application, and (4) expedite the preparation and release of summary statements. 3. HUMAN SUBJECTS ASSURANCES AND CERTIFICATIONS ARE REQUIRED TO BE SUBMITTED WITH THE GRANT APPLICATION OR WITHIN 60 DAYS OF ITS SUBMISSION AND PRIOR TO PEER REVIEW). Twenty to 25 percent of research grant applications reviewed by a study section are funded. The time and effort required for applicant institutions to complete Institutional Review Board (IRB) activities for the 70 to 75 percent of applications unfunded may be unnecessary and inefficient. 4. WHEN REVISED APPLICATIONS ARE NECESSARY, ENTIRE APPLICATIONS ARE RESUBMITTED - THIS REQUIRES SUBSTANTIAL APPLICANT TIME AND EFFORT AND DELAYS THE RE-REVIEW OF REVISED (AMENDED) APPLICATIONS. The current process for revision, resubmission, and re-review of grant applications requires all applicants to resubmit entire applications. Generally, this means that revised applications are re-submitted and re-reviewed two review cycles (eight months) later. Applicants who need to address or clarify only minor points are treated the same as applicants who must address significant concerns with extensive revisions of their applications. This delays reconsideration of highly meritorious applications and impedes their potential funding. 5. ADVISORY COUNCILS AND BOARDS PERFORM THEIR SECOND LEVEL OF REVIEW OF GRANT APPLICATIONS AT COUNCIL MEETINGS - THE SUMMARY STATEMENTS FOR MANY SCIENTIFICALLY MERITORIOUS APPLICATIONS ARE AVAILABLE TWO TO THREE MONTHS BEFORE THESE COUNCILS/BOARDS MEET. As a result, applicants must wait to hear whether their applications are to be funded until after the Council meeting. A process for early Council review would enable earlier award of grants. THE PILOT STUDIES Each pilot study is outlined in the following paragraphs. For each, quantitative evaluation measures are identified. In addition to these, an overall evaluation using focus group(s) of applicants, peer reviewers, and NIH staff will be established. The members will be asked to assess effects of these studies on the application, peer review process, and award process and to recommend future directions. STUDY 1: SELF-ASSIGNMENT OF APPLICATIONS TO A STUDY SECTION AND A FUNDING INSTITUTE. Virtually all applications reviewed by the TMP Study Section have historically been assigned to the NIAID for potential funding. The TMP study section reviews applications that propose experimental, epidemiological/field, and clinical studies of parasites and parasitic diseases. Studies of the cellular/molecular biology, biochemistry, genetics, epidemiology, and immunology of these parasites are reviewed as are projects relevant to the diagnosis, pathogenesis, prevention and therapy of parasitic infections. (NOTE: Studies of the vectors of parasitic diseases are reviewed separately by a Special Emphasis Panel and will not be considered as part of this pilot.) During the pilot test, applicants proposing studies in these areas will be able to submit their applications on SPECIAL later receipt dates. It is important that applicants use these special receipt dates; the applications received on these special receipt dates will receive expedited handling by DRG. This will reduce the interval between application receipt and peer review. The following are the SPECIAL delayed receipt dates for all applications (new, competing renewal, revised, and supplements): USE THE SPECIAL INSTEAD FOR RECEIPT DATE OF REGULAR RECEIPT DATES OF March 7, 1997 February 2, 1997 and March 1, 1997 July 8, 1997 June 1, 1997 and July 1, 1997 November 7, 1997 October 1, 1997 and November 1, 1997 Applicants should enter "TMP Pilot" and Institute (almost always "NIAID") after Title: in item 2 of the PHS 398 face page. The original, four copies, and all set of appendices must be sent or delivered to: DR. SUZANNE FISHER REFERRAL SECTION DIVISION OF RESEARCH GRANTS 6701 ROCKLEDGE DRIVE, ROOM 2030 - MSC 7720 BETHESDA, MD 20892-7720 BETHESDA, MD 20817 (for express/courier service) One copy of the application must be sent at the same time to: DR. GERALD LIDDEL REFERRAL OFFICE DIVISION OF RESEARCH GRANTS 6701 ROCKLEDGE DRIVE, ROOM 4186 - MSC 7808 BETHESDA, MD 20892-7808 BETHESDA, MD 20817 (for express/courier service) EVALUATION. Evaluation of Pilot Study results: (1) The number and percent of applicants who submitted on the special receipt dates; and (2) the number and percentage correctly self-assigned to the TMP Study Section and potential funding Institutes. STUDY 2: ELECTRONICALLY-ASSISTED PEER REVIEW The NIAID has developed a World Wide Web-based electronic review system and is testing the system in NIAID-conducted peer reviews. The system allows study section members to submit their electronically-encrypted reviews to a password-secured Web server prior to the Study Section meeting. When all reviews have been submitted, only assigned reviewers, other study section members, and DRG staff can access and consider these reviews. Special measures are taken to eliminate conflict-of-interest by prohibiting members >From access to reviews of applications with which they are in conflict. The essential components of the peer review system remain unchanged, and as under current procedures, independent scoring of applications is done by each review at the meeting. The TMP study section will test this system for review of applications received on the special receipt dates of March 7, July 8, and November 7, 1997 for final consideration at the June 19-20 and October 1997 and February 1998 study section meetings. EVALUATION. Evaluation of Pilot Study results: (1) percent of reviewers using the WWW system; (2) percent of critiques finalized via WWW; (3) percent of reviewers adhering to schedules for uploading/responding; (4) time savings at peer review meeting; (5) changes in DRG review workload; and (6) changes in completion schedules for summary statements. STUDY 3: IRB DATA FOR ONLY FUNDABLE APPLICATIONS. Applicants who self-assign for peer review to the TMP study section and for consideration for funding to the NIAID will have the opportunity to defer assurances and certifications for human subjects. NIAID will request this information only from fundable applicants immediately after peer review; NIAID already has a process in place to request needed additional pre-award information. Applicants submitting for the March 7, July 8, and November 7, 1997 receipt dates have the option of deferring submission of the human subjects information. EVALUATION: (1) Number and percentage of applicants who elect not to submit IRB data - i.e., effort saved; (2) time and effort post-peer review to get IRB data from fundable applicants; and (3) delays in award, if any, due to deferred receipt of IRB data. STUDY 4: ABBREVIATED APPLICATION AMENDMENTS At each meeting of study sections, applications ranging from those with substantial scientific merit and to those of limited scientific merit are reviewed. A portion of applications may be identified by the study section as having high scientific merit but needing limited additional information that, if provided, could substantially improve the scientific merit of these applications. The summary statements of applicants so identified by study section will designate that the applicants have the opportunity to prepare brief responses to the critiques. These abbreviated application amendments would be three-to-five pages directly related to questions and concerns raised during the initial review. Further, these applicants could be provided their summary statements soon after the meeting and would have the opportunity to submit their abbreviated amendments directly to the Scientific Review Administrator of the Study Section for consideration at the next meeting of the TMP study section. Applications reviewed on February 13-14 and June 19-20, 1997 will be considered by the study section for eligibility to submit abbreviated applications. Those selected will be given the opportunity to submit the abbreviated amendment if their original application is not funded by the Institute. Abbreviated amendments will be made available by DRG to study section members for re-evaluation at the next scheduled study section meeting. EVALUATION. Evaluation of the abbreviated application process will include: (1) number of applications identified as eligible for abbreviated amendment; (2) number and percent of applicants who elect to submit abbreviated applications; (3) DRG staff time required by abbreviated amendment process; (4) average change in priority score for abbreviated amendment applications vs. full revision applications; (5) number and percent of abbreviated applications funded; and (6) estimated change in time of award date for funding of resubmission. STUDY 5: EXPEDITED COUNCIL REVIEW AND NIAID AWARD OF TMP GRANT APPLICATIONS. NIAID has WWW-based encrypted password-controlled electronic system in place to (1) provide Council members with summary statements for applications within NIAID paylines as soon as they become available and (2) receive Council comments and complete the second level of review. This allows NIAID to make awards to successful applicants earlier than would otherwise be possible. This NIAID WWW-based system (named Council Action) will access information directly from the electronically-assisted peer review (See Study 2 above) for applications within the NIAID payline and provide it to the NIAID Council for early second level of review to minimize the interval between peer review completion and Council second level of review. EVALUATION: (1) Reduction in time interval between study section meeting and Council review of applications; and (2) acceptability to Council members of electronically-assisted peer review information as basis for performing second level of review of grant applications. INQUIRIES Inquiries regarding review and referral may be directed to: Dr. Suzanne Fisher Referral Section Division of Research Grants 6701 Rockledge Drive, Room 2030 - MSC 7720 Bethesda, MD 20892-7720 Email: fys@drgpo.drg.nih.gov Dr. Jean Hickman Tropical Medicine and Parasitology Study Section Division of Research Grants 6701 Rockledge Drive, Room 4178 - MSC 7808 Bethesda, MD 20892 Email: hmj@drgpo.drg.nih.gov Inquiries regarding the coordination of this effort may be directed to: John J. McGowan,Ph.D. Acting Deputy Director National Institute of Allergy and Infectious Diseases Building 31 Room 7A03 Bethesda, MD 20892 Email: jm80c@nih.gov $$N1 END ************************************************************ $$N2 BEGIN NOT-97-002 FULL-TEXT ************************************* SELF-ONLY HEALTH INSURANCE AND TUITION COSTS ON NIH NRSA POSTDOCTORAL FELLOWSHIP AWARDS -- MODIFIED POLICY NIH GUIDE, Volume 26, Number 1, January 10, 1997 P.T. 34; K.W. 1014006 National Institutes of Health In order to streamline the award of competing National Research Service Award (NRSA) individual postdoctoral fellowships (F32), the NIH hereby modifies the policy regarding payment of self-only health insurance costs articulated in the NIH Guide for Grants and Contracts, Vol. 25, No. 2, February 2, 1996 and again in the Fellowship Guidelines published in Vol. 25, No. 31, September 20, 1996. In these two documents, the NIH stated that beginning with fiscal year 1997 postdoctoral fellowship awards, the NIH would award funds to offset 100 percent of the first $2000 and 60 percent of expenses above $2,000 that are associated with the combined cost of tuition, fees, and self-only health insurance. Because few postdoctoral fellows incur educational costs and self- only health insurance costs are routine and fairly predictable, the NIH has elected to increase the institutional allowance by $1,000 to partially offset the cost of self-only health insurance. Incorporating these costs into a fixed allowance will significantly streamline the issuance of fellowship awards while retaining consistency with the recommendations of the NIH Task Force on NRSA Tuition Policy (this report can be found on the World Wide Web at http://www.nih.gov/grants/oep/tuition.htm). Postdoctoral fellows will still be able to request additional funds for tuition and fees associated with specific courses using the formula stated above. Beginning with competing postdoctoral fellowships awarded in fiscal year 1997, the NIH will provide an institutional allowance of $4,000 per 12-month period to non-federal, non-profit sponsoring institutions to help defray such awardee expenses as self-only health insurance, research supplies, equipment, and travel to scientific meetings. The NIH will provide up to $3,000 for fellows sponsored by Federal laboratories or for-profit institutions for expenses associated with self-only health insurance, travel to scientific meetings, and books. The NIH also will provide additional funds to offset the combined cost of tuition and fees for specific courses, which support the research training experience, at the following rate: 100 percent of all costs up to $2,000 and 60 percent of costs above $2,000. INQUIRIES Inquiries regarding this policy may be directed to: Walter T. Schaffer, Ph.D. Research Training Officer National Institutes of Health 6701 Rockledge Drive, Room 6184 Bethesda, MD 20892-7910 Telephone: (301) 435-2770 FAX: (301) 480-0146 Email: ws11q@nih.gov $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** NATIONAL HUMAN SUBJECT PROTECTIONS WORKSHOPS NIH GUIDE, Volume 26, Number 1, January 10, 1997 P.T. 42; K.W. 0783005 National Institutes of Health Food and Drug Administration The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) are continuing to sponsor a series of workshops on responsibilities of researchers, Institutional Review Boards (IRBs), and institutional officials for the protection of human subjects in research. The workshops are open to everyone with an interest in research involving human subjects. The meetings should be of special interest to those persons currently serving or about to begin serving as a member of an IRB. Issues discussed at these workshops are relevant to all other Public Health Service agencies. The current schedule includes the following: DATES: January 20-21, 1997 TITLE: Challenges for Today's IRBs: Protection of Human Subjects in Research LOCATION: Tempe Mission Palms Hotel, Tempe, AZ, Telephone (602) 894- 1400 SPONSORS: Arizona State University, Tempe, AZ; Samaritan Health System, Tempe, AZ REGISTRATION Ms. Carol Jablonski Coordinator of Regulatory Affairs Office of Human Research Administration Arizona State University Box 878206 Tempe, AZ 85287-8206 Telephone: (602) 965-6788 REGISTRATION FEE: $175 DESCRIPTION: This program is a practical working session to explore contemporary issues in human subjects protection including emergency research, human genome research, uses of special populations, compensation to subjects and finder's fees, certificates of confidentiality, ethical and legal concerns, and conflict of interest and related issues. An outstanding faculty will present topics from the perspective of the clinical researcher or the behavioral and social science research as appropriate. Sessions will provide a panel format with ample time for audience questions and discussion. This program will be of interest to researchers in clinical medicine and the behavioral and social sciences, Institutional Review Board members, university and hospital administrators, lawyers, ethicists, health care practitioners, students, and other persons with interests in human subject protection issues. DATES: February 28 - March 1, 1997 TITLE: Contemporary Issues Involving Risk/Benefit Issues in Research LOCATION: Hyatt Regency New Orleans, 500 Poydras Plaza, New Orleans, LA 70112, Telephone (504) 561-1234 SPONSORS: Tulane University School of Medicine, New Orleans, LA; University of New Orleans, New Orleans, LA REGISTRATION Tulane University Medical Center Continuing Medical Education 1430 Tulane Avenue New Orleans, LA 70112 Telephone: (504) 584-2665 FAX: (504) 586-3892 REGISTRATION FEE: $175 DESCRIPTION: This program is a practical working session to explore issues in human subjects protection related to the following topics: OPRR Regulatory Update; FDA Regulatory Update; The Need for Minorities and Women in Clinical Trails; Ethical and Legal Problems in Socially Sensitive Research; Research on Genetic Markers of Disease: Who Has a Right to Know?; Protecting Human Subjects -- A Historical Perspective; Risk/Benefit Issues in Children and Adolescents; Risk/Benefit Issues Involving Alcoholics and Drug Addicts; and Issues in Mental Illness and Health Research. An outstanding faculty will present topics from the perspective of the health researcher and the health practitioner. Sessions will provide a panel format with ample time for audience questions and discussion. This program will be of interest to researchers, Institutional Review Board members, university and hospital administrators, lawyers, ethicists, health care practitioners, students, and other persons with interests in human subject protection issues. DATES: April 10-11, 1997 TITLE: Science to Practice: The Role of Research in Public Health LOCATION: The Robert W. Woodruff Health Sciences Center, 1440 Clifton Road, NE, Atlanta, GA 30322 SPONSORS: Emory University - School of Public Health, Atlanta, GA; Morehouse School of Medicine, Atlanta, GA; Centers for Disease Control and Prevention, Atlanta, GA REGISTRATION: Emory University School of Medicine Continuing Medical Education 1462 Clifton Road, NE, Suite 276 Atlanta, GA 30322 Telephone: (404) 727-5695 FAX: (404) 727-5667 REGISTRATION FEE: $75 DESCRIPTION: This program is a practical working session to explore issues in human subjects protection related to public health including surveillance, emergency responses, community-based research and international research. An outstanding faculty will present topics from the perspective of the public health researcher and the public health practitioner. Sessions will provide a panel format with ample time for audience questions and discussion. This program will be of interest to researchers in public health, epidemiology, health education, and the behavioral and social sciences, Institutional Review Board members, university and hospital administrators, lawyers, ethicists, health care practitioners, students, and other persons with interests in human subject protection issues. INQUIRIES For further information regarding these workshops or future NIH/FDA National Human Subject Protections Workshops, contact: Ms. Darlene Marie Ross Office for Protection from Research Risks Office of Extramural Research 6100 Executive Boulevard, Suite 3B01 Rockville, MD 20892-7507 Telephone: (301) 496-8101 x233 FAX: (301) 402-0527 Email: RossD@od6100m1.od.nih.gov $$N3 END ************************************************************ $$N4 BEGIN ********************************************************** NCI COOPERATIVE HUMAN TISSUE NETWORK NIH GUIDE, Volume 26, Number 1, January 10, 1997 P.T. 34; K.W. 0715035, 0780005 National Cancer Institute The National Cancer Institute's Cooperative Human Tissue Network (CHTN) provides human tissue for biomedical research. The CHTN provides normal, benign, pre-cancer and cancer tissue. Trained personnel coordinate the retrieval, preservation and delivery of specimens from surgical resection and autopsy. During nine years of operation, the CHTN has supplied more than 100,000 specimens to approximately 600 investigators. Human tissue provided by the CHTN has been utilized for a variety of research projects, such as studies of gene isolation, gene deletion, gene mutation, growth factors, isoenzymes, subcellular organelles, flow cytometry, DNA hybridization and the development of monoclonal antibodies and cell lines. Five member institutions coordinate the collection and distribution of tissues in the US and Canada. Collection, storage and distribution requirements vary with the research approach and tissue type. Studies on M-RNA and labile proteins require snap-frozen surgical tissue stored at ultra-low temperatures. More stable biological molecules allow a wide range of studies on autopsy tissue, including establishing viable tissue cultures and cell lines. Investigators should discuss the tissue requirements for their research, to assure the largest number and range of research specimens. In order for the CHTN to collect and provide quality tissue specimens to meet specific user needs, each investigator is required to complete a detailed tissue request form. This include information about the type and amount of tissue required, tissue preparation, storage, and shipment requirements (e.g., media, snap frozen, sterile). The CHTN makes every effort to tailor collection, storage and shipment to the needs of the investigator. Tissue is provided according to the following priority order: 1. Funded, peer-reviewed investigators, including those from Federal and National laboratories. 2. New investigators and academic investigators developing new research projects. 3. Other investigators. A nominal processing fee of $20 per specimen is charged to cover some of the cost of collecting, preparing, and handling the tissue. In addition, the investigator is responsible for the cost of shipping specimens to his/her laboratory. Application forms will soon be available from the CHTN Internet site at: http://wwwicic.nci.nih.gov/chtn/chtnmain/html. Applications are also available from the division that serves your geographical area: EASTERN DIVISION - The Eastern Division covers the northeast, the area bounded by the western border of Pennsylvania, and the southern border of Maryland and Alaska and Hawaii. University of Pennsylvania Medical Center Philadelphia, PA 19104-4283 Telephone: (215) 662-4570 FAX: 215-614-6554 Email: chtneast@mail.med.upenn.edu MIDWESTERN DIVISION - The Midwestern Division extends from West Virginia and states west of Pennsylvania north to Minnesota and south through Missouri and Canada. The Ohio State University Columbus, OH 43210 Contact: Ms. Carolyn Cordial Telephone: (614) 293-5493 FAX: (614) 293-5851 Email: cordial-1@medctr.osu.edu PEDIATRIC DIVISION - The Pediatric Division operates nationwide. Children's Hospital Columbus, OH 43205 Contact: Ms. Nancy Sachs Telephone: (614) 722-2890 FAX: (614) 722-2897 Email: nsachs@chi.osu.edu SOUTHERN DIVISION - The Southern Division encompasses Kentucky and Virginia and all states south and west of the Carolinas to Texas. University of Alabama at Birmingham Birmingham, AL 35294-0007 Contact: Ms. Katherine Sexton Telephone: (205) 934-6071 FAX: (205) 934-0816 Email: sexton@tp.path.uab.edu WESTERN DIVISION - The Western Division includes the states north of Oklahoma and west of Texas. Case Western Reserve University Cleveland, OH 44106 Contact: Ms. Diane Zorkle Telephone: (216) 844-8538 FAX: (216) 844-8522 Email: dmz2@po.cwru.edu $$N4 END ************************************************************ $$N5 BEGIN ********************************************************** AVAILABILITY OF BIOLOGIC SAMPLES FROM DIABETIC STUDY POPULATION NIH GUIDE, Volume 26, Number 1, January 10, 1997 P.T. 34; K.W. 0780010, 0715075 National Institute of Diabetes and Digestive and Kidney Diseases PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) announces that a portion (1/3) of all stored non-renewable samples (plasma, serum, urine) from subjects enrolled in the Diabetes Control and Complications Trial (DCCT) is available for use by the scientific community to address questions for which these samples may be invaluable. The DCCT was a randomized, controlled clinical trial conducted at 29 centers in the U.S. and Canada. A total of 1,441 patients between the ages of 13 and 39 years with insulin-dependent diabetes for 1-15 years were recruited during 1983 through 1989. Approximately half of these subjects had no retinopathy and half had mild retinopathy. Patients were randomly assigned to conventional or intensive diabetes treatment and followed for a mean of 6.5 years for the appearance and progression of retinopathy and other complications. During the course of the study, blood and urine samples were obtained at baseline and at regular intervals for up to 10 years. Following their analysis, these samples were stored in aliquots at the central laboratory at the University of Minnesota. For each available subject at baseline and yearly intervals thereafter, the NIDDK is prepared to release up to 4.5 ml urine, 1 ml serum, and 1 ml plasma per requestor. The NIDDK will support the costs of aliquotting and distributing these samples from the central laboratory for highly meritorious approved projects. This does not include DNA or lymphocyte samples. Associated clinical and demographic data on patients will be made available from the Biostatistics Center at George Washington University. To request samples from the DCCT, investigators should describe the rationale for the study, the analysis proposed, and specific requirements for the samples and associated data. The request must justify the requirement for these unique and non-renewable samples. That is, the request must state why the research is dependent specifically on the samples from the DCCT and why other sources are insufficient for addressing the research objective. Applicants must also indicate what research funding is available or will be sought to conduct the investigation. Samples will be provided at no cost. If required, investigators will be expected to pay costs associated with data analysis for the retrieval of relevant individual subject data, but not the costs of sample retrieval. Requests will be accepted for two deadlines: February 28, 1997 and July 31, 1997. EVALUATION Requests to utilize samples will be evaluated by a committee organized by the NIDDK to include members of the Epidemiology of Diabetes Interventions and Complications (EDIC) study group, the EDIC Data Coordinating Center, EDIC Central Biochemistry Laboratory, NIDDK staff, and external reviewers. The EDIC study is presently following subjects in the DCCT for macrovascular and microvascular endpoints. Requests will be rated based on the importance of the scientific question being posed, the unique requirement for these samples, the quality and thoroughness of the proposal in outlining the specific hypotheses and methods, and the amount of sample required. Consideration will also be given to the willingness of the investigator to share the samples with other investigators, thereby maximizing the number of investigators using the samples. ACTION Investigators will be advised of committee recommendations in a letter approving or disapproving the release of samples for the proposed investigation. Release of samples will be contingent on documentation that resources are available for the proposed project. If funding for the research project is being sought, samples will be released to the investigator only after funding has been obtained. Approval will be effective for a one year period. Documentation that sufficient funds are available to carry out the work proposed using these samples, and that funds are available to cover any costs associated with patient data retrieval must be provided within one year after approval is received. INQUIRIES Requests are to be directed to: Catherine C. Cowie, Ph.D. IDDM Clinical Trials Program National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 5AN24A Bethesda, MD 20892-6600 Telephone: (301) 594-8804 FAX: (301) 480-3503 Email: cowiec@ep.niddk.nih.gov References o The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. NEJM 1993;329:977-986. o The Diabetes Control and Complications Trial (DCCT): design and methodologic considerations for the feasibility phase. Diabetes 1986;35:530-45. o Diabetes Control and Complications Trial (DCCT): results of feasibility study. Diabetes Care 1987;10:1-19. o Diabetes Control and Complications Trial (DCCT): update. Diabetes Care 1990;13:427-33. o Feasibility of centralized measurements of glycated hemoglobin in the DCCT.: a multicenter study. Clin Chem 1987;33:2267-71. o DCCT protocol. Springfield, VA: Department of Commerce, National Technical Information Service, 1988. (Publication no. 88-116462-AS). o DCCT manual of operations. Springfield, VA: Department of Commerce, National Technical Information Service, 1993. (Publication no. 93-183382.) $$N5 END ************************************************************ $$N6 BEGIN ********************************************************** NINDS REVISED PROGRAM PROJECT GUIDELINES NIH GUIDE, Volume 26, Number 1, January 10, 1997 P.T. 04, 34; K.W. 0710030, 0715138, 1014006, 1002030 National Institute of Neurological Disorders and Stroke The National Institute of Neurological Disorders and Stroke (NINDS) uses program project (P01) and research center (P50) grant mechanisms to encourage multidisciplinary research approaches to investigate and develop scientific knowledge on a diverse array of nervous system disorders. Revised guidelines for the preparation and submission of applications for P01 and P50 grants, including format and sample tables, are now available. Applicants for the February/March 1997 receipt dates and later will be expected to follow this format. These guidelines are to supplement the instructions for the standard grant application form PHS 398 (rev. 5/95). It is NIH policy that applicants for unsolicited new (Type 1) grants who plan to request $500,000 or more direct costs for any year must contact the appropriate NINDS program staff before preparing an application. INQUIRIES The revised guidelines are available on the NINDS Home Page (http://www.ninds.nih.gov) and from the program staff listed below. Dr. F.J. Brinley, Jr. Division of Convulsive, Infectious and Immune Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 5A12 Bethesda, MD 20892 Telephone: (301) 496-6541 FAX: (301) 402-0302 Email: fb18uAnih.gov Dr. Robert Baughman Division of Fundamental Neuroscience and Developmental Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 816 Bethesda, MD 20892 Telephone: (301) 496-5745 FAX: (301) 402-1501 Email: rb175y@nih.gov Dr. Michael D. Walker Division of Stroke, Trauma and Neurodegenerative Disorders National Institute of Neurological Disorders and Stroke Federal Building, Room 8A08 Bethesda, MD 20892 Telephone: (301) 496-4226 FAX: (301) 480-1080 Email: walkermd@nih.gov Inquiries regarding application format or review procedures may be addressed to: Dr. Lillian Pubols Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 9C10 Bethesda, MD 20892 Telephone: (301) 496-9223 FAX: (301) 402-0182 Email: lp28e@nih.gov Inquiries regarding budget and/or grant policy may be addressed to: Mr. Edward Donohue Division of Extramural Activities National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: ed26b@nih.gov $$N6 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN AG-97-002 FULL-TEXT ************************************** RESOURCE CENTERS FOR MINORITY AGING RESEARCH NIH GUIDE, Volume 26, Number 1, January 10, 1997 RFA AVAILABLE: AG-97-002 P.T. 04, FF; K.W. 0710010, 0745027, 0745035 National Institute on Aging National Institute of Nursing Research Letter of Intent Receipt Date: March 7, 1997 Application Receipt Date: April 18, 1997 PURPOSE The National Institute on Aging (NIA) and the National Institute of Nursing Research (NINR) invite core center (P30) grant applications >From qualified institutions for the creation of Resource Centers for Minority Aging Research (RCMARs). The long-range goal for the RCMARs is to decrease the minority/non-minority differential in health and its social sequelae for older people by focusing research upon health promotion, disease prevention, and disability prevention. More basic or clinical research areas will be considered if there is a clear and compelling rationale that they offer the potential to reduce health status differentials. To meet the long-range goal, RCMARs will create a research infrastructure around three objectives: (1) establish a mechanism for mentoring researchers for careers in research on the health of minority elders; (2) enhance diversity in the professional workforce conducting research on the health of minority elders; and (3) develop and deploy strategies for recruiting and retaining minority group members in epidemiological, psychosocial, and/or biomedical research dealing with the health of the elderly. RCMAR funding is not intended for further description of majority/minority health status or access differentials but for ultimately closing that gap. RCMARs are intended to be broadly multi-disciplinary. Interaction among social, behavioral, and clinical sciences is anticipated and encouraged in order to meet Center objectives. 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. The Request for Applications (RFA), Resource Centers for Minority Aging Research, is related to the priority areas of educational and community-based programs, heart disease and stroke, cancer, diabetes and chronic disabling conditions, and clinical preventive services. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Sidney M. Stahl, Ph.D. Behavioral and Social Research Program National Institute on Aging 7201 Wisconsin Avenue, Suite 533 Bethesda, MD 20892-9205 Telephone: (301) 402-4156 FAX: (301) 402-0051 Email: Sidney_Stahl@nih.gov J. Taylor Harden, Ph.D. Extramural Programs National Institute of Nursing Research 45 Center Drive, Room 3AN-12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-6906 FAX: (301) 480-8260 Email: THarden@ep.ninr.nih.gov $$R1 END ************************************************************ $$R2 BEGIN AA-97-004 FULL-TEXT ************************************** COMBINED BEHAVIORAL/PHARMACOLOGIC TREATMENT OF ALCOHOLISM NIH GUIDE, Volume 26, Number 1, January 10, 1997 RFA AVAILABLE: AA-97-004 P.T. 34; K.W. 0404003, 0745070, 0414015 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: March 21, 1997 Application Receipt Date: April 24, 1997 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites applications from institutions wishing to participate in a multi-center, cooperative clinical trial to assess the efficacy of combined behavioral and pharmacologic interventions in the treatment of alcohol dependence. The goal of the research is to determine if improvement in treatment outcomes can be achieved by therapeutic strategies that integrate various combinations of pharmacotherapy and behavioral interventions. One of the behavioral therapies should be a less intensive treatment which could be implemented in a managed care setting. This Request for Applications (RFA) solicits applications for both Clinical Research Units (CRUs) and a Coordinating Center (CC). It is anticipated that up to $2.5 million per year for the first two years and up to $5.0 million per year for years three through six will be available for direct and facilities and administrative costs under this RFA. It is anticipated that: (a) one award for the Coordinating Center will be made for approximately $375,000 per year in years one and two and for approximately $750,000 to 1,000,000 per year in years three through six; (b) six to eight awards for Clinical Research Units will be made of approximately $250,000 per year in years one and two and an average of $500,000 per year in years three through six, with levels adjusted appropriately for the differing requirements of the activities (e.g., recruitment, intervention, followup, and data analysis) in each of the years. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Combined Behavioral/Pharmacologic Treatment of Alcoholism, is related to the priority area of research on alcoholism treatment. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Margaret Mattson, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard, MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0796 FAX: (301) 443-8774 Email: mmattson@willco.nih.niaaa.gov $$R2 END ************************************************************ $$R3 BEGIN OD-97-004 FULL-TEXT ************************************** EDUCATIONAL WORKSHOPS IN INTERDISCIPLINARY RESEARCH NIH GUIDE, Volume 26, Number 1, January 10, 1997 RFA AVAILABLE: OD-97-004 P.T. 42; K.W. 0710030, 0414015, 0417000, 0502000 Office of Behavioral and Social Sciences Research National Center for Research Resources National Institute of Nursing Research National Institute on Drug Abuse National Institute of Dental Research Letter of Intent Receipt Date: March 14, 1997 Application Receipt Date: April 25, 1997 PURPOSE The Office of Behavioral and Social Sciences Research (OBSSR), the National Center for Research Resources (NCRR), the National Institute of Nursing Research (NINR), the National Institute on Drug Abuse (NIDA), and the National Institute of Dental Research (NIDR) invite applications for educational project (R25) grants to develop and conduct short-term (1-2 weeks) educational workshops in interdisciplinary research aimed at social, behavioral, and biomedical researchers in the formative stages of their careers. The NIH sponsoring organizations are jointly issuing this Request for Applications (RFA) to foster cross-disciplinary communication and research collaborations. Grant applications are requested that propose, as their educational objective, the integration of health research across various levels of analysis. These levels can include environmental, social, individual, organ system, cellular, and molecular levels. Special emphasis is placed on facilitating (1) the integration of different fields of social and behavioral sciences research and/or (2) the integration of these areas with the more biological analyses. The short-term goal of this initiative is to encourage social/behavioral and biomedical scientists at an early stage of their careers to learn each other~s methods, procedures, and/or theoretical perspectives. The long-term goal of this RFA is to enable researchers to develop cross-disciplinary collaborations and to submit quality grant applications with interdisciplinary approaches. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Educational Workshops in Interdisciplinary Research, is related to all priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301- 402-2221), the NIH GOPHER (gopher.nih.gov); and by mail and email >From the program contact listed below. Gerdi Weidner, Ph.D. Office of Behavioral and Social Sciences Research National Institutes of Health Building 1, Room 326 - MSC 0183 Bethesda, MD 20892-0183 Telephone: (301) 435-3718 FAX: (301) 402-1150 Email: gerdi_weidner@nih.gov $$R3 END ************************************************************ $$R4 BEGIN CA-97-012 FULL-TEXT ************************************** IMPROVED TECHNOLOGIES FOR PRODUCTION OF FULL-LENGTH HUMAN cDNA NIH GUIDE, Volume 26, Number 1, January 10, 1997 RFA AVAILABLE: CA-97-012 P.T. 34; K.W. 1002008, 0760053, 0755035 National Cancer Institute Letter of Intent Receipt Date: February 15, 1997 Application Receipt Date: April 29, 1997 PURPOSE The National Cancer Institute (NCI) invites applications for the development and application of innovative technologies for efficiently generating representational, full length cDNA libraries. Full length cDNAs are those clones which contain a copy of the entire mRNA sequence from which they were derived. Representational libraries are those libraries that contain at least one cDNA for every mRNA species present in the starting tissue. Ultimately, this new technology must provide an efficient, cost-effective method for generating full length, representational cDNA libraries from tissue samples. These libraries will provide access to full length clones for those investigators who have previously identified important partial clones in other libraries. In addition the clones from these libraries will provide new gene sequences which will aid in gene discovery and gene function assessment. Therefore, investigators may propose to develop novel technologies initially on a small scale or they may propose to further develop existing efficient technologies into a high-throughput system. The most desirable technologies will be those that are easily exportable to the research community. In order to encourage applications proposing innovative, high-risk projects, exploratory/ experimental research grant (R21) mechanism will be used to support meritorious applications. A total of $2.5 million will be available to support approximately 10 awards. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA) Improved Technologies for Production of Full-Length Human cDNA, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH Gopher (gopher.nih.gov) and the NIH Website (http://www.nih.gov), and by mail and e-mail from the program contact listed below. Jennifer Couch, Ph.D. Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 513, MSC 7388 Bethesda, MD 20892-7388 Telephone: (301) 496-1591 FAX: (301) 402-1037 Email: couchj@dcbdcep.nci.nih.gov $$R4 END ************************************************************ $$R5 BEGIN HL-97-001 FULL-TEXT ************************************** HOST FACTORS CONTROLLING INDIVIDUAL SUSCEPTIBILITY TO HIV-ASSOCIATED PULMONARY DISEASE NIH GUIDE, Volume 26, Number 1, January 10, 1997 RFA AVAILABLE: HL-97-001 P.T. 34; K.W. 0715008, 0715165, 0715125 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: March 14, 1997 Application Receipt Date: April 30, 1997 PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites research project grant (R01) applications for support of research on the cellular and molecular mechanisms that influence host susceptibility to HIV-associated lung diseases, including tuberculosis, histoplasmosis, coccidioidomycosis, blastomycosis, Pneumocystis carinii pneumonia, and pulmonary Kaposi's sarcoma. The host factors could include inherited traits, acquired immune responses, and environmental influences. Research could be directed at understanding normal host defenses as a framework for understanding abnormal defenses. Although financial plans for fiscal year 1997 include approximately $2.0 million for the total cost of the program for the first year, award of grants is contingent upon receipt of funds for this purpose. It is anticipated that as many as eight awards will be issued. Investigators without prior R29 or R01 support are encouraged to apply for this RFA and to identify their status in a cover letter. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Host Factors Controlling Individual Susceptibility to HIV-associated Pulmonary Disease, is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Hannah H. Peavy, M.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10018, MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: hannah_peavy@nih.gov $$R5 END ************************************************************ $$P1 BEGIN PA-97-022 FULL-TEXT ************************************** CELLULAR AND MOLECULAR MECHANISMS OF PRIMARY PULMONARY HYPERTENSION NIH GUIDE, Volume 26, Number 1, January 10, 1997 PA AVAILABLE: PA-97-022 P.T. 34; K.W. 1002004, 1002008, 0715115, 0705048 National Heart, Lung, and Blood Institute Office of Research on Women's Health Office of Rare Disease Research PURPOSE The National Heart, Lung, and Blood Institute (NHLBI), the Office of Research on Women's Health, and the Office of Rare Disease Research invite qualified researchers to submit research project grant applications to investigate the cellular and molecular mechanisms of the etiology and pathogenesis of primary pulmonary hypertension (PPH). The purpose of this program announcement is to stimulate basic research using cellular and molecular approaches to studying the development and subsequent progression of PPH. Applicants are required to study patients diagnosed with PPH or to use materials of patient origin. The mechanisms of support for this program announcement are the research project grant (R01) award and First Independent Research Support and Transition (FIRST) (R29) award. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity for setting priority areas. This Program Announcement, Cellular and Molecular Mechanisms of Primary Pulmonary Hypertension, 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 Summary Report: Stock No. 017-001-004730-01) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202/512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221) and NIH GOPHER (gopher.nih.gov), the NIH Website (http://www.nih.gov), and by mail and E-mail from the program contacts listed below. Dorothy B. Gail, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10018 - MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: Gaild@gwgate.nhlbi.nih.gov Carrie P. Hunter, M.D., M.P.H. Office of Research on Women's Health National Institutes of Health Building 1, Room 202 Bethesda, MD 20892-0161 Telephone: (301) 402-1770 FAX: (301) 402-1798 Email: Hunterc@od1tm1.od.nih.gov Stephen Groft, Pharm.D. Office of Rare Disease Research National Institutes of Health 7550 Wisconsin Avenue, Room 618 Bethesda, MD 20892 Telephone: (301) 402-4336 Email: Grofts@nih.gov $$P1 END ************************************************************ $$P2 BEGIN PAR-97-023 FULL-TEXT ************************************* INTERNET CONNECTION FOR MEDICAL INSTITUTIONS NIH GUIDE, Volume 26, Number 1, January 10, 1997 PA AVAILABLE: PAR-97-023 P.T. 15, 18; K.W. 1004017 National Library of Medicine PURPOSE The National Library of Medicine (NLM) is encouraging the development of a communications infrastructure to promote the rapid interchange of medical information nationally and throughout the world. This infrastructure is based upon the Internet, a network of networks, that is a key element in important Federal initiatives in High Performance Computing and Communication (HPCC) and the National Information Infrastructure (NII). Internet access provides health professionals engaged in education, research, clinical care, and administration with a means of accessing remote databases, libraries, NLM's Internet Grateful Med, DOCLINE, and Loansome Doc, of transferring files and images, and of interacting with colleagues throughout the world. To accelerate the pace with which health-related institutions become part of the electronic information web, NLM is offering grants to support institution-wide Internet connections. This PA uses the NLM Resource Grant (G08) mechanism. Indirect costs are not provided. The total project period for an application submitted in response to this PA may not exceed one year. For a single institution, support is available up to $30,000; a group of institutions may receive up to $50,000 to support development of a multi-institution network including extending extant connectivity to outlying sites, or otherwise furthering NLM's goal of expanding information outreach. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Program Announcement (PA), Internet Connection for Medical Institutions, is related to the priority area of surveillance and data systems. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017 001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-0325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 11 January 1997 Date: 15 Jan 1997 16:07:42 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 81 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bjrge$oko@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending January 11, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: General Publication Title: NSF 97-47--Office of Multidisciplinary Activities (OMA) Mission Statement File size (bytes): 2385 STIS Filename: nsf9747.txt Document Type: International Document Title: INT 97-1 NSF/Europe Report No. 85 Science in Lithuania File size (bytes): 30211 STIS Filename: int971.txt Document Type: Program Guideline Title: NSF 97-20 Elementary, Secondary, and Informal Education File size (bytes): 243990 STIS Filename: nsf9720.txt Document Type: Recruit Title: Program Director File size (bytes): 7107 STIS Filename: vex973a.txt Title: Program Director File size (bytes): 6559 STIS Filename: vex974a.txt Title: Biological Science Administrator (Assistant Program Director of Associate Program Director) File size (bytes): 13856 STIS Filename: vex977.txt Title: Public Affairs Specialist File size (bytes): 9196 STIS Filename: vgs9725.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vex973.txt, the text of your message should be as follows: get vex973.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vex973.txt, you would enter: ftp> get vex973.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AA-97-004 - V26(01) 01/10/97 Date: 16 Jan 1997 14:09:43 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1062 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bm8v7$gi2@net.bio.net> NNTP-Posting-Host: net.bio.net COMBINED BEHAVIORAL/PHARMACOLOGIC TREATMENT OF ALCOHOLISM NIH GUIDE, Volume 26, Number 1, January 10, 1997 RFA: AA-97-004 P.T. 34; K.W. 0404003, 0745070, 0414015 National Institute on Alcohol Abuse and Alcoholism Letter of Intent Receipt Date: March 21, 1997 Application Receipt Date: April 24, 1997 PURPOSE The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites applications from institutions wishing to participate in a multi-center, cooperative clinical trial to assess the efficacy of combined behavioral and pharmacologic interventions in the treatment of alcohol dependence. The goal of the research is to determine if improvement in treatment outcomes can be achieved by therapeutic strategies that integrate various combinations of pharmacotherapy and behavioral interventions. One of the behavioral therapies should be a less intensive treatment which could be implemented in a managed care setting. This Request for Applications (RFA) solicits applications for both Clinical Research Units (CRUs) and a Coordinating Center (CC). HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), for a multisite study of Combined Behavioral/Pharmacologic Treatment of Alcoholism, is related to the priority area of research on alcoholism treatment. 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 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. This RFA is for both Clinical Research Units (CRUs) and a Coordinating Center (CC). Separate applications are required for each. Awards for Clinical Research Units and the Coordinating Center under this RFA will not be made to the same Principal Investigator, although the same institution may apply for both. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a clinical research cooperative agreement (U10), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." The total project period for applications submitted in response to the present RFA may not exceed 6 years. The anticipated award date is September 1997. At this time, the NIAAA has not determined whether or how this solicitation will be continued beyond the present RFA. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the sizes of awards will vary. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is in the financial plans of the NIAAA, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. FUNDS AVAILABLE It is anticipated that up to $2.5 million per year for the first 2 years and up to $5.0 million per year for years 3-6 will be available for direct and facilities and administrative costs under this RFA. It is anticipated that:(a) one award for the Coordinating Center will be made for approximately $375,000 per year in years 1 and 2 and for approximately $750,000 to 1,000,000 per year in years 3-6, (b) 6-8 awards for Clinical Research Units will be made of approximately $250,000 per year in years 1-2, and an average of $500,000 per year in years 3-6, with levels adjusted appropriately for the differing requirements of the activities (e.g., recruitment, intervention, followup, and data analysis) in each of the years. RESEARCH OBJECTIVES Background Important advances have been made in the development of both medications and behavioral interventions to treat alcoholism. Among the medications are naltrexone, nalmefene, and acamprosate. The behavioral interventions include motivationally based, targeted behavioral strategies and interpersonal support treatments. These two types of treatments are not competitive and may enhance each other. Pharmacotherapies may reduce craving for alcohol and/or the reinforcement experienced by drinking alcohol. Behavioral therapies provide skills for patients to maintain sobriety for extended periods of time. Combinations of the two may improve outcome over either modality alone. Recent research is consistent with this and indicates that pharmacologic agents can be combined effectively with behavioral interventions and that their combination enhances treatment outcome. Based on accumulating evidence in the literature, it is appropriate at this time to consider a systematic large scale study of the benefits of combined pharmacologic and behavioral interventions. Relevant literature is summarized below. Promising Pharmacologic Therapies Over the past decade research on medications to treat alcoholism has rapidly expanded (Litten et al., 1996). In particular, advances have been made in understanding the biology underlying drinking behavior, thereby suggesting new possibilities for pharmacologic treatments. For example, it is now known that multiple neurotransmitter systems are involved in problem drinking. These include opioid, serotonin, dopamine, gamma-aminobutyric acid (GABA), and glutamate systems. Several medications that affect these neurotransmitter systems have been tested in humans, including opioid antagonists, selective serotonin reuptake inhibitors, 5-HT3 antagonists, 5-HT2 antagonists, 5-HT1A agonists, dopamine agonists, and GABAergic agents. Currently, the two most promising and reasonably well researched medications are naltrexone and acamprosate. Two landmark clinical trials of naltrexone (Volpicelli et al., 1992 and O'Malley et al., 1992) with alcohol dependent patients produced similar results. Analysis of data combined from the two studies showed that the rate of abstinence for the 12-week trials was 54 percent for the naltrexone group contrasted with 31 percent for the placebo group (O'Malley et al., 1995). If drinking was initiated, the rate of relapse to heavy drinking of the placebo-treated subjects was twice that of the naltrexone group. A possible explanation is that naltrexone blocks the reinforcing effects of alcohol. Naltrexone-treated patients spent 3.1 percent of their days drinking in contrast to 7.5 percent for those on placebo. Finally, craving for alcohol was lower for the naltrexone group than for placebo-treated subjects. In December 1994, naltrexone was approved by the Food and Drug Administration (FDA) for the adjunctive treatment of alcoholism. This is the first medication so designated in over 50 years since the approval of disulfiram. Within the past year, Canada and Austria also approved naltrexone as a treatment for alcoholism. Acamprosate (calcium acetylhomotaurinate) has been studied extensively in Europe. Paille et al., (1995) conducted a 31-site trial of acamprosate in which 538 alcohol dependent patients received either 1.3 g/day or 2.0 g/day or placebo for 1 year. At the end of 6 months, abstinence was sustained in 32 percent of the high dose acamprosate group, in 27 percent of the low dose acamprosate group, and in 19 percent of the placebo group. At the end of 1 year, approximately 19 percent maintained sobriety versus 11 percent of placebo-treated subjects. In addition, treatment retention was significantly higher for both acamprosate groups. Acamprosate produced no major adverse effects. The most common side effect was diarrhea. Whitworth et al., (1996) completed a study with 455 alcohol dependent patients. At the end of the 1 year treatment, 18 percent of acamprosate-treated patients had been abstinent in contrast with 7 percent of placebo-treated subjects. One year after termination of treatment the acamprosate group still demonstrated a significantly higher rate of abstinence than did the placebo group (12 percent versus 5 percent). Sass et al., (1996) reported results from a 12-site study with 272 detoxified alcohol dependent patients. Following 48 weeks of treatment, 43 percent of the acamprosate-treated subjects had sustained sobriety versus 21 percent for the placebo group. The side-effect profiles were identical for acamprosate- and placebo-treated subjects. Mann et al., (1995) analyzed pooled European data consisting of over three thousand alcohol dependent subjects from 11 independent acamprosate studies. The acamprosate group had significantly more sustained abstinence, better treatment retention, and those who drank did so on significantly fewer days than did the placebo-treated subjects. The site of action of acamprosate is different from that of naltrexone, an opioid antagonist. Although the precise mechanism of action is still under investigation, it appears to interact with excitatory amino acids, such as glutamate, and the inhibitory GABA system. Research is needed to determine if the combination of naltrexone and acamprosate will improve treatment outcome. Promising Behavioral Interventions Recently, Project MATCH findings showed marked differences in drinking pre- and post-treatment for three therapies: Cognitive Behavioral Therapy, Motivational Enhancement Treatment, and Twelve Step Facilitation (Project MATCH Research Group, in press). It would be highly desirable to build on these findings and to consider using one or more of the MATCH treatments in the proposed trial. These interventions have demonstrated good retention, patient acceptability and feasibility of implementation. These treatments have been fully described in published therapist manuals which have received wide distribution in the treatment community. Controlled investigations of other behavioral treatments for alcohol problems have been comprehensively reviewed by Hester and Miller (1995). Following review of almost 200 such trials, these commentators identified interventions which offered good evidence for efficacy. Among these were: brief intervention, social skills training, motivational enhancement, and behavior contracting. Social skills training and motivational enhancement techniques were incorporated into the Project MATCH therapies. While other verbal therapies have evidence for their efficacy, none have been studied in a multisite, large sample study as have the three MATCH therapies. Social skills training employs behavioral techniques such as instruction, prompting, practice, and feedback to enhance the patient's general repertoire of interpersonal relationship skills as well as ability to cope with peer pressure that may induce drinking. Motivational enhancement techniques include non-confrontational interviewing of patients, feedback in an attempt to deepen their awareness of need for change, reinforcement of their commitment to and sense of self efficacy for positive change, and establishment of personal goals. Brief intervention is generally undertaken in a primary care setting. While there are many variants of what has been termed "brief intervention," Bien et al., (1993) state that effective brief interventions are characterized by several elements encompassing feedback and patient responsibility for change. Finally, behavior contracting, as the name implies, involves establishing written agreements with the patient to achieve specific goals in treatment or practice a treatment element, such as attend aftercare sessions, complete extra-treatment "homework" assignments, or take disulfiram. Often a significant other also signs the contract. This technique could be utilized as a procedure to enhance compliance with therapy and medications. Research Questions The objective of this study is to conduct a prospective, multi-center cooperative clinical trial to assess the efficacy of combined behavioral and pharmacologic interventions in the treatment of alcohol dependence. It is envisioned that the study will test two behavioral interventions (one of moderate intensity and the other of minimal intensity which would be practical for use in managed care settings and may be either group or individual settings therapy) crossed with two individual pharmacologic agents, the combination of the two agents, and placebo, resulting in an eight cell design. Applicants should address the research questions that flow from this design. Examples of relevant questions include, but are not limited to, the following questions: 1) Can improvement in treatment outcomes be achieved by combining behavioral interventions with pharmacotherapy; 2) Does the relative efficacy of particular combinations of behavioral-pharmacologic therapies differ; 3) Is a moderate intensity behavioral intervention more effective than a more minimal intervention; 4) Does combining two pharmacotherapies lead to greater improvements in outcome than that achieved by use of either of the agents singly; and 5) Are different types of alcoholic patients likely to be more responsive to behavioral or pharmacologic intervention in general as well as to specific types of medicational and behavioral interventions in combination. Outline of Study Design To address the research questions of this program, the application should include, at a minimum, the following major components: 1) A study design which is double blind, placebo controlled, utilizing two medications, such as naltrexone and acamprosate and two behavioral therapies. One behavioral therapy should be a MATCH treatment or one based on a MATCH treatment and the other should be a less intense treatment which could be implemented in a managed care setting. The behavioral interventions may be in either individual or group formats. Strategies should be developed for enhancing compliance with medication and behavioral treatments. Abstinence should be the goal of the interventions. 2) Duration of active treatment should be at least 6 months and minimum follow-up should be at least 1 year post treatment. 3) A comprehensive assessment battery should include as a minimum, instruments to: evaluate patients' drinking history, establish appropriate diagnosis, measure patient variables, e.g., family history likely to be associated with responsivity to current treatment, and assess compliance with treatment, and evaluate drinking outcome. Biochemical markers to validate consumption should be selected. Applicants should strive for practicality and efficiency in their use of markers and collaterals. One of the primary outcomes to be measured is abstinence. 4) Applicants should develop a plan for augmenting the treatment of patients who are nonresponders to the initial medication and psychotherapy combinations, including objective criteria to define nonresponse. 5) The study should be conducted with an outpatient population who meet criteria for alcohol dependence, but who do not meet criteria for current major depression or drug abuse except for nicotine, caffeine, or marijuana. 6) Study duration should be 6 years including the 12 months for a preliminary study. 7) Applicants also should identify and develop a preliminary study to be conducted in months 7-18 related to the study research questions listed above. Examples of such preliminary studies include, but are by no means restricted to, medication compliance management, and issues related to drug administration such as dosing and patient acceptance. The total cost for the preliminary study proposed should not exceed $300,000 including facility and administrative costs, and the duration should not exceed 12 months. Specific hypotheses for the preliminary study, design, and assessment are left to the discretion and creativity of the applicants. Final determinations concerning the nature, scope and timing of the specific preliminary study (or studies) will be made by the Steering Committee during the initial planning period. Elaboration of the Model Study Design Although the outline of a model strategy is given above, applicants should develop and fully elaborate the key elements of the study design such as: 1) Research question and detailed plan for the preliminary study; 2) Nature of the behavioral interventions for the main study; 3) Estimates of sample size for the main study; 4) Details of assessment battery for the main study; 5) Details of the plan for treatment augmentation of nonresponders in the main study; and 6) Data analysis plan. Final Protocol Development In keeping with the goals of the cooperative agreement mechanism, the protocol will be discussed by the Steering Committee, composed of awardees and NIAAA staff. After awards are made the Steering Committee may collaboratively develop a study protocol that differs from the model outlined here (e.g., a different design, alternative drugs, etc)provided the research questions of the RFA are addressed and the Institute agrees that the resultant design is still within the general scope and will serve the purposes described in this RFA. After awards are made participating institutions will collaborate to develop and then follow a mutually acceptable common study protocol with standardized study design, data collection procedures, and intervention approaches. The collaborative protocol will be developed during the first 6 months of the study by the Steering Committee of the study. Coordinating Center In addition to the CRUs, a Coordinating Center will be needed to: (1) organize and provide logistical support for Steering Committee meetings and relevant Executive Secretariat functions; promote communication across sites, including preparation and distribution of meeting minutes and support for the work of trial committees, such as conference call arrangements and distribution of minutes; (2) coordinate the development of trial wide forms, procedures and training exercises; design and maintain a manual of operations; (3) monitor quality control of treatment delivery and data collection; (4) monitor and support enrollment, randomization and follow up activities; (5) design, document, and assemble the data base resulting from the common protocol; (6) perform core trial wide analyses in a centralized manner; (7) coordinate analyses done in a decentralized manner to avoid overlap and assure continuity and quality; (8) procurement, packaging and distribution of the drugs and their matched placebos; (9) application, on behalf of the CRUs, for any necessary IND approval; and (10) establish a centralized and standardized mechanism for performance of bioassays. TIMETABLE Phase 1: The first 6 months of the collaborative effort will be devoted mainly to developing a common protocol, developing the necessary training and implementation procedures, finalizing manuals to ensure cross-site consistency in study execution and identifying the essential preliminary study or studies. Phase 2: In months 7-18 the preliminary study (or studies) will be implemented and completed, based on decisions made by the Steering Committee; in months 18-24 the protocol for the main trial will be finalized. Phase 3: In months 19 through 60 the recruitment for the main study, delivery of treatments, and follow-up will be done. In year 6 data will be analyzed and manuscripts written. SPECIAL REQUIREMENTS This section summarizes special scientific considerations that must be addressed in the applications for Clinical Research Units, in addition to other elements of the research plan. 1. The application should include a proposed protocol that meets the objectives and scope outlined in this RFA and responds to the required major components as stated in the "Research Questions" and "Study Design" sections. Award of the cooperative agreement does not imply that any particular proposed protocol will be implemented. Since the final study will be designed by the Steering Committee, the final protocol may not reflect any single proposal submitted in response to this RFA. 2. Applicants should identify and develop a preliminary study. Specific hypotheses for the preliminary study, details of the study design, and assessment are in the hands of the investigator. This preliminary study should not exceed 12 months in duration. 3. Applicants should develop a plan for augmenting the treatment of patients who are nonresponders to the initial medication and psychotherapy combinations, including objective criteria to define nonresponse. TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator(s) as well as the institutional official at the time of award. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a clinical research cooperative agreement (U10), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NIAAA project staff. Details of the roles of the parties are described later in this section. A. Awardee Rights and Responsibilities Awardees will have primary and lead responsibilities for the project as a whole including protocol development, participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, preparation of publications, as well as collaboration with other awardees and with assistance from NIAAA staff. The Principal Investigator defines the details for the project in accordance with these Terms and Conditions of Award; retains primary responsibility for the performance of the activity; and agrees to close coordination, cooperation, and assistance of NIAAA extramural staff in aspects of scientific and technical management of the project as described herein. 1. Steering Committee Membership and Meeting Attendance Each Principal Investigator (or designee) will be responsible for attending all Steering Committee meetings. The Steering Committee will meet five times in year 1 and four times yearly in subsequent years. The Steering Committee shall be responsible for determining the frequency and scheduling of meetings. Each Principal Investigator (or designee) will be expected to participate in all other Steering Committee activities, e.g., conference calls, special subcommittees as may be necessary, etc. 2. Role of Clinical Research Units Each awardee institution and its corresponding investigators will be responsible for developing and implementing research aims; adjusting research priorities in accordance with current developments and available budget funds; participating in analyses; and accepting the participatory and cooperative nature of the group process and policies relevant to this program. 3. Role of the Coordinating Center In addition to the CRUs, a Coordinating Center will be needed to: (1) organize and provide logistical support for Steering Committee meetings and relevant Executive Secretariat functions; promote communication across sites, including preparation and distribution of meeting minutes and support for the work of trial committees, such as conference call arrangements and distribution of minutes; (2) coordinate the development of trial wide forms, procedures and training exercises; design and maintain a manual of operations; (3) monitor quality control of treatment delivery and data collection; (4) monitor and support enrollment, randomization and follow up activities; (5) design, document, and assemble the data base resulting from the common protocol; (6) perform core trial wide analyses in a centralized manner; (7) coordinate analyses done in a decentralized manner to avoid overlap and assure continuity and quality; (8) procurement, packaging and distribution of the drugs and their matched placebos; (9) application, on behalf of the CRUs, for any necessary IND approval; and (10) establish a centralized and standardized mechanism for performance of bioassays. B. NIAAA Staff Responsibilities The NIAAA staff role in this cooperative agreement will extend beyond the level normally required for stewardship of a grant because of the need for coordination of study protocols among performance sites, technical assistance in the analysis of data, and monitoring and possible reassessment of project objectives as the study proceeds. The NIAAA extramural staff perform different functions in research projects supported under the cooperative agreement mechanism. 1. Program Official The Program Official provides normal stewardship of the award and has overall responsibility for monitoring the conduct, progress, and fiscal management of the program. Progress of the project will be reviewed by the Program Official annually at the time of each continuation application to assure that satisfactory progress is being made in achieving the objectives of the project and that each performance site is following the program goals and procedures recommended for use by all participants in the cooperative program and approved by the Steering Committee. 2. NIAAA Staff Collaborator The NIAAA Staff Collaborator has substantial scientific input in collaboration with award recipients, in both planning and conduct of the research. The NIAAA Staff Collaborator will (1) participate as a voting member on the Steering Committee which oversees this research effort, the Executive Committee and relevant technical subcommittees or working groups as appropriate; (2) participate in the formulation of protocols and other planning related to the completion of the research; and (3) participate in monitoring the progress of the research and quality control, and (4) the analysis and interpretation of data, and possibly in associated publications and presentations. 3. NIAAA Senior Scientific Advisor The NIAAA Senior Scientific Advisor will advise on policy, budget, and technical matters relating to trial conduct. 4. NIAAA Consultants for Behavioral and Pharmacologic Treatments The consultants will advise on technical issues related to these topics, serve on working committees, attend Steering Committee meetings, and participate in analyses and publications. The NIAAA staff will be subject to the same publication/authorship policies governing all participants in the study, as well as to the official NIH Publication Policy governing extramural employees. C. Collaborative Responsibilities 1. Governance/Steering Committee A Steering Committee will be the main governing board of the study and will have primary responsibility for all scientific decisions. The Steering Committee will be composed of the Principal Investigator (or designee) of each Clinical Research Unit, the Coordinating Center, and the NIAAA Staff Collaborator. Each will have one vote, should a vote of the Steering Committee be necessary to make a decision. The functions of the Steering Committee include: defining protocol objectives and approaches; designing and implementing the consensus protocol; developing procedures for data collection and management and quality control; establishing procedures for assessing performance with respect to accrual, timely submission and quality of data, and conscientious observance of protocol requirements; analyzing and interpreting study data; and publishing/presenting study findings. The Steering Committee also approves the preliminary study (studies) based on studies approved during initial peer review. Each member of the Steering Committee will have one vote. The chairperson will be selected by the Steering Committee from among the non-NIAAA members. Subcommittees will be commissioned and monitored by the Steering Committee, as it deems appropriate. Subcommittees will report to the Steering Committee and will function under the direction of the Steering Committee. Additional representatives of NIAAA's Treatment Research Branch may participate as members of subcommittees. A subset of the Steering Committee will be elected by the group to serve as an Executive Committee which will meet via conference call on a regular basis (i.e., weekly or biweekly) between meetings of the full Steering Committee. Both the NIAAA and the Coordinating Center will be represented on the Executive Committee. The collaborative protocols will be developed by the Steering Committee. Data will be submitted centrally according to a specified schedule to the Coordinating Center. Protocols will define rules regarding access to data and publications. By acceptance of this award, awardees will be required to accept and implement the common protocol, procedures and policies approved by the Steering Committee. 2. Data Coordination and Management To insure consistency and timeliness, the content, methods and timetable of core analyses will be stipulated in advance by the Steering Committee and will be performed by the Coordinating Center. No data relating to the core analyses from the trial-wide merged data set will be distributed to individual CRUs until these core analyses are completed. Awardees will retain custody of and primary rights to their data under these awards subject to Institute rights of access, consistent with current HHS, PHS, and NIH policies. Applicants are encouraged to plan to publish their findings in a timely manner and to make the data available to the scientific community in a timely way at the end of the grant period. The trial-wide data set, consisting of the pooled data from all sites, is considered the common data base to which all investigators contribute and have access to. Details of the Publication Policy will be developed by the Steering Committee and will be binding upon members. The Steering Committee will define a key set of publications on the main trial findings which will be authored by the Project Research Group as a whole, with individual investigators precluded from preempting such trial-wide, corporate publications. Review and approval by the Steering Committee will be required for all analyses prior to the publication or presentation according to criteria that will be developed by the Committee. D. Monitoring Study Progress 1. The Steering Committee will establish mechanisms for assessing performance of the CRUs, with particular attention to accrual of adequate numbers of eligible patients, timely submission and quality of required data, and conscientious observance of protocol. 2. The Data and Safety Monitoring Board (DSMB) is an independent board of experts established by the NIAAA which oversees the integrity of data and safety of clients. The Institute convenes the DSMB twice a year. Its major function is to review reports of patient safety and data integrity on a regular basis. The Board is also responsible for reviewing and approving the final protocol prior to the start of the recruitment phase, and for approving the progression from one phase of the trial to the next. E. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIAAA may be brought to arbitration. An arbitration panel will be composed of three members; one selected by the Steering Committee (with the NIAAA member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NIAAA, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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. LETTER OF INTENT Prospective applicants are asked to submit, by March 21, 1997, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, identities of other key personnel and participating institutions, and number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows the NIAAA staff to estimate the potential review workload and to avoid conflict of interest in the review. A separate letter of intent must be submitted for applications for the Clinical Research Units and the Coordinating Center. The Letter of Intent is to be sent to: RFA-AA-97-004 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-4375 FAX: (301) 443-6077 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Applications must address the requirements as outlined in study design, research objectives, special requirements and terms, and conditions. Additional Materials to Include in the Application 1. All costs required for the proposed protocol must be included in the application and must be fully justified. Requested budgets should include travel to the Washington, D.C. area for four 2 day Steering Committee meetings each year during the duration of the trial, except for the first year when five meetings may be required. The acquisition and packaging of the drugs will be handled by the Coordinating Center. Thus CRU applicants need not address this in their application's budget section. The Coordinating Center should include in its budget an estimated cost for drugs of approximately $300,000 per year for years 3, 4 and 5. For budget year 06, applicants should put the 06 budget year on an additional copy of form page 5EE of the PHS 398 application. 2. The applicant institution and each participating institution associated with an applicant consortium must document their experience and capacity to recruit and retain study participants, provide a description of the population currently available for the proposed protocol (including yearly figures on numbers of patients screened, treated, and discharged), and describe proposed mechanisms for recruiting a minimum of 75 patients per year and monitoring accrual performance and criteria for continued participation by each institution contributing patients. 3. The application should discuss the capability of the applicant organization to participate and interact effectively in multi-center clinical trials. 4. The application must include a written commitment to accept the participation and assistance of NIAAA staff in accordance with the guidelines outlines under "NIAAA Staff Responsibilities" as stated above. The application must also include a written commitment to the cooperative organization and willingness to serve on the Steering Committee and adhere to the decisions reached by that Committee, including following a consensus protocol. 5. The application for a CRU must name a single Principal Investigator (PI) who will have scientific responsibility for the application as a whole including all research activities included under it. Applications from a consortia of institutions must name a single senior Investigator for each participating institution (other than the applicant institution) who will be responsible for on-site scientific direction and implementation for the consensus protocol. Senior Investigators in consortia must also document relevant experience in alcoholism treatment research. 6. The application must provide a clear concise plan showing the scientific discipline of the PI and of all key scientific, technical and administrative personnel, and a mechanism for replacing key professional or technical personnel should the need arise. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies, in one package 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/courier service) At the time of submission, two additional copies of the application must also be sent to: RFA-AA-97-004 Office of Scientific Affairs National Institute on Alcohol Abuse and Alcoholism Willco Building, Room 409 6000 Executive Boulevard MSC 7003 Bethesda, Maryland 20892-7003 Rockville, Maryland 20852-7003 (for express/courier service) Applications must be received by April 24, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. REVIEW CONSIDERATIONS All applications will be judged on the basis of the scientific merit of the proposed project and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Although the scientific and technical merit of the proposed protocol is important, it will not be the sole criterion for evaluation of a study. Other considerations, such as the relevance and importance of the preliminary study proposed, access to patients, and understanding of the nature of a cooperative agreement and the complex requirements of a multisite trial will also be taken into account. Review Method Upon receipt, applications will be reviewed for completeness by the DRG and responsiveness by the NIAAA. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Institute in accordance with the review criteria stated below. As part of the initial merit review, a streamlined review process may be used by the initial review group in which applications may or may not be discussed based on their scientific merit relative to other applications received in response to the RFA. Applications which are fully discussed will be assigned a priority score. Applications which are not discussed will be withdrawn from further considerations and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Council on Alcohol Abuse and Alcoholism. Review Criteria The major functional units in the trial are the Clinical Research Units (CRUs) and the Coordinating Center (CC). The review criteria for each are described below. Note that an institution may submit an application for a CRU and/or the CC, but no individual PI may serve as both a CRU PI and the CC PI. A separate application is required for each. Factors to be considered in evaluating the scientific and technical merit of applications for Clinical Research Units are: (1) responsiveness to the goals of the RFA and the scientific and technical merit of the approach proposed for the key elements of the main study design, including nature of the behavioral interventions; estimates of sample size; details of the assessment battery; plans for the argumentation of treatment for nonresponders and data analysis. (2) the scientific merit, creativity and relevance of the proposed preliminary study; (3) scientific qualifications and research experience of the principal investigator and other key research personnel to conduct a pharmacologic-behavioral clinical trial and adequacy of their time commitment to the cooperative program; (4) adequacy of facilities and resources, including computer facilities; (5) documented access to a sufficient number of subjects (at least 75 per year) and established treatment sites and ability to retain subjects; (6) understanding of the scientific, logistical, and technical issues underlying a multicenter collaborative agreement and previously demonstrated expertise in closely coordinating with fellow investigators and recruiting sites; (7) adequacy of provisions for the protection of human subjects; (8) adequacy of the plans for the inclusion of both genders and minorities in the project; and (9) appropriateness of budget estimates for the proposed activities. Criteria for scientific merit review of applications for the Coordinating Center include: (1) soundness of the proposed plans for the administrative management and coordination of the trial, including support of the Steering Committee and working committees; (2) adequacy of the plan for administrative structure within the Coordinating Center and methods for coordination with the performance sites; (3) appropriateness of the plans for: collecting and maintaining data; establishing an appropriate database and assuring data integrity; instructing field staff on the correct use of research protocols; and monitoring adherence to research design specifications; (4) appropriateness of plans for: (a) implementation of analyses of trial wide core analyses, based on decisions made by the Steering Committee and (b) distribution of the trialwide data set to CRU's including methods and policy considerations; (5) experience, competence, willingness, and availability of the Principal Investigator and other key personnel to perform the functions of the Coordinating Center, including expertise in statistics, data management, administration of large scale multisite studies, conduct of pharmacologic studies, including drug handling and IND procedures, management of centralized bioassay performance, and training and supervision of therapists; (6) availability and adequacy of facilities relating to data management, data analysis, and other needed resources; (7) reasonableness of budget estimates for the proposed activities; and (8) adequacy of procedures for the protection of human subjects. AWARD CRITERIA Applications recommended by the National Advisory Council on Alcohol Abuse and Alcoholism will be considered for award based upon scientific and technical merit; program balance, including in this instance, sufficient compatibility of features to make a successful collaborative program a reasonable likelihood; and availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcomed. Direct inquiries regarding programmatic issues to: Margaret Mattson, Ph.D. Division of Clinical and Prevention Research National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard - MSC 7003 Bethesda, MD 20892-7003 Rockville, MD 20852-7003 (for express/courier service) Telephone: (301) 443-0796 FAX: (301) 443-8774 Email: mmattson@willco.nih.niaaa.gov Direct inquiries regarding fiscal matters to: Linda Hilley Grants Management Branch National Institute on Alcohol Abuse and Alcoholism 6000 Executive Boulevard MSC 7003 Bethesda, MD 20892-7003 Telephone: (301) 443-0915 FAX: (301) 443-3891 Email: lhilley@willco.niaaa.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.273. Awards are made under the authorization of the Public Health Service Act, Sections 301 and 464H, and administered under the PHS policies and Federal Regulations at Title 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. 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. References Bien, T.H., Miller, W.R., and Tonigan, J.S. (1993). Brief interventions for alcohol problems: A review. Addiction, 88, 315-336. Hester, R.K. and Miller, W.R. (1995). Handbook of Alcoholism Treatment Approaches: Effective Alternatives, Hester, R.K. and Miller, W.R. (Eds.). Allyn & Bacon, Needham Heights, MA. Litten, R.Z., Allen, J., and Fertig, J. (1996). Pharmacotherapies for alcohol problems: A review of research with focus on developments since 1991. Alcoholism: Clinical and Experimental Research 20(5):859-876. Mann, K., Chabac, S., Lehert, P., Potgieter, A., and Sass, H. Acamprosate improves treatment outcome in alcoholics: A pooled analysis of 11 randomized placebo controlled trials in 3338 patients. Presented at 34th Annual Meeting of American College of Neuropsychopharmacology, San Juan, Puerto Rico, December 1995. O'Malley, S.S., Jaffe, A.J., Chang, G., Schottenfeld, R.S., and Meyer, R.E. (1992). Naltrexone and coping skills therapy for alcohol dependence: A controlled study. Archives of General Psychiatry 49:881-887. O'Malley, S.S., Croop, R.S., Wroblewski, J.M., Labriola, D.F., Volpicelli, J.R. (1995). Naltrexone in the treatment of alcohol dependence: A combined analysis of two trials. Psychiatric Annuals 25: 681-688. Paille, F.M., Guelfie, J.D., Perkins, A.C., Royer, R., Steru, L. and Parot, P. (1995). Double-blind randomized multicentre trial of acamprosate in maintaining abstinence from alcohol. Alcohol and Alcoholism, 30, 239-247. Project MATCH Research Group (in press). Matching Alcoholism Treatments to Client Heterogeneity: Project MATCH Post-treatment Drinking Outcomes. Journal of Studies on Alcohol. Sass, H., Soyka, M., Mann, K., and Zieglgansberger, W. (1996). Relapse Prevention by Acamprosate: Results from a placebo-controlled study on alcohol dependence. Archives General Psychiatry, 53, 673-680. Volpicelli, J.R., Alterman, A.I., Hayashida, M., O'Brien, C.P.(1992). Naltrexone in the treatment of alcohol dependence. Archives of General Psychiatry 49: 876-880. Whitworth, A.B., Fischer, F., Lesch, O.M., Nimmerrichter, A., Oberbauer, H., Platz, T., Potgieter, A., Walter, H. and Fleischhacker, W.W. (1996). Comparison of acamprosate and placebo in long-term treatment of alcohol dependence. Lancet, 347(9013), 1438-1442. From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA HL-97-001 - V26(01) 01/10/97 Date: 16 Jan 1997 14:10:38 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 701 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bm90u$gs2@net.bio.net> NNTP-Posting-Host: net.bio.net HOST FACTORS CONTROLLING INDIVIDUAL SUSCEPTIBILITY TO HIV-ASSOCIATED PULMONARY DISEASE NIH GUIDE, Volume 26, Number 1, January 10, 1997 RFA: HL-97-001 P.T. 34; K.W. 0715008, 0715165, 0715125 National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: March 14, 1997 Application Receipt Date: April 30, 1997 THIS RFA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS RFA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS AND MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The National Heart, Lung, and Blood Institute (NHLBI) invites research grant applications for support of research on the cellular and molecular mechanisms that influence host susceptibility to HIV-associated lung diseases, including tuberculosis, histoplasmosis, coccidioidomycosis, blastomycosis, Pneumocystis carinii pneumonia, and pulmonary Kaposi's sarcoma. The host factors could include inherited traits, acquired immune responses, and environmental influences. Research could be directed at understanding normal host defenses as a framework for understanding abnormal defenses. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Host Factors Controlling Individual Susceptibility to HIV-associated Pulmonary Disease, is related to the priority area of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (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 or local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. All current policies and requirements that govern the research grant programs of the National Institutes of Health (NIH) will apply to grants awarded under this RFA. Awards under this RFA to foreign institutions will be made only for research of very unusual merit, need, and promise, and in accordance with PHS policy governing such awards. MECHANISM OF SUPPORT This RFA will use the NIH individual research project grant (R01) mechanism of support. Investigators without prior R29 or R01 support are encouraged to apply for this RFA and to identify their status in a cover letter. Specific R01 application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, applicant institutions, reviewers, and Institute staff. While multidisciplinary approaches are encouraged, it is not the intent of this announcement to solicit applications for large studies encompassing a variety of individual subprojects, i.e., program projects. If collaborative arrangements through subcontracts with other institutions are planned, consult the program staff listed under INQUIRIES. For this RFA, funds must be requested in $25,000 direct cost modules and a maximum of eight modules ($200,000 direct costs) per year may be requested. A feature of the modular grant concept is that no escalation is provided for future years, and all anticipated expenses for all years of the project must be included within the number of modules being requested. Only limited budgetary information will be required and any budget adjustments made by the Initial Review Group will be in modules of $25,000. Instructions for completing the Biographical Sketch have also been modified. In addition, Other Support information and the application Checklist page are not required as part of the initial application. If there is a possibility for an award, necessary budget, Other Support and Checklist information will be requested by NHLBI staff following the initial review. The APPLICATION PROCEDURES section of this RFA provides specific details of modifications to standard PHS 398 application kit instructions. Applicants are expected to furnish their own estimates of time required to achieve the objectives of the proposed research project. Since a variety of approaches would represent valid responses to this RFA, it is anticipated that there will be a range of costs among individual grants awarded. Up to five years of support may be requested on R01 applications. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. It is anticipated that support for this program will begin in September, 1997. Administrative adjustments in project period and/or amount may be required at the time of the award. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. The National Institute of Allergy and Infectious Diseases (NIAID) also has interest in host factors that influence susceptibility to infectious diseases. Therefore, applications that are of mutual interest are likely to be given a secondary assignment to NIAID in accordance with the NIH referral guidelines. A program announcement "Innovative Drug Discovery Research in AIDS Opportunistic Infections" (PA-96-068), NIH Guide Vol. 25, No. 26, August 2, 1996, covers areas of research complementary to this RFA and may be of interest to some investigators. FUNDS AVAILABLE It is anticipated that for fiscal year 1997, approximately $2,000,000 total costs will be available for the first year of support for this initiative. Award of grants pursuant to this RFA is contingent upon receipt of such funds for this purpose. It is anticipated that approximately eight new grants will be awarded under this program. The specific number to be funded will, however, depend on the merit and scope of the applications received and on the availability of funds. Direct costs will be awarded in modules of $25,000, less any overlap or other necessary administrative adjustments. Indirect costs will be awarded based on the negotiated rates. Applicants may request up to five years of support. RESEARCH OBJECTIVES Background Pulmonary disease associated with HIV infection continues to be a major cause of morbidity and mortality. Our knowledge of the host factors and mechanisms involved in the defense against pulmonary disease, including Mycobacterium tuberculosis (Mtb), Pneumocystis carinii, endemic fungal pathogens, and pulmonary Kaposi's sarcoma, in the HIV-infected host is still limited. The contribution of host factors appears to be important but is poorly understood at present. To gain a better understanding of this area of science we need more information on the host factors that restrict growth of microbes and the establishment of Kaposi's sarcoma in the lungs of healthy individuals, as well as how these factors function in those that are immunodeficient. For example, susceptibility to tuberculosis (TB) is greatly increased among HIV-infected patients (approximately five percent a year compared to 10 percent over a lifetime) but variable, suggesting that factors other than low CD4 counts must be involved. The factors that prevent individuals dually infected with HIV and Mtb from developing active TB need to be determined. Host genetic factors, e.g., the natural resistance associated macrophage protein (Nramp) gene, acquired immune responses, and environmental factors (e.g., nutrition, smoking) appear to play a role. Genetic variation as well as acquired changes in immune function may affect many aspects of host defense against pulmonary diseases. Receptors for uptake of Mtb are being identified, e.g., complement receptors, mannose receptors and facilitation of uptake by surfactant protein A (SP-A). A better understanding of these and other "receptors" that microorganisms use for cellular penetration may reveal genetic differences. More information is needed on "receptor" polymorphism, for example, different binding affinities might account for some differences in individual susceptibility. Similarly, genetic differences as well as acquired immune responses may affect the function of certain key cytokines necessary for control of infection. "Knock-out" and other mouse models indicate vital roles for cytokines, e.g., tumor necrosis factor (TNF), gamma interferon (INF), as well as other determinants, including intracellular killing by nitric oxide, in control of Mtb. A genetic factor, the human Nramp has recently been cloned and expressed. What role it may play is unclear. More information is needed about the genetic basis for natural resistance and phenotypic expression of resistance genes in the lung. Better animal models are needed now to understand the complexities of innate and acquired resistance and the mechanisms of latency and reactivation. HIV-infected and other immunosuppressed hosts frequently develop severe lung infections due to infection with fungi. Among the most important fungal agents are the endemic mycoses histoplasmosis, blastomycosis and coccidioidomycosis. An important feature shared by all three is that the inhaled spores cannot be killed by neutrophils. Moreover, prior to establishment of cell mediated immunity these fungi are phagocytized by macrophages and neutrophils and continue to propagate within these cells. Once cell mediated immunity develops in the immunologically competent host, the infection is benign and self limited. However, in hosts with abnormal T-cell mediated immunity, one can expect to see progressive and widely disseminated infection. Thus, all three of these fungi are common opportunistic infections in HIV infected patients. Once these diseases are diagnosed in AIDS patients, survival is poor (from a few days to up to three months), even with treatment. Histoplasmosis has complicated the course of Hodgkin's lymphoma, corticosteroid and immunosuppressive treatment, but with the advent of the HIV pandemic there has been a tremendous increase in the number of patients with disseminated histoplasmosis. Widely disseminated disease occurs in two ways, by reactivation of previously dormant infection in patients who appear to have recovered from an earlier H. capsulatum infection, and as a result of progressive disseminated primary infections. Blastomycosis also complicates HIV infection in a manner analogous to histoplasmosis. However, the number of cases is small and there is more frequent involvement of the central nervous system. Coccidioidomycosis/HIV co-infection is becoming increasingly more common. Most patients present with a rapidly progressive pulmonary infection, frequently with a rapidly evolving reticulonodular infiltrate seen on chest radiograph. Treatment of endemic fungal infections in HIV-infected patients is difficult and often requires large doses of amphotericin-B and other drugs that have toxic side effects. Large numbers of people are infected with fungi in the endemic areas. For example, in Indianapolis the prevalence of clinical disease due to H. capsulatum in the HIV-infected population is approximately 27 percent. Management of severe fungal infections affecting HIV-infected populations in areas endemic for fungi continues to be a difficult clinical challenge. Treatment of fungal infections might be improved if genetic factors, which appear to be important determinants of disseminated disease, were better understood. Dissemination probably occurs before immunity is established. What allows it to occur, or prevents it from happening? An obstacle to learning about these fungal diseases is the danger of working with the pathogens that cause them. These fungi, in their filamentous from, represent class II (B. Dermatitidis) and class II (H. Capsulatum, C. Immitis) biohazards, and therefore pose a risk of laboratory acquired infection through inhalation of aerosols. Pneumocystis carinii is an opportunistic organism that frequently complicates the course of HIV disease. In contrast to the other infectious agents discussed, P. carinii, although it is cleared from the lung by macrophages, is an extracellular pathogen which primarily parasitizes Type I alveolar epithelial cells. The organisms sit on the surface of the Type I alveolar epithelial cells, but never get inside. However, the cells are damaged and slough off. Recent studies have focused on mechanisms of attachment of P. carinii to the surface of the Type I cells and the role of SP-A. Thus far, no studies suggest mechanisms by which P. carinii organisms "parasitize" the Type I alveolar epithelial cells. What the organism gains from living in the alveolar space on the surface of these particular cells is not known. Nor is it known, how this affects the life cycle of these organisms. Resistance of seemingly healthy/normal individuals to mycobacterial and endemic fungal infections of the lung is extremely variable. In most infected persons, infections are mild and limited to the lung, but in a few, disease is severe and sometimes disseminated. Why does disease disseminate in so few individuals? It is likely that host factors, especially genetic factors may play an important role. Similarly, what host factors prevent the establishment of P. Carinii infection in the lungs of healthy hosts and some immunosupressed hosts? Host resistance to mycobacteria, fungi and leishmania in mice all appear to be influenced by genetic factors. In mice infected with leishmania, those with a strong Th1 response are resistant to disease, but this can be reversed by giving the animals anti-INF antibody. The reverse experiments can be done too, i.e., animals lacking a Th1 response can be made resistant to disease by giving INF . The leishmania locus may be the same as the Nramp locus. Interestingly, patients with HIV and TB also lack the Th1 response, as opposed to having an increased Th2 response. A better understanding of host resistance and susceptibility to all these diseases could lead to better therapeutic strategies. Expression of diseases in the lung, such as TB, Pneumocystis and Kaposi's sarcoma may be directly affected by unique viral factors. For example, HIV Tat protein was found to amplify the activity of tumor necrosis factor (TNF) and in T cells the HIV Tat appears to alter the redox state by suppressing the activity of manganese superoxide dismutase. Thus, the T-lymphocytes might be modulated by this HIV-specific protein in a way that reduces their functional capacity and facilitates expression of disease. Objectives and Scope The objective of this program is to understand at the molecular and cellular level how host factors, both genetic and acquired, affect susceptibility to a variety of HIV-associated infections and Kaposi's sarcoma. Research applicable to this initiative could include studies of normal, nonspecific and specific host defenses to provide a frame of reference for what occurs in the immunodeficient state; and to understand why under "normal" conditions it is difficult to produce Kaposi's and severe pulmonary infections (in humans and animals). Investigations might address how HIV infection and other immunosupressed states affect innate resistance to pulmonary Kaposi's sarcoma as well as mycobacterial, fungal and other pulmonary infections. Among the disciplines and expertise that may be appropriate for this research program are microbiology, mycology, bacteriology, virology, molecular biology, cell biology, immunology, molecular immunology, infectious diseases, pathology, pulmonary medicine, and pediatrics. Examples of areas of research (in HIV-infected, other immunodeficient or "normal" human subjects, suitable animal models or in vitro models) that might be included under this RFA are as follows: o investigate genetic factors that influence susceptibility to severe infections of the lung with endemic fungal pathogens and to dissemination of disease; o elucidate genetic or other factors within the host lung cells that prevent or permit latency and/or reactivation of Mtb; o Identify specific "receptors" and determine the molecular mechanisms that allow pathogens to gain entry to cells in the lung;. o elucidate host factors that influence establishment and progression of Kaposi's sarcoma in the lung. These are examples only. Investigators should not feel limited to the subjects mentioned above and are encouraged to submit other topics pertinent to the objectives of the RFA. It is anticipated that human, animal, and in vitro studies would be appropriate. Investigators are encouraged to apply findings from in vitro work to in vivo studies when this is feasible. The initiative is relevant to black and Hispanic minority populations who are disproportionately affected by HIV in comparison to the total population. SPECIAL REQUIREMENTS This initiative will not address mechanisms of activation of HIV in the lung. This was the subject of another RFA, "Regulation of HIV Activation in the Lung." However, studies involving the influence of HIV in either a latent or active state, pro viral components, dysfunctional virus, or viral products, on the progression of HIV-associated lung diseases would be appropriate. Upon initiation of the program, the NHLBI will sponsor periodic meetings to encourage exchange of information among investigators who participate in this program. In the budget of the grant application, travel funds for a one day meeting each year, most likely to be held in Bethesda, Maryland, should be included in the modules. Applicants should also include a statement in their applications indicating their willingness to participate in these meetings. Applications that propose descriptive studies and do not contain hypothesis driven studies directed at understanding the mechanisms that influence host susceptibility to HIV-associated lung diseases will not be acceptable. Applications that focus on these mechanisms at the molecular level are of particular interest. Although studies in human subjects are strongly encouraged, large clinical studies are not within the scope of this RFA. Applicants who propose to test hypotheses in animal or in vitro models must provide a strong rationale for relevance to the human host. This program will not support studies directed at development of animal models alone, therefore the models must be applied to the study of how host factors affect susceptibility to HIV-associated pulmonary disease. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should follow the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research", which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators 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. LETTER OF INTENT Prospective applicants are asked to submit, by March 14, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains allows NHLBI staff to estimate the potential review workload and to avoid conflict of interest in the review. Applicants without prior R29 or R01 support are urged to identify themselves in the letter of intent. The letter of intent is to be sent or faxed to: Dr. C. James Scheirer Division of Extramural Affairs National Heart, Lung, and blood Institute 6701 Rockledge Drive, MSC 7924 Bethesda, MD 20892-7924 Telephone: (301) 435-0266 FAX: (301) 480-3541 Email: james_scheirer@nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20898-7910, telephone 301-435-0714, E-mail: asknih@odrockm1.od.nih.gov; and from Melonie Shine at the address listed under INQUIRIES. The RFA label found in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Investigators without prior R29 or R01 support are strongly encouraged to identify their status in a cover letter. This RFA is restricted to R01 grants. All will be awarded as modular grants. The modular grant concept establishes specific modules (increments) in which direct costs may be requested and a maximum level for requested direct cost. Only limited budgetary information is required in the application; a detailed budget need not be provided. Sample budgets and justification page will be provided upon request or following the submission of a letter of intent. BUDGET INSTRUCTIONS The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398 (rev 5/95). It is not required nor will it be accepted at the time of application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget tables on Form page 5 of the PHS 398 (rev. 5/95). Only the requested total direct costs line for each year must be completed based on the number of $25,000 modules being requested. Applicants may not request a change in the amount of each module. A maximum of EIGHT modules ($200,000 direct costs) per year may be requested and each applicant may request up to FIVE years of support for this RFA. Direct cost budgets will remain constant throughout the life of the project (i.e., the same number of modules requested for all budget periods). Any necessary escalation should be considered when determining the number of modules to be requested. However, in the event that the number of modules requested must change in any future year due to the nature of the research proposed, appropriate justification must be provided. Total Direct Costs for the Entire Proposed Project Period should be shown in the box provided. o BUDGET JUSTIFICATION - Budget justifications should be provided under "Justifications" on Form Page 5 of the PHS 398. - List the names, role on the project and proposed percent effort for all project personnel (salaried or unsalaried)and provide a narrative justification for each person based on his/her role on the project. - Identify all consultants by name and organizational affiliation and describe the services to be performed. - Provide a general narrative justification for individual categories (equipment, supplies, etc.) required to complete the work proposed. More detailed justifications should be provided for high cost items. Any large one-time purchases, such as large equipment requests, must be accommodated within these limits. o CONSORTIUM/CONTRACTUAL COSTS - If collaborations or subcontracts are involved that require transfer of funds from the grantee to other institutions, it is necessary to establish formal subcontract agreements with each collaborating institution. A letter of intent from each collaborating institution should be submitted with the application. Only the percentage of the consortium/contractual TOTAL COSTS (direct and indirect) relative to the total DIRECT COSTS of the overall project needs to be stated at this time. The following example should be used to indicate the percentage cost of the consortium, "The consortium agreement represents 27% of overall $175,000 direct costs requested in the first year.". A budget justification for the consortium should be provided as described in the "Budget Justification" section above (no Form Page 5 required for the consortium). Please indicate whether the consortium will be in place for the entire project period and identify any future year changes in the percentage relative to the parent grant. If there is a possibility for an award, the applicant will be requested to identify actual direct and indirect costs for all years of the consortium. Please note that total subcontract costs need not be calculated in $25,000 modules. However, when subcontract funds are added to the parent grant budget, the total direct cost amount must be included in the number of $25,000 modules requested. o BIOGRAPHICAL SKETCH - A biographical sketch is required for all key personnel, following the modified instructions below. Do not exceed the two-page limit for each person. - Complete the educational block at the top of the form page; - List current position(s) and those previous positions directly relevant to the application; - List selected peer-reviewed publications directly relevant to the proposed project, with full citation; - The applicant has the option to provide information on research projects completed and/or research grants participated in during the last five years that are relevant to the proposed project. o OTHER SUPPORT - Do not complete the "Other Support" pages (Form Page 7). Selected other support information relevant to the proposed research may be included in the Biographical Sketch as indicated above. Complete Other Support information will be requested by NHLBI staff if there is a possibility for an award. o CHECKLIST - No "Checklist" page is required as part of the initial application. A completed Checklist will be requested by NHLBI staff if there is a possibility for an award. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applications not conforming to these guidelines will be considered unresponsive to this RFA and will be returned without further review. Submit a signed, typewritten original of the application and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express courier service) At the time of submission, two additional copies of the application must be sent to Dr. C. James Scheirer, at the listed under INQUIRIES. Applications must be received by April 30, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. o If an application is determined to be unresponsive to the RFA, the principal investigator will be notified and may request that the application be returned or sent to DRG where it will be processed in the next available cycle as a regular grant application. o A sample budget is available upon request from Mr. Raymond Zimmerman at the number listed under INQUIRIES. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NHLBI, in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a review in which only those applications deemed to have the highest scientific merit of the applications under review (usually two to three times the number of applications that the NHLBI anticipates being able to fund under the program) will be discussed, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory Council. The personnel category will be reviewed for appropriate staffing based on the requested percent effort. The direct costs budget request will be reviewed for consistency with the proposed methods and specific aims. Any budgetary adjustments recommended by the reviewers will be in $25,000 modules. The duration of support will be reviewed to determine if it is appropriate to ensure successful completion of the requested scope of the project. 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 adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program priority. The anticipated date of award is September 29, 1997. INQUIRIES Inquiries concerning this RFA are encouraged. Potential applicants may request copy of sample budget pages as previously stated. The opportunity to clarify any issues or questions from potential applicants is welcome. Particularly, applicants who have not had prior R29 or R01 support are urged to contact the NHLBI. Direct requests for the sample budget pages to: Melonie Shine Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10018, MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: melonie_shine@nih.gov Direct inquiries regarding programmatic issues to: Hannah H. Peavy, M.D. Division of Lung Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 10018, MSC 7952 Bethesda, MD 20892-7952 Telephone: (301) 435-0222 FAX: (301) 480-3557 Email: hannah_peavy@nih.gov Direct inquiries regarding fiscal matters to: Raymond L. Zimmerman Grants Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Suite 7154, MSC 7926 Bethesda, MD 20892-7926 Telephone: (301) 435-0171 FAX: (301) 480-3310 Email: raymond_zimmerman@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.838. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, 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 a 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. From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-012 - V26(01) 01/10/97 Date: 16 Jan 1997 14:10:18 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 410 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bm90a$gkv@net.bio.net> NNTP-Posting-Host: net.bio.net IMPROVED TECHNOLOGIES FOR PRODUCTION OF FULL-LENGTH HUMAN cDNA NIH GUIDE, Volume 26, Number 1, January 10, 1997 RFA: CA-97-012 P.T. 34; K.W. 1002008, 0760053, 0755035 National Cancer Institute Letter of Intent Receipt Date: February 15, 1997 Application Receipt Date: April 29, 1997 PURPOSE The Technology Development Branch of the Cancer Diagnosis Program, Division of Cancer Diagnosis, Treatment, and Centers at the National Cancer Institute (NCI) invites applications for the development and application of innovative technologies for efficiently generating representational, full length cDNA libraries. Full length cDNAs are those clones that contain a copy of the entire mRNA sequence from which they were derived. Representational libraries are those libraries that contain at least one cDNA for every mRNA species present in the starting tissue. Ultimately, this new technology must provide an efficient, cost-effective method for generating full length, representational cDNA libraries from tissue samples. These libraries will provide access to full length clones for those investigators who have previously identified important partial clones in other libraries. In addition the clones from these libraries will provide new gene sequences which will aid in gene discovery and gene function assessment. Therefore, investigators may propose to develop novel technologies initially on a small scale or they may propose to further develop existing efficient technologies into a high-throughput system. The most desirable technologies will be those that are easily exportable to the research community. In order to encourage applications proposing innovative, high-risk projects, exploratory/experimental research grant (R21s) will be used to support meritorious applications. A total of $2.5 million will be available to support approximately 10 awards. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA) Improved Technologies for Production of Full-Length Human cDNA, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit, and nonprofit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications may be from single institutions but collaborative studies are also encouraged. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for this program will be through the National Institutes of Health (NIH) exploratory/experimental research grant (R21) awards. The total project period for applications submitted in response to the present RFA may not exceed three years. The anticipated award date is September 1, 1997. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. Except as otherwise noted in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publications No. (OASH) 94-50,000, revised April 1, 1994. FUNDS AVAILABLE It is anticipated that a total of $2.5 million (total costs) will be available. Approximately 10 awards are expected to be made from the total pool of applications received. The number of awards made will be contingent upon the quality of applications received and the availability of funds. RESEARCH OBJECTIVES Background The rapid increase in our understanding of tumor biology coupled with the technology and data emerging from the human genome project offer the opportunity for a change in the way cancer research is done. It is becoming clear that cancer is not a single disease but many, and that cancers arise from the gradual accumulation of genetic changes in single cells. It is not clear which changes and how many changes are required to cause an invasive cancer. Defining which genes are involved in the initiation and progression of cancer remains a challenge. An immediate benefit from the human genome project has been the large scale generation and sequencing of over 500,000 human expressed sequence tags (EST). EST are valuable in that they allow a rapid preliminary identification of a large number of expressed genes. They are limited in that the clones themselves often represent only partial genes. Often the partial clone is not adequate to assess the gene's biological function. In addition, few of the libraries currently being sequenced are from tumor or other cancer related tissues. Cost-effective, representational full length cDNA libraries are necessary to facilitate the identification of genes involved in cancer initiation and progression. The NCI has established the Cancer Genome Anatomy Project (CGAP) to capitalize on the technology and data emerging from the human genome project and refocus it in the direction of cancer research. CGAP has two main foci: first, the development of a complete index of genes expressed in tumors and second, the development of new technologies that will facilitate high throughput analysis of molecular alterations in cancer cells and dissemination of these technologies to basic and clinical researchers. The initial effort of CGAP is to generate and sequence cDNA libraries from four targeted tumor sites: breast, prostate, colon and lung. Though these libraries will be useful in identifying genes involved in cancer, they rely on current technology which does not guarantee complete representation or full length clones. Current technology allows the production of representational libraries of partial genes or production of more limited libraries of full length clones, which are generally enriched for shorter genes. In addition, technology exists to create normalized (reduced redundancy) cDNA libraries. However, it is not currently possible to efficiently generate representational libraries of full length cDNAs. In order to derive the maximum benefit from libraries currently being developed and to find expressed genes not present in the initial libraries, new technologies for generating full length representational cDNA libraries are necessary. Objectives This RFA is intended to support the development and/or the implementation of technologies that generate representational libraries of full length cDNAs from tissues that will contribute to the understanding of cancer at the molecular level. Investigators may propose to create novel technologies or adapt existing technologies for the generation of representational libraries of full length cDNA clones. They may also propose feasibility studies designed to generate libraries from appropriate tissues using the developed technologies. Preferred technologies will be those that are efficient (including, but not limited to, normalization techniques), scalable for high-throughput and easily transferred to other cancer researchers. A primary goal of CGAP is the compilation of a complete index of all genes expressed in tumors. In order to understand the significance of individual genes or gene expression levels, it will be necessary to have libraries from cancerous and nonneoplastic tissue from the same organs for comparison. Therefore, investigators may propose to generate individual libraries or to generate libraries that are enriched for genes differentially expressed from appropriate tissues after successful completion of the technology development phase of the project. Appropriate tissues are those that will provide information about the initiation and/or progression of cancers, including but not limited to tumors of different stages, tumor vs. nonneoplastic tissue, etc. In all cases, approaches must be described for demonstrating that the clones in the libraries encode the entire sequence of the mRNA from which they were derived and contain a representative sample of the original mRNA population of the selected tissue. In addition, the NCI is interested in stimulating the development of innovative technologies that may be supported by limited preliminary data. In order to judge the feasibility of the proposed studies, it is necessary to establish criteria for scientific progress. Therefore, in their applications, investigators must propose specific, quantifiable milestones which can be used to measure the progress of the studies. Although the details are left to the investigator, the milestones proposed must consist of clear, well defined criteria for measuring progress. They must be appropriate for the proposed studies and as specific as possible. Investigators should also propose a clear time line for successfully completing the proposed milestones. 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 sub-populations 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. LETTER OF INTENT Due to the specialized nature of this program, it is strongly recommended that prospective applicants contact NCI staff to discuss research objectives. Prospective applicants are asked to submit, by February 15, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Jennifer Couch, Ph.D. Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 513, MSC 7388 Bethesda, MD 20892-7388 Telephone: (301) 496-1591 FAX: (301) 402-1037 Email: couchj@dcbdcep.nci.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research; from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, e-mail: ASKNIH@odrockm1.od.nih.gov and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it might not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, SUITE 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) To expedite the review process, at the time of submission, send two additional copies of the application to: MS. TOBY FRIEDBERG REFERRAL OFFICER NATIONAL CANCER INSTITUTE 6130 EXECUTIVE BOULEVARD, ROOM 636A, MSC 7405 BETHESDA, MD 20892-7405 ROCKVILLE, MD 20852 (for overnight/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Applications must be received by April 29, 1997. If an application is not received by this date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantially revised application, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness by the NCI program staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications at the next review cycle. Applications proposing the use of currently available technologies for the generation of cDNA libraries form tumor tissues will not be responsive to this RFA. Applications that fail to include the description of appropriate mileposts will also not be responsive. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and will be assigned a priority score. All applicants will receive a summary statement consisting of the reviewer's written comments. Summary statements for competitive applications will also contain a summary of the review committee's discussion. The second level of review will be provided by the National Cancer Advisory Board. Review criteria for RFAs are essentially the same as those for unsolicited research grant applications and include the following: o scientific and technical merit of research plans and novelty 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 appropriateness of the proposed budget and duration in relation to the proposed research o availability of the resources necessary to perform the research The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. Additional considerations specific to this RFA include the following: o the degree to which the technology meets the ultimate objective of creating representational libraries of full length cDNA clones from appropriate tissues o efficiency and cost-effectiveness of the proposed technology. o the appropriateness of the time-frame and mile posts proposed by the investigator to evaluate the progress of the technology development and/or implementation AWARD CRITERIA The anticipated date of award is September 30, 1997. The following criteria will be considered in making funding decisions: the quality of the proposed project as determined by peer review; the responsiveness of the proposed project to the goals of this RFA; and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants are welcome. Direct inquiries regarding programmatic issues to: Jennifer Couch, Ph.D. Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 513, MSC 7388 Bethesda, MD 20892-7388 Telephone: (301) 496-1591 FAX: (301) 402-1037 Email: couchj@dcbdcep.nci.nih.gov Direct inquiries regarding fiscal matters to: Ms. Theresa Mercogliano Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 243 FAX: (301) 496-8601 Email: MERCOGLT@GAB.NCI.NIH.GOV AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.394, Cancer Detection and Diagnostic Research. 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 and Part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS)strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. 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. From owner-sci-resources@net.bio.net Wed Jan 15 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA OD-97-004 - V26(01) 01/10/97 Date: 16 Jan 1997 14:09:58 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 520 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5bm8vm$gj9@net.bio.net> NNTP-Posting-Host: net.bio.net EDUCATIONAL WORKSHOPS IN INTERDISCIPLINARY RESEARCH NIH GUIDE, Volume 26, Number 1, January 10, 1997 RFA: OD-97-004 P.T. 42; K.W. 0710030, 0414015, 0417000, 0502000 Office of Behavioral and Social Sciences Research National Center for Research Resources National Institute of Nursing Research National Institute on Drug Abuse National Institute of Dental Research Letter of Intent Receipt Date: March 14, 1997 Application Receipt Date: April 25, 1997 PURPOSE The Office of Behavioral and Social Sciences Research (OBSSR), the National Center for Research Resources (NCRR), the National Institute of Nursing Research (NINR), the National Institute on Drug Abuse (NIDA), and the National Institute of Dental Research (NIDR) invite applications for grants to develop and conduct short-term (1-2 weeks) educational workshops in interdisciplinary research aimed at social, behavioral, and biomedical researchers in the formative stages of their careers. The NIH sponsoring organizations are jointly issuing this Request for Applications (RFA) to foster cross-disciplinary communication and research collaborations. Grant applications are requested that propose, as their educational objective, the integration of health research across various levels of analysis. These levels can include environmental, social, individual, organ system, cellular, and molecular levels. Special emphasis is placed on facilitating (1) the integration of different fields of social and behavioral sciences research and/or (2) the integration of these areas with the more biological analyses. The short-term goal of this initiative is to encourage social/behavioral and biomedical scientists at an early stage of their careers to learn each other~s methods, procedures, and/or theoretical perspectives. The long-term goal of this RFA is to enable researchers to develop cross-disciplinary collaborations and to submit quality grant applications with interdisciplinary approaches. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000" a PHS-led national activity for setting priority areas. This RFA, Educational Workshops in Interdisciplinary Research, is related to all priority areas. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY Applications may be submitted by any domestic for-profit or non- profit organization, public or private, such as universities, colleges, hospitals, laboratories, units of State and local governments, or eligible agencies of the Federal government that are engaged in health-related education or research. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health education project grant (R25). Applications submitted in response to this RFA cannot be used to support existing ongoing training. These Interdisciplinary Workshop Grants are intended to support only educational activities that promote interdisciplinary research and may not be used for support of clinical training or clinically- oriented continuing education programs in the health professions. Up to $100,000 direct costs may be requested for up to one year of support. Indirect costs, other than those awarded to State or local government agencies, will be reimbursed at eight percent of total allowable direct costs. State and local government agencies will receive reimbursement at their full indirect cost rate. Because the nature and scope of the workshop proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. This RFA is a one-time solicitation. However, it may be reissued depending on availability of funds and NIH programmatic goals. Allowable costs Costs must be consistent with PHS Policy and be reasonable, allowable, and well documented and justified for the proposed educational workshop. Specifically, funds may be requested for: Personnel costs - salary and fringe benefits may be requested for the time spent by faculty members on the design and implementation of the workshop. Salaries requested may not exceed the levels commensurate with the institution~s policy for similar positions. Administrative and clerical salary costs associated with the workshop may be direct charges to the grant only when specifically identified and justified as reflecting significantly greater effort than the level of such services routinely provided by academic departments. Requests for consultant costs, equipment, supplies, necessary travel, and other project related expenses must be justified as specifically required by the workshop proposed and not duplicate items generally available at the institution for educational programs. Participants in the workshop may receive only per diem living (necessary lodging and meals) and domestic or foreign travel expenses associated with attendance at the interdisciplinary workshop(s). Since this is a short-term educational workshop, citizenship requirements do not apply to the participants. Unallowable costs: Tuition costs are not allowed under this RFA nor can the participants receive any payment for attendance, nor be charged a fee for attendance at the interdisciplinary workshop(s). Funds from this RFA may not be used to supplement stipends or provide other individual compensation to trainees supported by PHS training grants. FUNDS AVAILABLE It is estimated that for fiscal year 1997, $972,000 total funds (direct and indirect costs) will be available. It is anticipated that approximately nine to twelve one-year, non-renewable education project awards will be made; however, the exact number will depend on the quality of applications and the availability of funds. RESEARCH OBJECTIVES The objective of this RFA is to support educational workshops that foster the development of cross-disciplinary communication and research collaboration. Health is affected by physiologic and genetic factors, as well as behavioral, social, and environmental factors. The interactions of these factors can be studied at different levels of analysis, ranging from the molecular level through the system and individual to the social structural level. The clearest evidence of biopsychosocial interactions concerns the effects of behavioral and social factors on physiologic functioning. For example, research shows that smoking, diet, exercise, chronic and acute stress, anger, social support, and socioeconomic status all have profound effects on the central nervous, cardiovascular, endocrine, and immune systems. Such interactions make it imperative to more fully integrate behavioral with social science research, and both behavioral and social science research with more traditional biomedical areas of health research. This RFA is being coordinated under the auspices of the Office of Behavioral and Social Sciences Research (OBSSR) of the National Institutes of Health. OBSSR provides leadership and direction in increasing the scope and support of research on the role of behavior and social processes in the etiology and the prevention of disease and the promotion of health. One of OBSSR's strategies to promote this cross-cutting interdisciplinary research is to support short- term training workshops for social, behavioral, and biomedical scientists to learn each others methods and procedures at an early stage in their career. Several NIH Institutes and Centers have joined with OBSSR to support this project, and each seeks to encourage research related to its own mission. The NINR is interested in training programs that foster improved cross- disciplinary collaboration. This RFA is directly related to the NINR's emphasis on multi-disciplinary research spanning the basic and clinical sciences. The NIDA is interested in integrative and multi- disciplinary approaches to drug addiction. This RFA is responsive to NIDA's emphasis on the development of training experiences in the area of drug abuse and addiction. The NIDR is interested in multidisciplinary oral and craniofacial research, including basic studies using oral or craniofacial tissues to elucidate mechanisms underlying a wide array of disease processes. This RFA is responsive to NIDR's emphasis on the development of multidisciplinary research and training. These Education Grants support short-term (1-2 weeks) workshops for promising predoctoral students, post-doctoral scholars, and/or junior faculty, that are designed to give them a broad understanding of fields outside their own in order to foster improved cross- disciplinary communication and collaboration. For example, a workshop may focus on educating behavioral researchers in the conceptualization and measurement of social, environmental, or economic variables; or the training of social or behavioral researchers in research methods employed in immunology, neuroscience, genetics, or in the areas of heart, lung, and blood diseases, or drug addiction. Biomedical researchers might be educated in sociobehavioral theory and research methods, such as techniques for measuring and manipulating behavior in animal models of disease; social and behavioral epidemiological approaches; cognitive and behavior therapy techniques; economic analyses; and methods in cognitive neuroscience, behavioral genetics, or immuno-modulation. Other examples for educational workshop topics include, but are not limited to, end of life issues, clinical outcome research, and/or vulnerable populations. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which has been published in the Federal Register of March 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources of from the program staff or contact the person listed below. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 14, 1997, a letter of intent that includes a descriptive title of the proposed workshop, the name, address, and the telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to the program staff listed below. Gerdi Weidner, Ph.D. Office of Behavioral and Social Sciences Research National Institutes of Health Building 1, Room 326 - MSC 0183 Bethesda, MD 20892-0183 Telephone: (301) 435-3718 FAX: (301) 402-1150 Email: gerdi_weidner@nih.gov APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95). 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 301/435-0714, email: ASKNIH@odrockm1.od.nih.gov. Applications are to be prepared according to the instructions provided on pages 5-20 except for the following regarding C. Specific Instructions: C. Specific Instructions: 1. Application Face Page: Item 2. Check the box marked ~YES~ and type the number and title of this Request for Applications. Item 6. Enter 093097 through 092998. The proposed period of support may not exceed one year. Items 7 and 8. The direct cost request may not exceed $100,000. Indirect costs are limited to eight percent of total allowable direct costs, except applicants that are State and local governments may request full indirect cost reimbursement. 5. Budget for Entire Proposed Period of Support (Form Page 5-EE) - not applicable; do not complete. 9. Research Plan Follow the instructions for items a. (Specific Aims) and b. (Background and Significance). Item c. (Preliminary Studies/Progress Report) should be retitled "Preliminary Data and Activities" and included, if applicable. This section should contain information on steps that have led to the proposed workshop. Item d. (Research Design and Methods) should be retitled "Educational Workshop Plan". This section should provide sufficient detail to allow reviewers to evaluate the proposed workshop according to the specific review criteria for this RFA. Information in this section should be organized under the following subheadings: 1) Proposed Workshop - provide detail on the design and content of the proposed workshop (e.g., time frame, courses, curricula, specific activities) and the resource requirements (e.g., description of the facilities, laboratories, participating departments, computer services, and any other resources to be used in the conduct of the workshop). 2) Workshop Participants - provide detail about the targeted participants; include a description of plans for recruiting, as participants, individuals from under-represented racial/ethnic groups. 3) Workshop Faculty/Staff - describe the characteristics and responsibilities of the faculty; provide evidence that participating faculty and preceptors are actively engaged in research or other scholarly activities related to the proposed workshop. 4) Principal Investigator - describe arrangements for administration of the workshop; provide evidence that the Principal Investigator is actively engaged in interdisciplinary research and/or teaching in an area involving the social and behavioral sciences (investigators with a biomedical background should provide evidence of collaborations with social and/or behavioral scientists); provide evidence that the Principal Investigator can organize and administer the workshop program. 5) Institutional commitment - provide evidence of institutional commitment and support for the proposed workshop, e.g. commitment of facilities, staff, etc . Items (e) through (i) should be completed following the standard 398 instructions. Applications not following the above instructions will be returned to the applicant without review. The RFA label available in the PHS 398 kit must be affixed to the bottom of the face page of the original copy of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face of the application form and the YES box must be marked. Submit a signed, typewritten original of the application and three signed, exact photocopies, in one package, to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At time of submission, two additional copies of the application must also be sent under separate cover to: Gerdi Weidner, Ph.D. Office of Behavioral and Social Sciences Research National Institutes of Health Building One, Room 326 - MSC 0183 Bethesda, MD 20892 Applications must be received by the firm deadline date of April 25, 1997. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications previously reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG, and for responsiveness by NIH program staff. Incomplete applications will be returned to the applicant without further consideration. In addition, if program staff find that an application is not responsive to the RFA, it will be returned to the applicant without review. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by DRG in accordance with 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 National Advisory Council of the relevant NIH Institute or Center. The review committee will assess the educational, scientific, and technical merit of any application accepted by the DRG and deemed to be responsive to the RFA by NIH program staff. These applications should be of high quality and responsive to the stated purpose of this RFA. Grant applications submitted in response to this RFA should be characterized by innovation, scholarship, and responsiveness to the goals of the RFA. To ensure that these objectives are met, applications will be evaluated by the following criteria: o likelihood of the proposed workshop to foster interdisciplinary health research and cross-cutting collaborations; o overall quality of the proposed educational workshop as related to its capability to achieve its short-term and long-terms goals; o appropriateness of the workshop curriculum and design for providing interdisciplinary research education; o educational environment and the quality of the facilities; o recruitment and selection plans for participants; o quality of the workshop faculty in terms of past records of achievement in at least one area of the proposed training and in terms of current engagement in research related to the proposed workshop; o quality of the workshop leadership, both in terms of past records of achievement in the area of the proposed training (i.e., interdisciplinary research), and qualifications to implement the proposed workshop; o institutional commitment. In addition, appropriateness of the budget and the duration of the support needed to achieve the stated goals and objectives will be evaluated. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program priorities, and the availability of funds. Schedule Letter of Intent Receipt Date: March 14, 1997 Application Receipt Date: April 25, 1997 Initial Review: June/July 1997 Advisory Council Review: September 1997 Earliest Start Date: September 30, 1997 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Gerdi Weidner, Ph.D. Office of Behavioral and Social Sciences Research National Institutes of Health Building 1, Room 326 - MSC 0183 Bethesda, MD 20892-0183 Telephone: (301) 435-3718 FAX: (301) 402-1150 Email: gerdi_weidner@nih.gov Jaylan S. Turkkan, Ph.D. Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-20 Rockville, MD 20857 Telephone: (301) 443-1263 FAX: (301) 594-6043 Email: jaylan@nih.gov J. Taylor Harden, Ph.D, R.N. Division of Extramural Activities National Institute of Nursing Research 45 Center Drive, Room 3AN-12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5976 FAX: (301) 480-8260 Email: THARDEN@ep.ninr.nih.gov Patricia Bryant, Ph.D. Division of Extramural Research National Institute of Dental Research 45 Center Drive, Room 4AN24E Bethesda, MD 20892 Telephone: (301) 594-2095 FAX: (301) 480-8318 Email: BRYANTP@DE45.NIDR.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Jenelle D. Wiggins Office of Grants and Contracts Management National Center for Research Resources 6705 Rockledge Drive, Room 6086 - MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 480-3777 Email: JenelleW@ep.ncrr.nih.gov Jeff Carow Grants Management Office Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN-32 Bethesda, MD 20892-6301 Telephone: (301) 594-6869 FAX: (301) 480-8256 Email: JCAROW@ep.ninr.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.389 (NCRR), 93.316 (NINR), 93.279 (NIDA) and 93.121 (NIDR). Awards are made under authorization of the Public Health Service Act, Titles III, Part A, and IV of the Public Health Service Act, and are administered under PHS grants policies and Federal Regulations 42 CFR Part 52, and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive order 12372, or Health Systems Agency Review. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse 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. From owner-sci-resources@net.bio.net Mon Jan 20 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 18 January 1997 Date: 21 Jan 1997 09:14:52 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 114 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5c2tic$6c7@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending January 18, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: INT 97-2 Report Memorandum #96-26 1996 SURVEY OF RESEARCH AND DEVELOPMENT IN JAPAN -- R&D Expenditure Turning Upward Again -- File size (bytes): 6072 STIS Filename: int972.txt Document Type: Press Release Title: PR972-Capital Punishment Decisions Hinge on Jurors Who May Not Understand Their Task File size (bytes): 4106 STIS Filename: pr972.txt Title: PR973-SCIENTISTS PROBE CONNECTIONS BETWEEN COAST-TO-COAST AND ATLANTIC OCEAN WINTER STORMS Better Weather Forecasts, Understanding of Climate to Result File size (bytes): 4213 STIS Filename: pr973.txt Document Type: Program Guideline Title: NSF 97-41--Cise Educational Innovation Program File size (bytes): 17701 STIS Filename: nsf9741.txt Document Type: Recruit Title: Director, Budget Division File size (bytes): 8058 STIS Filename: vep972.txt Title: Biological Science Admin (Asst Program Director or Assoc Program File size (bytes): 11589 STIS Filename: vex976.txt Title: Senior Program Assistant File size (bytes): 7285 STIS Filename: vgs9727.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 114197 STIS Filename: phnalpha.txt Also available: phnalpha.dlm Title: NSF Organization Telephone Directory File size (bytes): 129637 STIS Filename: phnorg.txt Document Type: Program Guideline Title: NSF 97-20 Elementary, Secondary, and Informal Education File size (bytes): 243990 STIS Filename: nsf9720.txt Title: NSF 97-20 Elementary, Secondary, and Informal Education File size (bytes): 243990 STIS Filename: nsf9720.txt Title: NSF 97-39--NSF/DOE Partnership in Basic Plasma Science and Engineering File size (bytes): 11733 STIS Filename: nsf9739.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve nsf9739.txt, the text of your message should be as follows: get nsf9739.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve nsf9739.txt, you would enter: ftp> get nsf9739.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Tue Jan 21 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: BIOSCI/bionet miniFAQ & Fundraiser Date: 21 Jan 1997 21:41:44 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 240 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <199701201000.CAA25502@net.bio.net> NNTP-Posting-Host: net.bio.net (LAST REVISION: 30-JUL-95) This BIOSCI "miniFAQ" is designed to answer the questions that come up the *most frequently*. The main BIOSCI FAQ (Frequently Asked Questions) is accessible on the World Wide Web at URL http://www.bio.net/. If you can not find an answer to your question in this or other documentation, the BIOSCI technical support staff answers e-mail queries sent to biosci-help@net.bio.net We can only answer questions about the use of the newsgroups and mailing lists. We unfortunately do not have the staff to do Internet information searches or answer scientific questions. Please post those to the appropriate BIOSCI/bionet newsgroups. Contents: -------- 0) BIOSCI NEEDS YOUR SUPPORT!! 1) Using the WWW to access the BIOSCI/bionet newsgroups. 2) What to do about "spams," i.e., junk mail, ads, etc. 3) Examples of subscribing and unsubscribing to the mailing lists. 4) The BIOSCI user address and research interest directory. 0) BIOSCI NEEDS YOUR SUPPORT!! ------------------------------ BIOSCI's government funding has been expended, and we are now operating solely from advertising revenue that we have raised from our Web site at http://www.bio.net/. We need just a few minutes of your time to help us serve you. You can do two important things which will take very little time for you individually and will immensely help us continue to help you. First, please use our WWW system at http://www.bio.net/ to access the archives. You can post or reply to messages via your Web browser as described in item #1 below. Your usage helps attract sponsors. If you contact any of our sponsors, please be sure to thank them for supporting BIOSCI. It is critical for them to get this feedback if they are to continue their sponsorship for the long term. Second, if you work for a company or organization that provides products or services of interest to the biology community, please pass this message on to your marketing or marketing communications department or other appropriate group. Please ask them to help support BIOSCI by sponsoring our Web site and explain the uses and benefits of the system to the biology community. If they are interested, they can then contact us for further information at our tech support address, biosci-help@net.bio.net. 1) Using the WWW to access the BIOSCI/bionet newsgroups. -------------------------------------------------------- As of 10 December 1995, all BIOSCI/bionet full newsgroups are accessible through the World Wide Web (WWW) at URL http://www.bio.net. One can read and reply publicly or privately to both recent postings and archived messages through one's Web browser if it is configured properly to send e-mail. Each newsgroup is equipped with its own WAIS index. The main BIOSCI home page also has access to the BIO-JOURNALS Table of Contents database WAIS index and the BIOSCI user address database described in another item further below. 2) What to do about "spams," i.e., junk mail, ads, etc. ------------------------------------------------------- BIOSCI is a set of parallel USENET newsgroups (the "bionet" groups), mailing lists, and a hypermail archive at URL http://www.bio.net/. The same postings are distributed on all media (except for a small number of mailing-list-only groups at net.bio.net). Unfortunately it is becoming a despicable practice on the Internet (by a few people out to make a fast buck) to do automated mass postings to thousands of newsgroups and mailing lists. These attempts to grab free advertising are refered to as "spams" in the usual, somewhat boneheaded, net terminology. USENET is more susceptible to this practice, and many spams originate on the USENET groups and then are passed on to the mailing lists. However, spammers also get lists of mailing addresses and hit these too, so neither medium is immune. What should you do personally if you get junk mail? --------------------------------------------------- Just delete it and move on without reading it further. Filing a protest is becoming increasingly useless because spammers are often disguising the addresses where the messages are sent from. Unless you really understand Internet mail systems, your attempt at protest by sending replies to the message will often end up being sent to the address of an innocent person that the spammer is victimizing. What can BIOSCI/bionet do to protect its newsgroups? ---------------------------------------------------- The only solution currently available is to moderate the newsgroup. If this newsgroup is already moderated, then you are in good shape. Moderation protects the USENET distribution from about 95% of the spams that are being sent to date and protects the mailing lists completely. Moderation means, however, that someone has to take the time to review each message before it goes out. We have set up software here that simply allows the moderator to forward to an address at net.bio.net messages that (s)he wishes to have distributed. This takes no more time than that needed to read the message and pass it on, say about 1 min. per message. Most newsgroups currently have a discussion leader who is responsible for their newsgroup. The discussions leaders and their e-mail addresses are listed in the BIOSCI Information Sheet which is available on the Web at http://www.bio.net/. If a newsgroup is being hit with too many junk postings, please contact the discussion leader for that group and see if there is interest in moderating the group. Please do not assume that by simply posting a complaint to the newsgroup itself, anyone on the BIOSCI staff will act on your complaint. With close to 100 newsgroups to run, the BIOSCI staff has to rely on the discussion leaders of each newsgroup to report problems directly to us at biosci-help@net.bio.net. We will moderate any of our newsgroups if the discussion leader tells us that the readership of the group wishes to do so and if a moderator is willing to do the work. For most BIOSCI/bionet groups, this entails only a few minutes of work each day. Moderating a newsgroup will resolve probably 95% of the junk postings on the USENET distribution. Unfortunately there are easy ways for determined spammers to override the moderation mechanism on USENET, but we can protect our e-mail subscribers from unwanted postings if the newsgroup is moderated. You can also access our newsgroups over the WWW at URL http://www.bio.net. While this Web interface will not stop spammers from trying to post to the groups, this will give you yet another way, besides using USENET news, to keep the junk out of your personal mail files. For those of you with local USENET news systems, the Web interface will also give you faster access to new newsgroups and recent postings. 3) Examples of subscribing and unsubscribing to the mailing lists. ------------------------------------------------------------------ PLEASE NOTE: The BIOSCI management does NOT act on subscription/unsubscription requests that are posted improperly to the newsgroups and mailing lists. People who do this only bother everyone on the lists to no avail. Please be sure to follow the proper procedures below. Gory details are in the BIOSCI Information sheets on the Web at http://www.bio.net. Below we give an example utilizing the METHODS-AND-REAGENTS list at both of our two BIOSCI sites: Users in the Americas and Pacific Rim countries who use the BIOSCI ------------------------------------------------------------------ node at computer net.bio.net: ---------------------------- A) Determine the "listname" which is the <=8 character mail address ^^^^^^^^^^^^^ for the group. These can be found in the BIOSCI Info. Sheet. For the METHODS-AND-REAGENTS group the mailing address is methods@net.bio.net. The listname is the portion of the address to the left of the @ sign, i.e., "methods". The listname is used with the "subscribe" and "unsubscribe" commands illustrated below. B) Mail all commands in the body of a mail message addressed to biosci-server@net.bio.net. Do NOT send commands to the newsgroup posting addresses! Leave the Subject: line blank, any text on it will be ignored. C) In the body of your message put one or more of the following commands with an "end" command on the last line, e.g., subscribe methods unsubscribe methods end Do NOT put your e-mail address or other text on these lines. The server only allows you to cancel your subscription if the address on your mail header matches the address on our mailing list. Please ask for help at biosci-help@net.bio.net if your address has changed, e.g., if you know you are on the list but the server tells you that you are not a member. Users in Europe, Africa, and Central Asia who use the BIOSCI node at -------------------------------------------------------------------- computer daresbury.ac.uk (also known as dl.ac.uk): ------------------------------------------------- To subscribe and unsubscribe to/from the BIOSCI lists, you need to specify the full USENET newsgroup name with "bionet-news." prepended. The USENET newsgroup names are listed in the BIOSCI Information sheet on the Web at http://www.bio.net/. For the METHODS-AND-REAGENTS list the USENET newsgroup name is bionet.molbio.methds-reagnts, thus the appropriate commands are sub bionet-news.bionet.molbio.methds-reagnts unsub bionet-news.bionet.molbio.methds-reagnts These commands are included in a message addressed to mxt@dl.ac.uk, NOT to the newsgroup mailing addresses. As usual, include the text in the body of the message as text on the Subject: line is ignored. To unsubscribe from all the lists at the UK node, use unsub bionet-news Please note that if the address in the list is different than the one in your mail message header, you will not be able to unsubscribe by this method. If you have problems, please mail biosci@daresbury.ac.uk. 4) The BIOSCI user address and research interest directory. ----------------------------------------------------------- Please take this opportunity to add your name, address, and research interest information to the BIOSCI User Address Database if you have not already done so. You can fill out the address form directly through our Web page at URL http://www.bio.net/adrform.html. The address database is reindexed nightly for WWW access (the URL is http://www.bio.net/). If you are not directly on the Internet but can reach it by e-mail, please use our waismail server to access the user directory. waismail use is described above. You can also request a user address form by e-mail from biosci-help@net.bio.net. Please check your database entry from time-to-time to see if your address information is still up-to-date. Because of our limited personnel resources, we ask that you resubmit a *complete* form to revise your entry; we only replace complete entries and do not have resources to edit old forms. Sincerely, Dave Kristofferson BIOSCI/bionet Manager biosci-help@net.bio.net From owner-sci-resources@net.bio.net Mon Jan 27 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - PA-97-025 - V26(02) 01/17/97 Date: 27 Jan 1997 16:24:34 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 563 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5cjh02$dmi@net.bio.net> NNTP-Posting-Host: net.bio.net RESEARCH ON MUSCULOSKELETAL FITNESS AND SPORTS MEDICINE NIH GUIDE, Volume 26, Number 2, January 17, 1997 PA NUMBER: PA-97-025 P.T. 34; K.W. 0705050, 0710020, 0715027, 0715136, 0745030, 0765020, 0785205 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute of Nursing Research PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the National Institute of Nursing Research (NINR) invite investigator-initiated research grant applications to study a broad range of basic and clinical topics related to musculoskeletal fitness, exercise physiology and sports medicine. The National Center for Medical Rehabilitation Research of the National Institute of Child Health and Human Development (NCMRR/NICHD) encourages applications for both basic and clinical studies of musculoskeletal fitness and exercise physiology of persons with physical disabilities. 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), Research on Musculoskeletal Fitness and Sports Medicine, is related to the priority area of physical activity and fitness. 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, D.C. 20402-9325 (telephone 202-783-3238). The PA is related to issues in the 1996 Surgeon General's Report on "Physical Activity and Health" (Stock No. 017-023-00196-5). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal government. Foreign institutions are eligible to apply for regular research project grants (R01). MECHANISM OF SUPPORT Under this program announcement, the NIAMS and NICHD will support investigator-initiated research project grants (R01), First Independent Research Support and Transition (FIRST) (R29) awards, small grants (R03), program projects (P01), career development grants (K01, K02, K08), and Investigator-Initiated Interactive Research Project Grants (IRPG.) The IRPG is described in PA-96-001, published in the NIH GUIDE, Vol. 24, No. 35, October 6, 1995. The Principal Investigator and participating investigators will plan, direct, and perform the research. Applicants for program project grants are requested to contact the NIAMS representative listed below as early as possible in the planning stages. The NINR will support individual research project grants (R01 and R29.) RESEARCH OBJECTIVES Background Physical activity builds strong muscles and bones and improves flexibility and balance at all stages of life. Musculoskeletal fitness and physical activity protects individuals against over- exertion or strains, preventing consequences including low back pain, muscle tears, bone fractures, tendon ruptures, and other disorders. Musculoskeletal fitness delays the onset of frailty as people age and protects against disorders like osteoporosis. Additionally, fitness lowers risk for obesity, cardiovascular disease, and other chronic illnesses. There is not a strong scientific research basis for understanding how the body integrates molecular mechanisms to coordinate fitness in muscle, bone, tendon, and ligament. Recent surveys included in the Surgeon General's Report on Physical Fitness show that approximately one-fourth of U.S. adults are physically inactive. It is important to promote exercise for inactive people that improves fitness yet does not seem onerous. While we know much of the vigorous regimens used by body-builders and long distance runners, we have little experimental evidence of how shorter, more focussed patterns of exercise can effectively build muscle and bone strength. We have even less information about the physiological bases for appropriate musculoskeletal rehabilitation interventions and the exercise needs of persons with physical disabilities. There is a health problem also for those who engage in extremely strenuous exercise or sports regimens. More than 30 million young Americans participate in organized competitive sports, and one of every two adult Americans exercises regularly. This has lead to an increase in activity-related injuries, which is substantial, extending beyond sports into its impact on the workforce. It has been estimated that 17 million persons in this country sustain significant injury from sports or recreational participation yearly. One-third of the 15 million joggers will sustain an injury that involves the musculoskeletal system. During 1995 football injuries resulted in 390,000 emergency room visits, while skiing resulted in 330,000 visits. Evidently understanding the causes, prevention, and treatment of athletic and recreational injury is a major health issue. Many currently recommended sports and exercise practices are not based on strong scientific evidence. The empirical designs of many protective devices are not founded in fundamental biomechanical studies. Additionally, there is a strong scientific understanding of the normal physiology of muscle, but not a large base of research into muscle metabolism, hypertrophy and injury during exercise, strength training, and disuse. Feedback mechanisms by which the muscle senses and communicates its mechanical requirements are unknown. Similarly, bone strength increases following muscle strength, but the molecular couplers of the two actions have not been characterized. Research efforts have yielded many improvements in training athletes, preventing injuries and treating patients. Technological advances have improved the practice of sports medicine. Further improvements in the use of new technologies and information systems are likely to improve methods of preventing, diagnosing, and treating sports injuries. Surveillance and treatment can be improved with the development of standard and normative measures of musculoskeletal fitness. Improved knowledge can be gained through increased basic science research related to sports medicine and in applying the information gained to practical problems in this field. NIAMS promotes increased basic science research related to exercise and sports medicine to gain improved knowledge about normative measures of musculoskeletal fitness. An aim is to develop appropriate exercise patterns to build muscle and bone strength for men and women who are relatively inactive as well as world class athletes. Exercise patterns should be appropriate throughout the life spectrum, and not limited by performance level or the presence of physical or psychological challenges. Objectives and Scope This solicitation is intended to stimulate research that provides an expanded foundation of basic science knowledge related to musculoskeletal fitness and sports medicine. Additionally, it is intended to encourage use of the best available scientific information in important clinical and applied aspects related to exercise, training, prevention, treatment and rehabilitation. This program announcement includes a wide range of basic and applied research on various aspects of musculoskeletal fitness. Applicants are encouraged to submit high scientific quality research projects in any area related to the broad objectives of this program announcement. No order or priority of areas of interest has been established. General Considerations - A large research effort is required to establish a firm scientific foundation for a basic and applied program in musculoskeletal fitness and sports medicine. Several aspects of musculoskeletal fitness and injury require increased knowledge: athletic performance during competition; training and prevention; treatment, and rehabilitation. Research in these areas may involve various types of individuals, such as young children, adolescents, mature adults, aged, professional athletes, men or women. Because the appropriate fitness information may be different for each type of individual as they experience different possible phases of musculoskeletal fitness or injury, research should be carefully directed to the results applied to a particular combination. This includes differences between endurance and resistance exercise regimens. Examples of investigations of interest to the NIAMS include but are not limited to research on: 1. Muscle Physiology and Metabolism - Studies on changes in metabolic, structural and contractile proteins following patterns of disuse, and endurance and resistance strength training. Explore the interrelationships and molecular steps between mechanical stimuli and biochemical changes. Determine how molecular responses differ depending on demands of endurance and resistance training. Relate altered use of chemical fuel to training status of muscle, performance responses, and health prevention. Investigate changes in fiber recruitment patterns and motor unit control. Develop a mechanistic understanding of the growth and maturation of muscle as related to use and specialization. 2. Muscle membranes - Studies on changes on both external and internal muscle membranes (e.g. sarcoplasmic reticulum) in response to patterns of use. This includes studies on receptors for circulating factors (hormones), complexes involved in excitation-contraction coupling, and surfaces involved in the transfer of force, such as the extracellular matrix and the myotendinous junction. 3. Exercise Pathophysiology - Investigations of the damage and healing of tissue from factors such as mechanical or thermal overloading or systemic biochemical changes. Study molecular bases of fatigue in contractile, metabolic, and excitation-contraction systems. Explore the role of heat shock proteins in protecting tissue during bouts of mild or extreme hyperthermia. 4. Injury Mechanisms - Determine the mechanical forces and biochemical environments that weaken and injure muscle, bone, and connective tissues. Establish the forces and force distributions within joint structures and tissues, both during normal function and during trauma. Explore influence of age and gender on structural aspects that might influence location and severity of specific types of injury. Establish the conditions present during competitive sports and recreational activities that may lead to damaged tissue. Compare overuse versus traumatic injuries. Investigate the role of neuromuscular control and fatigue in injuries. 5. Role of Exercise in the Prevention and Treatment of Bone and Joint Diseases - Explore the interrelationships and molecular steps between mechanical stimuli and biochemical changes. Determine how molecular responses differ depending on demands of endurance and resistance training. Determine relationship between exercise patterns and degenerative joint diseases, such as osteoarthritis. Establish possible mechanisms for prevention of bone diseases including osteoporosis. 6. Healing - Improved general understanding of the natural healing process for muscle, bones, and connective tissue. Determine what interventions are most successful in enhancing healing and under what conditions should these therapies are applied. Establish the role of cytokines in inflammation and healing. Investigate healing from localized tissue damage as a preliminary step in strengthening and/or enlarging muscle and other connective tissue. 7. Circulation - Improved understanding of changes in circulation within the musculoskeletal system in response to patterns of use. This announcement encourages studies on the mechanisms involved in altered micro-vasculature and extra-vascular circulation in muscle, bone, and joints. Investigators should explore differences due to endurance and resistance training. 8. Fitness and Wellness - Determine how molecular responses differ depending on demands of endurance and resistance training. Provide improved understanding of how musculoskeletal activity leads to general body fitness. This would include homeostasis of the immune, endocrine, and neuroendocrine systems. Explore how exercise patterns affect different components of the immune system, determining molecular mediators. 9. Fitness and Nutrition - Explore how regular exercise effects body need and use of nutrients. Study how patterns of musculoskeletal activity differentially alter body allocation of metabolites and energy supplies, exploring intercellular and inter tissue communications. Study the role of nutrition and dietary supplements in improving performance and reducing fatigue. 10. Clinical Studies - Provide improved repair and replacement of injured muscle, connective tissues and joints. Characterize improvements in materials and methods for transplantation, augmentation, and replacement of ligaments and tendons. Common sports injuries and symptoms include ligaments of the knee (such as anterior cruciate ligaments and medial collateral ligaments), patellar pain, and rotator cuff syndrome. Study surgical and non-surgical treatments, including rehabilitation modalities. 11. Junctional Assessment and Gait Analysis - Establish simple, quantitative measures of joint motion and forces that may be uniformly applied at most research and clinical sites. Document the use of such evaluations for improved pre-injury screening and post-injury surveillance. 12. Epidemiology - Define the incidence and natural history of injury in competitive sports and recreational activities. Establish risk factors for incurring injuries and for the progression of an injury to a more serious medical problem. Determine relationships between sequential chronic and acute injuries. 13. Prevention and Training - Develop improved protective sporting equipment and training methods, especially for high risk competitive and recreational activities. Determine the short and long range benefits and side-effects from using anabolic steroids and other chemical enhancers of performance. Establish more completely the interrelations between neuromuscular and connective tissue response to training. Applications of interest to the NCMRR/NICHD should be related to issues of musculoskeletal fitness, exercise physiology, and sports medicine relevant to people with physical disabilities. Especially encouraged are basic and clinical studies that will lead to the development of rehabilitation interventions to enhance physical fitness, prevent further disability through overuse injuries, and lead to greater independence and physical functioning. NINR is interested in related research on musculoskeletal fitness and physical activity across the age continuum, especially studies on: exercise and primary prevention, body fitness and wellness, and clinical studies that test interventions that influence patient health outcomes and reduce costs and demand for care. 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 sub- populations 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, 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 Submit applications on the grant application form PHS 398 (rev. 5/95); applications will be accepted at the standard receipt deadlines shown. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714; email: ASKNIH@odrockm1.od.nih.gov. The number (PA-97-025) and title (RESEARCH ON MUSCULOSKELETAL FITNESS AND SPORTS MEDICINE) must be typed in Section 2 on the face page of the application. The completed original application 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/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be reviewed in accordance with the usual NIH peer review procedures for research grants (Study Section). Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. Review Criteria for Research Grants o Scientific, technical, or medical significance and originality of the 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. Review Criteria for Career Awards Candidate o Quality of the candidate's academic and clinical record, o Potential to develop as an independent researcher; o Commitment to a research career; and o Likelihood that the plan will contribute substantially to the achievement of scientific independence. Career Development Plan o Likelihood that the career development plan will contribute substantially to the scientific development of the candidate; o Appropriateness of the content, the phasing, and the proposed duration of the career development plan for achieving scientific independence; o Consistency of the career development plan with the candidate's career goals; and o Quality of the proposed training in responsible conduct of research. Research Plan Reviewers recognize that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. Although it is understood that K08 applications do not require the level of detail necessary in regular research grant proposals, a fundamentally sound research plan must be provided. In general, less detail is expected with regard to research planned for the later years of the award, but the application should outline the general goals for these years. o Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills as described in the career development plan; o Scientific and technical merit of the research question, design and methodology; o Relevance of the proposed research to the candidate's career objectives; and o Adequacy of the plan's attention to gender and minority issues. Mentor o Appropriateness of mentor's research qualifications in the area of this application; o Quality and extent of mentor's proposed role in providing guidance and advice to the candidate; o Previous experience in fostering the development of researchers; and o History of research productivity and support. Environment and Institutional Commitment o Applicant institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program; o Adequacy of research facilities and training opportunities; o Quality and relevance of the environment for scientific and professional development of the candidate; and o Applicant institution's commitment to an appropriate balance of research and clinical responsibilities. AWARD CRITERIA Applications recommended by a National Advisory Council will be considered for funding on the basis of overall scientific and technical merit, program needs and balance, and availability of funds. INQUIRIES For further information about programs in the National Institute of Arthritis and Musculoskeletal and Skin Diseases, investigators are encouraged to contact: Richard W. Lymn, Ph.D. Muscle Biology and Musculoskeletal Fitness Program Director National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building Room 5AS 49E Bethesda, Maryland 20892-6500 Telephone: (301)594-5128 FAX: (301)480-4543 e-mail: lymnr@ep.niams.nih.gov Investigators concerned with orthopedic studies are encouraged to contact: James S. Panagis, M.D. Orthopedics Program Director National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building Room 5AS 37K Bethesda, Maryland 20892-6500 Telephone: (301)594-5055 FAX: (301)480-4543 e-mail: panagisj@ep.niams.nih.gov For information about support by the National Center for Rehabilitation Research, contact: Danuta Krotoski, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 61E, Room 2A-03 Bethesda, MD 20893-7510 Telephone: (301) 402-2242 Email: krotoskd@hd01.nichd.nih.gov For information concerning research interests of the National Institute of Nursing Research, contact: J. Taylor Harden, PhD, RN Division of Extramural Programs National Institute of Nursing Research Building 45, Room 3AN-12 45 Center Drive, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5976 FAX: (301) 480-8260 Email: THARDEN@ep.ninr.nih.gov Direct inquiries regarding fiscal matters to: Ms. Sally A. Nichols National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5 AS 49F Bethesda, MD 20892-6500 Telephone: (301) 594-3535 FAX: (301) 480-5450 Email: nicholss@ep.niams.nih.gov Ms. Mary Ellen Colvin National Institute of Child Health and Human Development Building 61E, Room 8A-17 Bethesda, MD 20892-7510 Telephone: (301) 496-1303 E-mail: colvinm@hd01.nichd.nih.gov Jeff Carow Grants and Contracts Management Branch National Institute of Nursing Research Building 45, Room 3AN-32 Bethesda, MD 20892-6301 Telephone: (301) 594-5074 FAX: (301) 480-8256 Email: JCAROW@ep.ninr.nih.gov AUTHORITY AND REGULATIONS These programs are described in the Catalog of Federal Domestic Assistance No. 93.846, (Arthritis, Musculoskeletal and Skin Diseases Research), No. 93.929 (Medical Rehabilitation Research,) and No. 93.361 (Nursing Research). Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 410, 78th Congress, as amended, 42 USC 241) and administered under PHS grants policies and Federal regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant 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. From owner-sci-resources@net.bio.net Mon Jan 27 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NSF - Summary of new documents on STIS, 25 January 1997 Date: 27 Jan 1997 16:28:10 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 109 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5cjh6q$dun@net.bio.net> NNTP-Posting-Host: net.bio.net This message contains a summary of the documents added to the NSF STIS system for the week ending January 25, 1997. Reference material concerning STIS follows the summary. ------------------------------------------------------------------------ ** NEW DOCUMENTS ON STIS ** Document Type: International Document Title: INT 97-4 - Special Scientific Report #97-01 File size (bytes): 6029 STIS Filename: int974.txt Title: INT 97-5 - TRM #97-1 "Quick Summary" of JFY 1997 Government Budget File size (bytes): 7260 STIS Filename: int975.txt Document Type: Program Guideline Title: NSF 97-33 -- RURAL SYSTEMIC INITIATIVES IN SCIENCE, MATHEMATICS AND TECHNOLOGY EDUCATION File size (bytes): 39692 STIS Filename: nsf9733.txt Title: NSF 97-42 -- Postdoctoral Fellowships in Science, Mathematics, Engineering and Technology Education (PFSMETE) File size (bytes): 33644 STIS Filename: nsf9742.txt Title: NSF 97-49 - Ecology and Oceanography of Harmful Algal Blooms - An Inter-Agency Research Program File size (bytes): 31258 STIS Filename: nsf9749.txt Document Type: Recruit Title: Office Automation Clerk File size (bytes): 7504 STIS Filename: vgs9716a.txt ------------------------------------------------------------------------ ** UPDATES TO EXISTING STIS DOCUMENTS ** Document Type: Committees Title: NSF Advisory Committee Meetings File size (bytes): 11443 STIS Filename: cmmtg.txt Document Type: International Document Title: Int97-3 - Special Scientific Report No9616 File size (bytes): 18262 STIS Filename: int9616.txt Document Type: Phone Book Title: NSF Alphabetical Telephone Directory File size (bytes): 114269 STIS Filename: phnalpha.txt Title: NSF Organization Directory File size (bytes): 126907 STIS Filename: phnorg.txt Document Type: Recruit Title: Senior Program Assistant File size (bytes): 7285 STIS Filename: vgs9727.txt ------------------------------------------------------------------------ ** FOR YOUR REFERENCE (updated 8/23/96) ** ------------------------------------------------------------------------ HOW TO OBTAIN DOCUMENTS We are currently migrating to a completely Web-based information dissemination system. Please visit our Web site at the following URL: http://www.nsf.gov/ The above files refer to the STIS system, which is being replaced. If you are familiar with STIS, you can use the information above to retrieve these files: Documents via E-mail: Send a message to stisserve@nsf.gov Use the "STIS Filename" shown above in the "get" command. For example, to retrieve vgs9727.txt, the text of your message should be as follows: get vgs9727.txt Anonymous FTP: FTP to stis.nsf.gov. Use the "STIS Filename" shown above to retrieve a file. For example, to retrieve vgs9727.txt, you would enter: ftp> get vgs9727.txt If you want a *printed* copy of a document: Send your name and postal mailing address, and the document title and number to "pubs@nsf.gov". If you have problems with the above procedures: Send a message to "stis@nsf.gov". From owner-sci-resources@net.bio.net Mon Jan 27 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA DK-97-007 - V26(02) 01/17/97 Date: 27 Jan 1997 16:22:02 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 506 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5cjgra$d96@net.bio.net> NNTP-Posting-Host: net.bio.net EXPLORATORY GRANTS IN CHRONIC RENAL FAILURE IN CHILDREN NIH GUIDE, Volume 26, Number 2, January 17, 1997 RFA: DK-97-007 P.T. 34, AA; K.W. 0715133 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: March 18, 1997 Application Receipt Date: April 18, 1997 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the need to enhance research activities in Pediatric Nephrology. The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the NIDDK invites Exploratory Research Project Grant Applications (R21s) to encourage and facilitate studies designed to develop and/or apply new promising experimental tools to the understanding of the pathophysiology and pathogenesis of events resulting in chronic renal failure and its complications, in children. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications Exploratory Grants in Chronic Renal Failure in Children, is related to the priority area of chronic disabling diseases and food safety. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public or private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) Exploratory/Developmental Research Project Grant (R21) Award. The total requested project period for applications submitted in response to this RFA may not exceed two years. The requested budgets may not exceed $50,000 (Direct Costs) per 12-month budget period. The anticipated award date will be September 30, 1997. This RFA is a one-time solicitation. If the NIDDK determines that there is a sufficient continuing program need, a request for applications will be announced. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. FUNDS AVAILABLE A total of $500,000 in total costs for each of two years will be committed by the NIDDK to fund applications submitted in response to this RFA. It is anticipated that approximately five to seven awards will be made. However, this funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NIDDK, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The primary objective of this solicitation is to invite Exploratory Research Project Grant Applications from members of the diverse pediatric research community with research interest, technology, tools and strategies that could be brought to bear on problems relevant to chronic renal failure in children. In order to meet these objectives, this solicitation is put forward to encourage and facilitate the development of exploratory research protocols focused on the pathophysiology and pathogenesis of chronic renal failure in children. The final aim is directed towards the enhanced understanding of the underlying mechanisms leading to chronic renal failure and its complications in children in a combined effort to reduce or eliminate its causes, control disease progression and provide pediatric patients with new and optimal management and interventions. Background Chronic renal disease (CRD) and renal failure in pediatric patients represent a significant problem; the clinical care and attendant services required to manage these patients are the most difficult, time consuming and frustrating endeavors for patients, their families, and treating pediatric nephrologists. Furthermore, when renal replacement therapies are needed, these must be individually tailored to each patient and continuously adapted to meet the special requirements of the growing and developing patient. Progressive renal disease occurs in all age groups resulting from varying underlying causes, recognized as distinct according to the different age-categories involved. Congenital structural malformations, including vesicoureteral reflux, obstruction, hypoplasia and dysplasia, represent the principal underlying causes of end-stage renal disease (ESRD) particularly in the very young child. Added to these, older children also develop chronic renal failure (CRF) resulting from glomerular and tubulointerstitial disease, immune complex disease, hemolytic uremic syndrome, IgA nephropathy, focal segmental sclerosis, hereditary nephropathies, etc. The majority of these disease entities remain mechanistically mysterious. Diabetic nephropathy, so frequently underlying ESRD in the adult population, does not result in CRF in childhood. Nevertheless, most patients with diabetes who develop ESRD in their 20s and 30s, are those whose diabetes presented during childhood or early adolescence. In children, as in adults, renal disease progression occurs even when the primary renal insult has been corrected, treated, or become inactive. Adaptive mechanisms may play an important role in the ongoing process. The similar histologic appearance of chronic renal diseases, which is independent of the initial lesion, represents further evidence that such progressive pathway may be common to all. Regardless of where in the kidney the insult occurs, the structural hallmark of progressive failure is the development of scar tissue, through fibrinogenesis. The biologic mediators of scar formation in the glomerulus have been actively examined and some of the biological mediators which regulate these processes are currently under active investigation. Research continues to focus on growth factors and cytokines which mediate mesangial cell proliferation and the production of extracellular matrix. Treatment of experimental models with agents that block these growth factors have provided new insights into disease pathogenesis and future management. During the past decade, dramatic developments have unfolded in the field of molecular genetics and allied disciplines, allowing for the application of powerful tools and strategies to the investigation of kidney diseases. These same tools need to be more forcefully applied to research focused on renal diseases affecting children. A few selected examples are listed to highlight research progress and opportunities. Included, among many others, are the following recent accomplishments: o Specific mutations have been demonstrated in the collagen COL4A5 gene in patients with Alport's Syndrome. o Molecular alterations associated with the alpha 3 chain of type IV collagen are implicated in the development of Goodpasture's Syndrome, in humans. o The Wilm's tumor suppressor gene WT1, has been identified. Germline WT1 mutations predispose to Wilm's tumor and are often associated with urogenital anomalies. o The cystinuria gene has been mapped to chromosome 2, subregion 2p21, and three distinct phenotypes for cystinuria have been described. The identification of four novel mutations shall serve to complement the measurements of cystine excretion in the selection of patients with high risk of nephrolithiasis, for anticipatory prevention. o The congenital nephrotic syndrome (CNS) locus has been assigned to chromosome 19q12-q13.1 on the basis of linkage analysis in Finnish families; the linkage of the CNS locus to the same chromosomal region was also confirmed in non-Finnish CNS families. CNS is inherited as an autosomal recessive trait and it has been postulated that the primary defect could be a structural and functional defect in the glomerular basement membrane. o In IgA nephropathy, a deletion (D) polymorphism of a fragment of a 287-bp fragment of intron 16 of the angiotensin converting enzyme (ACE) gene, has been recently found to have a significant association with progressive deterioration of renal function. The association of hypertension and mild initial reduction of renal function, as risk factors for progression, suggest that the presence of the DD ACE genotype may shift IgAN from mild to severe, and nephropathy from subclinical to overt. It is suggested that the presence of proteinuria may act as a risk factor for disease progression and renal failure, conceivable because proteinuria and progression share the same genetic risk factor, namely the D polymorphism of the ACE gene. o Concerning complications resulting from CRF, in recent years, the treatment option of recombinant human GH (rhGH) has been successful in stimulating growth in children with various degrees of CRF. Despite this treatment, growth retardation remains one of the major obstacles to successful rehabilitation of children and adolescents with CRF. The pathogenesis of uremic growth failure is only partially understood and it is viewed as resulting from several interrelated processes, all contributing to growth impairment in the uremic child. Recombinant human growth factor (rhIGF-I) has been used in combination with rhGH, and has shown a synergistic effect, improving total nitrogen retention in calorically deprived subjects and stimulating linear growth in children with GH receptor defects. This growth factor may offer promise in the treatment of selective growth disorders and protein catabolic states. o The Final Report of the Growth Failure in Children with Renal Disease Study has been published. The data confirmed that once glomerular filtration rate (GFR) falls to less than 50% of normal, an elevated serum PTH level can be expected; both calcitriol and dihydrotachysterol were found to be equally potent in suppressing PTH elevation. Despite research progress and the evidence of the level of productivity and opportunities, many fundamental aspects of the pathogenesis and pathophysiology of the underlying conditions as well as the adaptation to CRF are incompletely understood, unknown, or remain unexplored in pediatrics and require immediate research attention. Therefore, research efforts should continue, and application of the most up to date research tools must be encouraged to be able to make a difference in the overall prevention of renal disease progression as well as in improving the management of the severe complications resulting from CRF in children. This is the focus of the present RFA. Research Goals and Scope It is the intent of this solicitation to invite applications from investigators of the diverse pediatric research community with research interest, technology and specific strategies, who wish to apply their expertise: (i) to elucidate and enhance the current understanding of the pathogenesis and pathophysiology of CRF in children, focusing primarily on events occurring at the cellular and molecular levels; (ii) to identify, characterize, or develop experimental models, faithful to pediatric chronic renal disease, to help in the understanding of the fundamental events leading to renal disease progression and CRF; (iii) to identify interventions that could lead to improvements in the management and outcome of CRF in children. This special program should encourage interdisciplinary collaboration in the basic disciplines to stimulate and facilitate fundamental research work; research applications can also be more narrowly focussed from one predominant discipline. Highly encouraged is the application of promising new experimental tools to the understanding of mechanisms and events leading to CRF and its complications in pediatrics. Examples of pediatric CRF-related topics illustrating areas which would be considered within the intent of this solicitation, and therefore responsive to, this RFA, are listed. These examples are meant, only, to provide a broad direction and should not be considered restrictive: o Studies addressing the biology of kidney development and differentiation with emphasis on molecular events resulting in abnormalities which may lead to the development of CRF. o Investigation of the inflammatory and immunologic processes and the genetic environment factors responsible for glomerular or tubulointerstitial injury perceived as contributors to the development of progressive renal disease and CRF in children. o Identification and characterization of experimental models faithful to pediatric chronic renal disease and CRF. These experimental models should be ideally suited for the detailed evaluation of events occurring at the cellular, molecular or genetic levels, responsible for the ultimate development of CRF. o Elucidation of the pathogenesis and pathophysiology of relevant complications resulting from, or inherent to CRF in children. o Identification and characterization of early markers of renal disease severity in children. o Identification of novel approaches to improve the immediate and long-term outcome of pediatric CRF. It is hoped that a better understanding of events occurring at the cellular and molecular levels with new technologies and investigative approaches, which have already proven extraordinarily useful in genetics, immunology, and allied disciplines, should enhanced the understanding of the pathophysiologic events, should result in a better understanding of the basic mechanisms leading to chronic renal disease, in pediatrics and help in the development of preventive strategies to prevent or improve the management and outcome of CRF in children. Investigators are not limited to the above examples of research focus, and are encouraged to propose other approaches that are appropriate to Exploratory Research Grants, and to the requirements of this RFA. 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 sub-populations 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 may also obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 18, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDDK staff to estimate the potential review workload and avoid possible conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 37-F - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594 8885 FAX: (301) 480 3505 APPLICATION PROCEDURES The research grant application form PHS-398 (rev. 5/95) is be used in applying for these grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, e-mail: ASKNIH@odrockm1.od.nih.gov. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed under item 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist plus three signed, exact photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At time of submission, two additional copies of the application must be sent under separate cover to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS 37-F - MSC 6600 Bethesda, MD 20892-6600 Applications must be received by April 18, 1997. If an application is received after that date, it will be returned to the applicant. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications previously reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIDDK in accordance with NIH peer review procedures. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, DRG staff may contact the applicant to determine whether to return the application to the applicant or submit it for review in competition with unsolicited applications, at the next review cycle. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the national advisory council. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator and the official signing for the applicant organization will be notified. REVIEW CRITERIA o Scientific and technical merit criteria specific to the objectives of the RFA. 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 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. o For applications involving activities that could have an adverse effect upon humans, animals, or the environment, the adequacy of the proposed means for protecting against or minimizing such effects. AWARD CRITERIA The anticipated date of award is September 30, 1997. Award criteria will include the scientific merit of the application as determined by peer review, availability of funds, and programmatic priorities. Schedule Letter of Intent Receipt Date: March 18, 1997 Application Receipt Date: April 18, 1997 Initial Review: July 1997 Second Level Review: September 17-18, 1997 Anticipated Award: September 30, 1997 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Gladys H. Hirschman, M.D. Division of Kidney, Urologic, and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-13 - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: gladys_hirschman@nih.gov Inquiries regarding fiscal matters may be directed to: Aretina D. Perry Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AN-38B - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8862 Email: perrya@ep.niddk.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.849 and 93.848. 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. From owner-sci-resources@net.bio.net Mon Jan 27 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AR-97-001 - V26(02) 01/17/97 Date: 27 Jan 1997 16:21:02 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 471 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5cjgpe$d1f@net.bio.net> NNTP-Posting-Host: net.bio.net SMALL GRANT PROGRAM FOR THE NIAMS NIH GUIDE, Volume 26, Number 2, January 17, 1997 RFA: AR-97-001 P.T. 34; K.W. 0705050, 0715010, 0715185, 0715136, 0715031 National Institute of Arthritis and Musculoskeletal and Skin Diseases Application Receipt Date: March 18, 1997 PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is seeking small grant (R03) applications to stimulate and facilitate the entry of promising new investigators into targeted, high priority areas of NIAMS research. This one-time solicitation will provide support for pilot research that is likely to lead to a subsequent individual research project grant (R01) or a First Independent Research Support and Transition (FIRST) (R29) award application. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Small Grant Program for the NIAMS, is related to the priority area of chronic diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign organizations and institutions are not eligible. Participation in the program by investigators at minority institutions is strongly encouraged. Pilot project grants awarded through this RFA may not be used to support thesis or dissertation research. Current and previous recipients of NIH funding through Research Project Grants (R01) or FIRST (R29) awards are ineligible for this Small Grant Program. Principal Investigators of research subprojects of Research Program Projects (P01) and Centers (P50 and P60) and individuals who have received research support from the National Science Foundation (NSF) or Department of Veterans Affairs (VA) as Principal Investigators are also ineligible. Individuals whose sole previous support has been through developmental (pilot) and feasibility studies may apply. Former and current recipients of NIH Small Research Grants (R03), Academic Research Enhancement Awards (R15), Mentored Clinical Scientist Development Awards (K08), Mentored Research Scientist Development Awards (K01), Shannon Awards (R55), or Individual (F32) or Institutional (T32) National Research Service Award (NRSA) training support are eligible to apply for this Small Grant Program. However, any current support by the F32 or T32 mechanisms must terminate before Small Grant support begins. The work proposed may not overlap significantly with the aims of currently supported projects in which the Principal Investigator has participated during the last five years. (Information on such projects is to be provided as part of the Principal Investigator's Biographical Sketch, as described below under Application Procedures.) Investigators who have questions about eligibility should contact one of the program officials listed under INQUIRIES. MECHANISM OF SUPPORT Applicants may request up to $50,000 (direct costs) per year for up to three years through the small grant (R03) mechanism. It is anticipated that grants would be awarded no later than September 30, 1997. These awards are not renewable. Before completion of the R03, investigators are encouraged to seek continuing support for research through a research project grant (R01) or FIRST (R29) award. Replacement of the Principal Investigator on this award is not permitted. FUNDS AVAILABLE It is estimated that $1.0 million (total costs) will be available to support approximately 12 to 15 awards under this program. Awards are contingent on the availability of appropriated funds and on the receipt of sufficiently meritorious applications meeting the stated eligibility requirements. RESEARCH OBJECTIVES The Small Grant program is designed to facilitate the entry of promising new investigators into high priority areas identified by the NIAMS. Investigators may apply for a small grant to support research in one of the following general areas: Angiogenesis o Endothelial cell dysfunction leading to changes in adhesiveness or blood vessel tone; endothelial cell interactions with inflammatory cells and components of the extracellular matrix; phenotypic changes and biochemical mechanisms of endothelial cell response to inflammatory/immune-mediated tissue injury as they relate to the normal function and diseases of musculoskeletal and connective tissue. o Regulatory factors controlling vascular structure, including molecular events that regulate angiogenesis, endothelial and vascular smooth muscle cell growth and cell death in the context of rheumatic and other connective and musculoskeletal diseases. o Immune responses directed against vascular components o Pathogenesis of vascular manifestations of rheumatic and systemic autoimmune diseases such as lupus, dermatomyositis, scleroderma and rheumatoid arthritis o Studies of vasculitis and vasculopathies in animal models of rheumatic diseases, with emphasis on identification of pathogenetic mechanisms and molecular targets for therapeutic intervention o Therapeutic potential of angiogenesis inhibitors/modulators in rheumatoid arthritis o Therapeutic potential of angiogenesis inhibitors/modulators in psoriasis, immune and non-immune inflammation of the skin (including irritant and allergic contact dermatitis), autoimmune diseases of skin, atopic dermatitis, and wound healing o Inflammatory cell interactions with vasculature in the initiation of immune and non-immune inflammation of the skin and in wound healing o Mechanisms of exercise-induced changes in vascularization of muscle, bone, and connective tissue o Mechanisms of vascularization of new tissue during wound healing in skin and muscle, and during formation of new bone in fracture healing, defect repair, and integration of prosthetic implants Mechanisms of self-recognition in autoimmunity o Molecular pathways and regulatory steps in self-antigen processing o Physicochemical properties of the complex between self-components and antigen-presenting molecules o Design of therapies to prevent abnormal responses to self by affecting antigen processing Bone and Connective Tissue Repair o Formation and repair of tendons and ligaments and their junctions with muscle, cartilage and bone, including characterization of the cell types involved and critical regulatory factors o Cellular and molecular basis of osteolysis occurring at the sites of total joint replacements, including the involvement of wear debris particles, cytokines and specific cellular interactions o Mechanisms of induction of bone and connective tissue growth by mechanical stimuli o Development of allografts and other materials as substitutes for musculoskeletal tissues destroyed by tumors or lost as a consequence of trauma o Mechanisms of bone growth and growth plate organization, especially as relevant to repair of growth plate injuries and treatment modalities such as limb lengthening Stem Cell Biology o Identification, isolation, and culture of stem cells of epidermis and skin appendages, as they relate to skin diseases and wound healing, and to the development of skin-based gene therapy for skin and systemic diseases o Characterization of the mesenchymal progenitors of chondrocytes and osteoblasts, including factors that influence commitment to a particular differentiative pathway, and the ability of the cells to circulate and/or "home" to specific tissues o Characterization of the satellite cells of muscle, including their derivation, location, relative numbers and relation to other stem cell types Other Research o Rheumatic and dermatological manifestations of acquired immunodeficiency syndrome o Pathogenesis of alopecia areata and vitiligo. 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 are 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 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, Email: asknih@odrockm1.od.nih.gov The following instructions are to be used in conjunction with the information accompanying application form PHS-398 (rev. 5/95). They refer only to selected items in the application form. All PHS-398 requirements must be adhered to, with the exception of those items affected by the following instructions; for example, the Research Plan is limited to 10 pages. Applications not conforming to the requested format will be returned to the applicant without review. Please note that some of the information to be omitted from the application at submission may be requested following review if the possibility of funding exists. Face Page o Item 2, Response to Specific Program Announcement: Check the box marked YES. Enter the RFA number (AR-97-001) and title (NIAMS Small Grants Program). o Item 6, Dates of Proposed Period of Support. Up to a total of three years of support may be proposed. o The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Detailed Budget for Initial Budget Period (Page 4) o Do not complete or submit this page. Budget for Entire Proposed Period of Support (Page 5) o Composite Budget Table: Enter total direct costs requested, up to a maximum of $50,000, for each year of support (up to three). o Justification: Provide a narrative justification for each proposed personnel position, including role on the project and proposed level of effort o Provide narrative justification for the additional resources requested for the conduct of the project. Biographical Sketch (Page 6) (Complete for each of the key personnel listed on Form Page 2.) o Research and Professional Experience: List current position(s) and those previous positions directly relevant to the application. o List selected peer-reviewed publications directly relevant to the proposed project, with full citations. o Provide information on research projects completed and/or research grants in which the investigator participated during the last five years which are relevant to the proposed project. For each project or grant listed, provide title, name of Principal Investigator, funding source, and role on project (if not Principal Investigator). Other Support (Page 7) o Do not complete or submit this section. Research Plan o Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 10 pages. Please note that a Progress Report is not needed; no competing continuation applications will be accepted for an R03. Appendix o No appendix material may be submitted. Checklist o The Checklist should not be submitted. Submit a signed original of the application and four signed copies in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC-7710 BETHESDA MD 20892-7710 Bethesda MD 20817 (for express/courier service) At the time of submission, one additional copy of the application must be sent to: Tommy L. Broadwater, Ph.D. Scientific Review Branch National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-25U 45 Center Drive, MSC 6500 Bethesda, MD 20892-6500 In order not to delay review, it is important that applicants comply with this request. Applications must be received by March 18, 1997. If an application is received after that date, it will be returned to the applicant without review. Only one Small Grant application may be submitted by a Principal Investigator. Applicants may not submit an R01 or R29 application for the February 1 or March 1, 1997 receipt date if that application involves significant scientific overlap with a Small Grant application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG. Incomplete applications will be returned to the applicant without further consideration. NIAMS staff will review applications for responsiveness to the research objectives of this RFA and for the eligibility of the Principal Investigator under the requirements stated above. Applications found to be unresponsive or ineligible will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review committee convened by the NIAMS in accordance with the usual NIH peer review procedures. Applications will be evaluated with respect to the following criteria: o Scientific originality and significance of the proposed research o Likelihood of the proposed pilot project leading to the development of an R01/R29 grant application o Ability of the Principal Investigator to direct the proposed research, as demonstrated by the quality of the research plan and the Investigator's training and experience o Documented availability of resources necessary for the research, including any needed to supplement the budget o Adequacy of adherence to guidelines for including gender and minority representation in any study population. AWARD CRITERIA The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Importance of the area to NIAMS research o Availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Susana A. Serrate-Sztein Rheumatic Diseases Natcher Building, Room 5AS-37G Bethesda, MD 20892-6500 Telephone: (301) 594-5032 FAX: (301) 480-4543 Email: SzteinS@ep.niams.nih.gov Dr. Bernadette Tyree Cartilage and Connective Tissue Natcher Building, Room 5AS-37J Bethesda, MD 20892-6500 Telephone: (301) 594-5032 FAX: (301) 480-4543 Email: TyreeB@ep.niams.nih.gov Dr. Richard W. Lymn Muscle Biology Natcher Building, Room 5AS-49E Bethesda, MD 20892-6500 Telephone: (301) 594-5128 FAX: (301) 480-4543 Email: LymnR@ep.niams.nih.gov Dr. James S. Panagis Orthopedics Natcher Building, Room 5AS-37K Bethesda, MD 20892-6500 Telephone: (301) 594-5055 FAX: (301) 480-4543 Email: PanagisJ@ep.niams.nih.gov Dr. Alan N. Moshell Skin Diseases Natcher Building, Room 5AS-25L Bethesda, MD 20892-6500 Telephone: (301) 594-5017 FAX: (301) 480-4543 Email: MoshellA@ep.niams.nih.gov Dr. William J. Sharrock Bone Biology Natcher Building, Room 5AS-37A Bethesda, MD 20892-6500 Telephone: (301) 594-5055 FAX: (301) 480-4543 Email: SharrocW@ep.niams.nih.gov Direct inquiries regarding fiscal matters to: Sally Nichols Grants Management Branch National Institute or Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-49F 45 Center Drive, MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-3535 FAX: (301) 480-5450 Email: NicholsS@ep.niams.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.846. 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 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. From owner-sci-resources@net.bio.net Mon Jan 27 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH Guide, vol. 26, no. 02, pt. 1of1, 17 January 1997 Date: 27 Jan 1997 16:20:42 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 1093 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5cjgoq$d09@net.bio.net> NNTP-Posting-Host: net.bio.net NIH GUIDE - Vol. 26, No. 2 - January 17, 1997 $$INDEX BEGIN ******************************************************* NOTICES $$INDEX N1 ********************************************************** PROCEDURES FOR ACCESSING REGIONAL PRIMATE RESEARCH CENTERS National Center for Research Resources INDEX: RESEARCH RESOURCES $$INDEX N2 ********************************************************** EXTENSION OF COOPERATIVE AGREEMENTS: WOMEN'S INTERAGENCY HIV STUDY National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute on Drug Abuse National Cancer Institute National Institute of Dental Research INDEX: ALLERGY, INFECTIOUS DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT $$INDEX N3 ********************************************************** RECEIPT OF APPLICATIONS FOR NIAMS P60 GRANTS National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$INDEX R1 03/18/97 ************************************************* SMALL GRANT PROGRAM FOR THE NIAMS (RFA AR-97-001) National Institute of Arthritis and Musculoskeletal and Skin Diseases INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES $$INDEX R2 04/18/97 ************************************************* EXPLORATORY GRANTS IN CHRONIC RENAL FAILURE IN CHILDREN (RFA DK-97-007) National Institute of Diabetes and Digestive and Kidney Diseases INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES $$INDEX R3 04/22/97 ************************************************* HELICOBACTER PYLORI AND ITS RELATIONSHIP TO DIGESTIVE DISEASES AND CANCER (RFA DK-97-003) National Institute of Diabetes and Digestive and Kidney Diseases National Cancer Institute National Institute of Allergy and Infectious Diseases Office of Research on Minority Health American Digestive Health Foundation INDEX: DIABETES, DIGESTIVE, KIDNEY DISEASES; CANCER; ALLERGY, INFECTIOUS DISEASES; MINORITY HEALTH; AMERICAN DIGESTIVE HEALTH FOUNDATION $$INDEX R4 05/08/97 ************************************************* PREVENTION AND CESSATION OF TOBACCO USE BY CHILDREN AND YOUTH IN THE U.S. (RFA CA-97-010) National Cancer Institute National Institute of Child Health and Human Development National Institute of Nursing Research INDEX: CANCER; CHILD HEALTH, HUMAN DEVELOPMENT; NURSING RESEARCH $$INDEX R5 05/08/97 11/13/97 **************************************** NOVEL TECHNOLOGIES FOR EVALUATION OF MOLECULAR ALTERATIONS IN TISSUE (RFA CA-97-011) National Cancer Institute National Institute on Deafness and Other Communication Disorders INDEX: CANCER; DEAFNESS, OTHER COMMUNICATIONS DISORDERS $$INDEX R6 05/15/97 ************************************************* WOMEN'S INTERAGENCY HIV STUDY DATA MANAGEMENT AND ANALYSIS CENTER (RFA AI-97-001) National Institute of Allergy and Infectious Diseases INDEX: ALLERGY, INFECTIOUS DISEASES $$INDEX R7 06/11/97 ************************************************* INNOVATIVE APPROACHES FOR MICROSCOPIC TRACT-TRACING (RFA MH-97-001) National Institute of Mental Health National Institute on Aging INDEX: MENTAL HEALTH; AGING $$INDEX P1 ********************************************************** RESEARCH ON MUSCULOSKELETAL FITNESS AND SPORTS MEDICINE (PA-97-025) National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute of Nursing Research INDEX: ARTHRITIS, MUSCULOSKELETAL, SKIN DISEASES; CHILD HEALTH, HUMAN DEVELOPMENT; NURSING RESEARCH ERRATA $$INDEX E1 CA-97-001 ************************************************ PHASE I TRIALS OF ANTI-CANCER AGENTS (RFA CA-97-001) National Cancer Institute INDEX: CANCER The NIH GUIDE is available electronically via LISTSERV subscription, and is also on the nih gopher (gopher.nih.gov) and the NIH web site (http://www.nih.gov). Alternative access is available through the NIH Grant Line via modem (data line 301/402-2221); contact Dr. John James at 301/435-2801 for details on the NIH Grant Line. All competing (new, renewal, amended (revised) applications for grants, cooperative agreements, and fellowships from the National Institutes of Health must be sent to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) ASKNIH is a service of the Division of Extramural Outreach & Information Resources, Office of Extramural Research, Office of the Director, NIH. ASKNIH is the point of contact for obtaining general information about NIH extramural research & research training programs, requesting publications, and learning more about obtaining the NIH GUIDE and other information on the NIH web site. ASKNIH is also the contact to which organizations should request application kits and forms. ASKNIH NATIONAL INSTITUTES OF HEALTH EMAIL: ASKNIH@ODROCKM1.OD.NIH.GOV FAX: (301) 480-0525 TELEPHONE: (301) 435-0714 INQUIRIES ABOUT THE NOTICES, PAS, AND RFAS IN THIS PUBLICATION SHOULD BE DIRECTED TO THE NIH STAFF MEMBER IDENTIFIED AT THE END OF EACH ITEM. 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. $$INDEX END ********************************************************* NOTICES $$N1 BEGIN ********************************************************** PROCEDURES FOR ACCESSING REGIONAL PRIMATE RESEARCH CENTERS NIH GUIDE, Volume 26, Number 2, January 17, 1997 P.T. 04; K.W. 1014006, 1002002, 078000 National Center for Research Resources The purpose of this notice is to publicize standardized procedures and criteria for utilizing the resources available through the seven Regional Primate Research Centers (RPRCs) to conduct research relevant to the missions of the National Institutes of Health (NIH). The RPRCs, each of which is closely affiliated with an academic institution, are a unique national network of nonhuman primate research and resource centers for biomedical and behavioral investigations. These centers provide the appropriate environment and resources for the development and study of nonhuman primate models essential for clinical and basic research on human health problems and disease processes. Through support from the National Center for Research Resources (NCRR), the centers provide specialized research facilities, nonhuman primate resources, professional and scientific staff, equipment, and technological expertise that enable studies to be done by scientists who use these resources. The facilities and resources are thus shared by RPRC staff scientists, as well as with investigators from other institutions across the country. The centers' specialized resources are intended to assist investigators who receive their primary research funding from NIH, but the centers may also host investigators who are funded by other Federal, state and local agencies, as well as by research foundations and the private sector. There are over 19,000 animals, mostly macaques, representing over 30 different species of nonhuman primates at these centers. Each of the RPRCs has a Visiting Scientist Program, which allows advanced training and research in nonhuman primate biology. In addition, collaborative arrangements between investigators and center scientific staff are encouraged and can be developed on studies related to major human diseases, subject to the availability of resources and center staff time. Further, nonhuman primate blood samples, organs, and biological fluids are available through the RPRCs. The following standardized criteria and procedures have been implemented at each of the RPRCs to facilitate utilization of center resources by research investigators: Criteria: o The nature and scope of the proposed research must be best conducted with nonhuman primates and compatible with available center resources. o The proposed research must have high scientific merit as determined by peer review. o NIH-funded research takes precedence over research activities funded from other sources. o Grants must contain appropriate budgets for the RPRC portion, including animal per diems, RPRC service charges, and related items. Note that sharing of animals during experimentation, as well as the return of the animals to the colony for future experimental use, are contributing factors to the overall costs. o Resources, including animals, space, research services and support must be available, and special requirements such as biosafety facilities must be considered. o Because of potential contamination (e.g., viral, microbial, etc.), movement of animals into or out of the RPRC facilities is not allowed. Thus, the proposed research using live animals must use RPRC animals, and the research must be conducted at the RPRC. Procedures for access: 1) An initial research proposal must be submitted by the researcher to the director of a RPRC. The director then consults with the research services, veterinary, and colony management staff members at the center to assess resource availability and project feasibility. (Note that special requests or conditions regarding animals of certain age, gender, weight, or other stipulations impact on the RPRC's capability to meet the researcher's needs.) 2) Once resource availability and project feasibility are established, the center staff will provide budget information to the researcher regarding the center costs to be included in the formal research proposal. 3) The scientific merit of the proposal must then be evaluated through the NIH peer review process or through a similar process at other agencies. However, small pilot projects with other funding sources may be considered. In the latter cases, the peer review is conducted by the RPRC director's Research Advisory Committee. 4) In addition to the scientific peer review, an approved protocol >From the investigator's as well as the RPRC institutional animal care and use committees (IACUC) must be in place as well as protocols established for any possible biosafety concerns. (Note that these issues can be addressed simultaneously with the scientific evaluation but are frequently raised during the peer review process.) 5) Once the investigator has received notification of funding, the center director should be immediately advised so that the resources at the center may be reserved for the funded proposal. 6) Access to biological materials such as blood samples, organ tissues, and biological fluids can be obtained by direct contact with the directors and staff of the centers. Information on availability of these materials can be located on NCRR's Home Page on the World Wide Web site: http://www.ncrr.nih.gov All publications resulting from research conducted at or with center resources must bear an appropriate acknowledgment of center support. INQUIRIES For additional information about the Visiting Scientist Program and resources available at a specific center, including applying to utilize a center's resources, contact the center director noted below. Andrew G. Hendrickx, Ph.D., Director California Regional Primate Research Center University of California, Davis Davis, CA 95616 Telephone: (916) 752-0420 FAX: (916) 752-8201 URL: http://www.primate.ucdavis.edu/crprc/homepage.html Ronald D. Hunt, D.V.M., Director New England Regional Primate Research Center One Pine Hill Drive Southborough, MA 01772 Telephone: (508) 624-8002 FAX: (508) 460-0612 M. Susan Smith, Ph.D., Director Oregon Regional Primate Research Center 505 N.W. 185th Avenue Beaverton, OR 97006 Telephone: (503) 645-1141 FAX: (503) 690-5532 URL: http://www.teleport.com/~orprc Peter J. Gerone, Sc.D., Director Tulane Regional Primate Research Center 18703 Three Rivers Road Covington, LA 70433 Telephone: (504) 892-2040 FAX: (504) 893-1352 URL: http://www.tpc.tulane.edu William R. Morton, V.M.D., Director Washington Regional Primate Research Center P.O. Box 357330 University of Washington Seattle, WA 98195-7330 Telephone: (206) 543-0440 FAX: (206) 685-0305 Joseph W. Kemnitz, Ph.D., Interim Director Wisconsin Regional Primate Research Center University of Wisconsin - Madison 1220 Capitol Court Madison, WI 53715-1299 Telephone: (608) 263-3500 FAX: (608) 263-4031 URL: http://www.primate.wisc.edu Thomas R. Insel, M.D., Director Yerkes Regional Primate Research Center Emory University 954 Gatewood Road, N.E. Atlanta, GA 30329 Telephone: (404) 727-7707 & 727-7721 FAX: (404) 727-0623 URL: http://www.cc.emory.edu/YERKES/ Inquiries regarding the Regional Primate Research Center Program are encouraged and may be directed to: Jerry A. Robinson, Ph.D. Director, Regional Primate Research Centers and AIDS Animal Models Program Comparative Medicine National Center for Research Resources 6705 Rockledge Drive, Suite 6030, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0744 FAX: (301) 480-3819 Email: jerryR@ep.ncrr.nih.gov $$N1 END ************************************************************ $$N2 BEGIN ********************************************************** EXTENSION OF COOPERATIVE AGREEMENTS: WOMEN'S INTERAGENCY HIV STUDY NIH GUIDE, Volume 26, Number 2, January 17, 1997 P.T. 34, II; K.W. 0715008, 0765033, 0745020, 0745027, 0745070 National Institute of Allergy and Infectious Diseases National Institute of Child Health and Human Development National Institute on Drug Abuse National Cancer Institute National Institute of Dental Research The National Institute of Allergy and Infectious Diseases (NIAID) has an active interest in the support of research projects addressing epidemiologic, etiologic, and pathogenetic patterns and trends in HIV infection and AIDS in various population groups. Studies are currently supported that focus on minorities, children, mothers and infants, women, and men. One of these studies is the WOMEN'S INTERAGENCY HIV STUDY (WIHS), which was initiated in 1993 and is currently supported through cooperative agreements. In addition to the NIAID, the National Institute of Child Health and Human Development (NICHD), the National Institute on Drug Abuse (NIDA), the National Cancer Institute (NCI) and the National Institute of Dental Research (NIDR) support awards in the WIHS. Because the current awardees have unique access to the study cohorts, study data, and study specimens and have unique expertise with respect to the integration of these elements, the NIAID, the NICHD, the NIDA, the NCI and the NIDR intend to invite applications for competitive renewal of these studies through a competition limited to the current awardees only. Although competition for this cooperative agreement study extension is limited, NIAID wishes to call attention to its ongoing interest in applications for prospective studies related to the etiology, pathogenesis, prevention, diagnosis, and treatment of HIV infection and its sequelae. INQUIRIES For further information contact: Paolo Miotti, M.D., M.P.H. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C09 Bethesda, MD 20892-7620 Telephone: (301) 402-0135 FAX: (301) 402-3211 $$N2 END ************************************************************ $$N3 BEGIN ********************************************************** RECEIPT OF APPLICATIONS FOR NIAMS P60 GRANTS NIH GUIDE, Volume 26, Number 2, January 17, 1997 P.T. 34; K.W. 0710030, 1014006 National Institute of Arthritis and Musculoskeletal and Skin Diseases The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) announces that October 1, 1997, will be the last receipt date for new or renewal applications for P60 grants (Multipurpose Arthritis and Musculoskeletal Diseases Centers) under the current guidelines dated December 1994. Depending on the availability of funds, amended applications for P60 grants may be accepted using existing guidelines until October 1, 1998. INQUIRIES For further information contact: Dr. Julia B. Freeman Director, Centers Program National Institute of Arthritis and Musculoskeletal and Skin Diseases 45 Center Drive MSC 6500 Bethesda, MD 20892-6500 Telephone: (301) 594-5052 FAX: (301) 480-4543 Email: Freemanj@ep.niams.nih.gov $$N3 END ************************************************************ NOTICES OF AVAILABILITY (RFPs/RFAs/PAs) $$R1 BEGIN AR-97-001 FULL-TEXT ************************************** SMALL GRANT PROGRAM FOR THE NIAMS NIH GUIDE, Volume 26, Number 2, January 17, 1997 RFA AVAILABLE: AR-97-001 P.T. 34; K.W. 0705050, 0715010, 0715185, 0715136, 0715031 National Institute of Arthritis and Musculoskeletal and Skin Diseases Application Receipt Date: March 18, 1997 PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is seeking small grant (R03) applications to stimulate and facilitate the entry of promising new investigators into targeted, high priority areas of NIAMS research. This one-time solicitation will provide support for pilot research that is likely to lead to a subsequent individual research project grant (R01) or a First Independent Research Support and Transition (FIRST) (R29) award application. It is estimated that $1.0 million (total costs) will be available to support approximately 12 to 15 awards under this program. Awards are contingent on the availability of appropriated funds and on the receipt of sufficiently meritorious applications meeting the stated eligibility requirements. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Small Grant Program for the NIAMS, is related to the priority area of chronic diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-11474-0 or Summary Report: Stock No. 017-001-11473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Dr. Susana A. Serrate-Sztein National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building, Room 5AS-37G Bethesda, MD 20892-6500 Telephone: (301) 594-5032 FAX: (301) 480-4543 Email: SzteinS@ep.niams.nih.gov $$R1 END ************************************************************ $$R2 BEGIN DK-97-007 FULL-TEXT ************************************** EXPLORATORY GRANTS IN CHRONIC RENAL FAILURE IN CHILDREN NIH GUIDE, Volume 26, Number 2, January 17, 1997 RFA AVAILABLE: DK-97-007 P.T. 34, AA; K.W. 0715133 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: March 18, 1997 Application Receipt Date: April 18, 1997 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) recognizes the need to enhance research activities in Pediatric Nephrology. The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the NIDDK invites exploratory/developmental (R21) grant applications to encourage and facilitate studies designed to develop and/or apply new promising experimental tools to the understanding of the pathophysiology and pathogenesis of events resulting in chronic renal failure and its complications, in children. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA) Exploratory Grants in Chronic Renal Failure in Children, is related to the priority area of chronic disabling diseases and food safety. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone (202) 512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Gladys H. Hirschman, M.D. Division of Kidney, Urologic and Hematologic Diseases National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-13 - MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7717 FAX: (301) 480-3510 Email: gladys_hirschman@nih.gov $$R2 END ************************************************************ $$R3 BEGIN DK-97-003 FULL-TEXT ************************************** HELICOBACTER PYLORI AND ITS RELATIONSHIP TO DIGESTIVE DISEASES AND CANCER NIH GUIDE, Volume 26, Number 2, January 17, 1997 RFA AVAILABLE: DK-97-003 P.T. 34; K.W. 0715035, 0715085, 0715125, 0785055 National Institute of Diabetes and Digestive and Kidney Diseases National Cancer Institute National Institute of Allergy and Infectious Diseases Office of Research on Minority Health American Digestive Health Foundation Letter of Intent Receipt Date: March 21, 1997 Application Receipt Date: April 22, 1997 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases, the National Cancer Institute, the National Institute of Allergy and Infectious Diseases (NIAID), and the Office of Research on Minority Health in partnership with the American Digestive Health Foundation invite applications for basic and clinical research focusing on the role of Helicobacter pylori infection in peptic ulcer disease, nonulcer dyspepsia, and gastric cancer, particularly in minority populations. Studies on the epidemiology of Helicobacter pylori in minority populations, genetic susceptibility to and the acquisition of Helicobacter infection, the role of Helicobacter in development and the regulation of the inflammatory response are encouraged. The support for this RFA will be through the NIH research project grant (R01) award, the FIRST (R29) award, and the small grants (R03) award. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Helicobacter Pylori and its Relationship to Digestive Diseases and Cancer, is related to the area of chronic disabling conditions. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Frank A. Hamilton, M.D., M.P.H. Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 6AN-12B Bethesda, MD 20892-6600 Telephone: (301) 5944-8877 FAX: (301) 480-8300 Email: hamiltonf@ep.niddk.nih.gov $$R3 END ************************************************************ $$R4 BEGIN CA-97-010 FULL-TEXT ************************************** PREVENTION AND CESSATION OF TOBACCO USE BY CHILDREN AND YOUTH IN THE U.S. NIH Guide, Volume 26, Number 2, January 17, 1997 RFA AVAILABLE: CA-97-010 P.T. 34, AA; K.W. 0745027, 0404019 National Cancer Institute National Institute of Child Health and Human Development National Institute of Nursing Research Letter of Intent Receipt Date: March 15, 1997 Application Receipt Date: May 8, 1997 PURPOSE The Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI), the National Institute of Child Health and Human Development (NICHD) and the National Institute of Nursing Research (NINR) seek grant applications for innovative research that has clear implications for the immediate and significant reduction of tobacco use by children and youth in the United States. This RFA will use the National Institutes of Health (NIH) individual research project grant (R01). Approximately $4.6 million, per year, in total costs for four years will be committed to fund applications that are submitted in response to each of the two solicitations of this Request for Applications (RFA). It is anticipated that eight to twelve new individual awards will be made through this solicitation. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Prevention and Cessation of Tobacco Use by Children and Youth in the U.S., is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017 001-00474-0 or Summary Report: Stock No. 017 001-00473-1) through the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Thomas J. Glynn, Ph.D. Division of Cancer Prevention and Control National Cancer Institute 6130 Executive Boulevard, Room 243 Bethesda, MD 20892-7330 Telephone: (301) 496-8520 FAX: (301) 496-8675 Email: glynnt@dcpcepn.nci.nih.gov Norman Krasnegor, Ph.D. Human Learning and Behavior Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B05 Rockville, MD 20852 Telephone: (301) 496-6591 FAX: (301) 480-7773 Email: Krasnegn@hd01.nichd.nih.gov June R. Lunney, Ph.D. Division of Extramural Activities National Institute of Nursing Research Building 45, Room 3AN-12 Bethesda, MD 20892-6300 Telephone: (301) 594-6908 FAX: (301) 480-8260 Email: Jlunney@EP.NINR.NIH.GOV $$R4 END ************************************************************ $$R5 BEGIN CA-97-011 FULL-TEXT ************************************** NOVEL TECHNOLOGIES FOR EVALUATION OF MOLECULAR ALTERATIONS IN TISSUE NIH GUIDE, Volume 26, Number 2, January 17, 1997 RFA AVAILABLE: CA-97-011 P.T. 34; K.W. 1002004, 1002008, 0760015, 0755040 National Cancer Institute National Institute on Deafness and Other Communication Disorders Letter of Intent Receipt Date: February 15, 1997 and August 15, 1997 Application Receipt Date: May 8, 1997 and November 13, 1997 PURPOSE The Technology Development Branch of the Cancer Diagnosis Program, Division of Cancer Treatment, Diagnosis and Centers (DCTDC), National Cancer Institute (NCI) and the Division of Human Communication of the National Institute on Deafness and Other Communication Disorders (NIDCD) invite applications proposing the development of novel technologies to facilitate generation of a comprehensive molecular profile of human tissues. Development of these innovative technologies is intended to impact the discovery process in research on the biology of human disease at the level of both gene discovery and molecular cellular biology. This initiative supports development of efficient, cost effective, sensitive technologies to permit the simultaneous, rapid evaluation of the spectrum of molecular alterations in tissue specimens and, ultimately, in single cells. These technologies can be designed to detect genome-wide molecular alterations at the level of DNA, RNA or protein. Investigators may propose technologies to scan the entire genome of a cell or tissue for constellations of cytogenetic changes or other DNA alterations. They may also propose development of technologies to identify changes in gene expression at the level of both RNA and protein. Technologies to evaluate the function status of proteins including proteins of cellular regulatory pathways are also appropriate. As a secondary goal, this initiative is intended to encourage the development of all components of integrated analytical systems including preparation of samples, sample analysis and appropriate informatics systems for data collection and analysis. Applications may be submitted as either research project grants (R01s) or exploratory/developmental grants (R21s). Investigators with sufficient preliminary data are encouraged to apply for funding using the R01 grant mechanism. Use of the R21 mechanism is designed to support applications where insufficient preliminary data has been generated to support a full R01 application. Approximately $1.5 million from NCI and $150,000 from NIDCD will be available to support six to eight grants. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Novel Technologies for Evaluation of Molecular Alterations in Tissue, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, special application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH Gopher (gopher.nih.gov) and the NIH Website (http://www.nih.gov), and by mail and e-mail from the program contact listed below. James W. Jacobson, Ph.D. Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 513, MSC 7388 Bethesda, MD 20892-7388 Telephone: (301) 496-1591 FAX: (301) 402-1037 Email: JJ37D@NIH.GOV Kenneth A. Gruber, Ph.D. Division of Human Communication National Institute on Deafness and Other Communication Disorders 6120 Executive Boulevard, Room 400-C, MSC 7180 Bethesda, MD 20892-7180 Telephone: (301) 402-3458 FAX: (301) 402-6251 Email: kenneth_gruber@nih.gov $$R5 END ************************************************************ $$R6 BEGIN AI-97-001 FULL-TEXT ************************************** WOMEN'S INTERAGENCY HIV STUDY DATA MANAGEMENT AND ANALYSIS CENTER NIH GUIDE, Volume 26, Number 2, January 17, 1997 RFA AVAILABLE: AI-97-001 P.T. 34, II; K.W. 0715008, 0755018 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: March 7, 1997 Application Receipt Date: May 15, 1997 PURPOSE The Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) announces the availability of a Request for Applications (RFA) cooperative agreements (U01) to provide data management, statistical and administrative support to the Women's Interagency HIV Study (WIHS). The purpose of this RFA is to solicit applications from institutions interested in operating as the Women's Interagency HIV Study Data Management and Analysis Center (WDMAC). This initiative will permit the continuation of ongoing studies of HIV in women under the WIHS initiative and will provide a support mechanism for new, highly focused studies of HIV in women using the WIHS infrastructure. The overall objective of this RFA is to provide leadership in study design and analytical methodology for the WIHS and to provide the study with data management, coordination and quality assurance of the data. The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $ 1,500,000. In fiscal year 1997, the NIAID anticipates making one award as a result of this RFA. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA for the Women's Interagency HIV Study Data Management and Analysis Center, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Paolo G. Miotti, M.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C09 Bethesda, MD 20892-7620 Telephone: (301) 402-0135 FAX: (301) 402-3211 $$R6 END ************************************************************ $$R7 BEGIN MH-97-001 FULL-TEXT ************************************** INNOVATIVE APPROACHES FOR MICROSCOPIC TRACT-TRACING NIH GUIDE, Volume 26, Number 2, January 17, 1997 RFA AVAILABLE: MH-97-001 P.T. 34; K.W. 0705055, 1013038, 0780005, 0755020 National Institute of Mental Health National Institute on Aging Letter of Intent Receipt Date: April 15, 1997 Application Receipt Date: June 11, 1997 PURPOSE The National Institute of Mental Health (NIMH) and the National Institute on Aging (NIA) invite applications for grant support to research and develop innovative tract-tracing approaches to study the connectivity of the nervous system at the level of the light and/or electron microscope. Particularly encouraged are applications which propose research and development of novel tract-tracing techniques to be used in post-mortem human and animal tissue, especially aldehyde-fixed tissue. All applications proposing research on innovative tract-tracing approaches will, however, be considered pertinent to this Request for Applications (RFA). This RFA is issued in response to the need for better ways to demonstrate neural connections in humans and in nonhuman animal models. Research and development of novel methods and/or reagents to clearly, reproducibly, and rapidly trace distant connections at the level of the light and/or electron microscope in post-mortem tissue would represent a major advance in the understanding of normal and pathological brain organization. Among the opportunities that this would make available would be direct comparisons of the detailed connectivity of circuits that underlie important mental functions across normal animals, aged animals, animal models of disease, non-diseased humans and humans with mental disorders and age-related nervous system disorders. Moreover, the ability to trace connections in aldehyde-fixed tissue would allow such methods to be used in conjunction with a variety of other methods currently used to study the microstructure of the brain. It is estimated that approximately $1,000,000 will be available to fund between eight to twelve research project grants (R01) and small grant (R03) awards. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Innovative Approaches for Microscopic Tract-Tracing, is related to the priority areas of mental health, mental disorders, and age-related brain disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The RFA, which describes the research objectives, application procedures, review considerations and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301-402-2221) and the NIH GOPHER (gopher.nih.gov) and the NIH Website (http://www.nih.gov), and by mail and Email from the program contacts listed below. Michael F. Huerta, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health Parklawn Building, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-3563 FAX: (301) 443-1731 Email: mhuerta@helix.nih.gov Bradley C. Wise, Ph.D. Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3C307, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: wiseb@gw.nia.nih.gov $$R7 END ************************************************************ $$P1 BEGIN PA-97-025 FULL-TEXT ************************************** RESEARCH ON MUSCULOSKELETAL FITNESS AND SPORTS MEDICINE NIH GUIDE, Volume 26, Number 2, January 17, 1997 PA AVAILABLE: PA-97-025 P.T. 34; K.W. 0705050, 0710020, 0715027, 0715136, 0745030, 0765020, 0785205 National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institute of Child Health and Human Development National Institute of Nursing Research PURPOSE The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the National Institute of Nursing Research (NINR) invite investigator-initiated research grant applications to study a broad range of basic and clinical topics related to musculoskeletal fitness, exercise physiology and sports medicine. The National Center for Medical Rehabilitation Research of the National Institute of Child Health and Human Development (NCMRR/NICHD) encourages applications for both basic and clinical studies of musculoskeletal fitness and exercise physiology of persons with physical disabilities. Under this program announcement, the NIAMS and NICHD will support investigator-initiated research project grants (R01), First Independent Research Support and Transition (FIRST) (R29) awards, small grants (R03), program projects (P01), career development grants (K01, K02, K08), and Investigator-Initiated Interactive Research Project Grants (IRPG.) The IRPG is described in PA-96-001, published in the NIH GUIDE, Vol. 24, No. 35, October 6, 1995. The Principal Investigator and participating investigators will plan, direct, and perform the research. Applicants for program project grants are requested to contact the NIAMS representative listed below as early as possible in the planning stages. The NINR will support individual research project grants (R01 and R29.) 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), Research on Musculoskeletal Fitness and Sports Medicine, is related to the priority area of physical activity and fitness. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). INQUIRIES The PA, which describes the research objectives, application procedures, review considerations, and award criteria for this solicitation, may be obtained electronically through the NIH Grant Line (data line 301/402-2221), the NIH GOPHER (gopher.nih.gov), and the NIH Website (http://www.nih.gov), and by mail and email from the program contact listed below. Richard W. Lymn, Ph.D. Muscle Biology and Musculoskeletal Fitness Program Director National Institute of Arthritis and Musculoskeletal and Skin Diseases Natcher Building Room 5AS 49E Bethesda, MD 20892-6500 Telephone: (301)594-5128 FAX: (301)480-4543 Email: lymnr@ep.niams.nih.gov Danuta Krotoski, Ph.D. National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development Building 61E Room 2A-03 Bethesda, MD 20893-7510 Telephone: (301) 402-2242 Email: krotoskd@hd01.nichd.nih.gov J. Taylor Harden, Ph.D., RN Division of Extramural Programs National Institute of Nursing Research Building 45, Room 3AN-12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5976 FAX: (301) 480-8260 Email: THARDEN@ep.ninr.nih.gov $$P1 END ************************************************************ ERRATA $$E1 BEGIN R1 19961122 APPEND RFA CA-97-001 BOTH *********************** PHASE I TRIALS OF ANTI-CANCER AGENTS NIH GUIDE, Volume 26, Number 2, January 17, 1997 RFA AVAILABLE: CA-97-001 P.T. 34; K.W. 0715015, 0740020, 0755010, 0715035 National Cancer Institute The following correction is issued for RFA CA-97-001, which was published in the NIH Guide, Vol. 25, No. 40, November 22, 1996: APPLICATION PROCEDURES A. PREPARATION OF APPLICATION ALL Applicants Item 1 below is revised to read: 1. Investigators should include in the appendix of the cooperative agreement application copies of protocols that have been approved or conducted recently or drafts of relevant protocols that demonstrate the application of the proposed approach or relevant area of expertise. They should identify the particular areas of laboratory expertise that would be utilized in the performance of trials under this cooperative agreement. INQUIRIES Inquiries regarding this RFA may be directed to: Dr. Michaele C. Christian Division of Cancer Treatment, Diagnosis and Centers National Cancer Institute 6130 Executive Boulevard, Room 734 - MSC 7432 Bethesda, MD 20892-7432 Telephone: (301) 496-5223 FAX: (301) 480-4663 Email: christim@DCT.NCI.NIH.GOV $$E1 END ************************************************************ From owner-sci-resources@net.bio.net Mon Jan 27 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA MH-97-001 - V26(02) 01/17/97 Date: 27 Jan 1997 16:24:20 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 443 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5cjgvk$dln@net.bio.net> NNTP-Posting-Host: net.bio.net INNOVATIVE APPROACHES FOR MICROSCOPIC TRACT-TRACING NIH GUIDE, Volume 26, Number 2, January 17, 1997 RFA: MH-97-001 P.T. 34; K.W. 0705055, 1013038, 0780005, 0755020 National Institute of Mental Health National Institute on Aging Letter of Intent Receipt Date: April 15, 1997 Application Receipt Date: June 11, 1997 PURPOSE The National Institute of Mental Health (NIMH) and the National Institute on Aging (NIA) invite applications for grant support to research and develop innovative tract-tracing approaches to study the connectivity of the nervous system at the level of the light and/or electron microscope. Particularly encouraged are applications which propose research and development of novel tract-tracing techniques to be used in post-mortem human and animal tissue, especially aldehyde-fixed tissue. All applications proposing research on innovative tract-tracing approaches will, however, be considered pertinent to this Request for Applications (RFA). This RFA is issued in response to the need for better ways to demonstrate neural connections in humans and in nonhuman animal models. Research and development of novel methods and/or reagents to clearly, reproducibly, and rapidly trace distant connections at the level of the light and/or electron microscope in post-mortem tissue would represent a major advance in the understanding of normal and pathological brain organization. Among the opportunities that this would make available would be direct comparisons of the detailed connectivity of circuits that underlie important mental functions across normal animals, aged animals, animal models of disease, non-diseased humans and humans with mental disorders and age-related nervous system disorders. Moreover, the ability to trace connections in aldehyde-fixed tissue would allow such methods to be used in conjunction with a variety of other methods currently used to study the microstructure of the brain. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Innovative Approaches for Microscopic Tract-Tracing, is related to the priority areas of mental health, mental disorders, and age-related brain disorders. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for small grants (R03) from the NIMH (for additional eligibility requirements for NIMH small grants, see PAR-97-015, NIH Guide for Grants and Contracts, Vol. 25, No. 4, December 6, 1996). MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) and small grant (R03). Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an R01 grant application submitted in response to this RFA may not exceed four years. An R03 grant application submitted in response to this RFA, may request up to $50,000 per year (direct costs) for up to two years and may include salary support for the principal investigator. The anticipated award date is September 1997. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. Because the small grant has special eligibility requirements, application formats, and review criteria, applicants are strongly encouraged to consult with program staff listed under INQUIRIES and obtain the appropriate additional announcements for that grant mechanism. FUNDS AVAILABLE It is estimated that approximately $1,000,000 will be available for research projects (R01) and small grants (R03) funded under this RFA. It is expected that this will support eight to twelve such awards, depending upon the mix of mechanisms. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Although the financial plans of NIMH and NIA include these proposed levels of support, awards made under this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Neural circuits form the neural substrate of the complex information processing carried out in the brain in both health and illness. Not only does the function of the central nervous system depend upon the connections that are made by its constituent neurons, but the function of any given region of the brain depends upon the particular connections that region has with other regions of the nervous system. This tenet holds from the level of groups of neurons, such as a cortical area or subcortical nucleus, all the way down to the level of the individual neuron and even to the subcellular level. Not surprisingly, much of contemporary understanding of brain function, as well as the formulation of new hypotheses, is based on knowledge regarding specific connections of particular brain regions or neurons. In the last 20 years, the development and use of a variety of tracer substances (e.g., tritiated amino acids, horseradish peroxidase, fluorescent dyes, dextrans, and biocytin), approaches (e.g., histochemistry, immunolabeling, fluorescence microscopy, and autoradiography) and reagents (e.g., diaminobenzidene and tetramethylbenzidene) have produced explosions of new data and insights. Most tract-tracing approaches, however, require the deposit of tract-tracing substances in vivo, and depend on axoplasmic flow for their transport. This mechanism renders difficult the use of such methods in some areas of animal research, such as study of brain connectivity early in development, and, of course, precludes their use in humans. There are very few tract-tracing approaches that can be applied to post-mortem tissue, and these approaches have severe limitations such as being capricious, extremely slow, or being able to demonstrate connections only over very small distances. Thus, despite the wealth of knowledge that has accumulated regarding neural connectivity in a variety of species, very little is known about the detailed connections of the human brain. The ability to demonstrate detailed distant neural connections in human post-mortem tissue would permit direct comparison of the normal connectional organization of the human brain with the vast literature on neural connections obtained in animal models and would allow a more critical evaluation of the relationship of animal models of brain disorders to human disease. Obversely, this capacity would also reveal the alterations of neural circuits associated with specific pathologies, such as Alzheimer's Disease and other neurodegenerative diseases, and would facilitate the development of better animal models of these pathologies. This technique could also delineate changes in neural circuits, including axonal degeneration, which are seen in normal and pathological aging. Since it is likely that approaches capable of demonstrating neural connections in human pos-mortem tissue would also work in non-human post-mortem tissue, these tools would represent important additions to the arsenal of techniques available to study connections in nonhuman species. Experimental approaches and disciplinary perspectives brought to bear on research proposed by applicants are unrestricted and may be multidisciplinary or interdisciplinary. The following are examples of some of the research topics that would be relevant to this RFA: o identification and evaluation of molecules which rapidly diffuse through lipids fixed in aldehydes, such as those aldehydes used to fix human tissue; o development of procedures to visualize tract-tracing molecules in aldehyde-fixed tissue; o evaluation of efficacy of novel tract-tracing methods across different neural systems, across different species, and across different ages; o studies of parameters limiting the uptake and/or movement of novel agents along axons and diffusion between neural cells; o assessment of novel tract-tracing molecules to identify local neural circuits as well as long distance neural connections; o structure-function models to predict the efficacy of specified molecules to demonstrate connections in post-mortem timmue; o evaluation of the ability of novel tract-tracing molecules to identify degenerating or dysfunctional axons in animal models of neuronal degeneration; o evaluation of the compatibility of novel tract-tracing methods with other commonly used methods of microstructural analysis, such as immunolabeling or histochemical staining; o development of procedures to co-visualize novel tract-tracing molecules with cell-specific markers in order to identify specific neuronal populations and their connections. These broad objectives are meant to be illustrative and are not exclusive of other objectives appropriate to this RFA. Since the purpose of this RFA is to stimulate research and development of new tract-tracing approaches, an important aspect of the proposed efforts is the manner in which these new approaches will be evaluated and compared to existing approaches. This evaluation should be scientifically valid, objective, and as quantitative as possible. Scientific interaction among principal investigators supported as a result of this RFA is encouraged. 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 28, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 15, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIMH and NIA staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Michael F. Huerta, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health Parklawn Building, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-3563 FAX: (301) 443-1731 Email: mhuerta@helix.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 435-0714, FAX (301) 480-0525, Email: ASKNIH@ODROCKM1.OD.NIH.GOV. Guidelines for NIMH small grants (R03) are available on the NIMH home page (www.nimh.nih.gov) under research grants (PAR-97-015), the NIMH FAX4U (301-443-4513), and or may be obtained from the NIMH program director listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number, "MH-97-001; Innovative Approaches for Microscopic Tract-Tracing", must be typed in section 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight mail service) At the time of submission, two additional copies of the application must be sent to: Henry J. Haigler, Sr., Ph.D. Division of Extramural Activities National Institute of Mental Health Parklawn Building, Room 9C-08 Rockville, MD 20857 Telephone: (301) 443-1340 FAX: (301) 594-0702 Email: hhaigler@ngmsmtp.nimh.nih.gov Applications must be received by June 11, 1997. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness by NIMH and NIA staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIMH in accordance with the review criteria stated below. 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 will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board, when applicable. 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 likelihood that the work will advance the ability to demonstrate neural connectivity; o appropriateness and adequacy of plans to evaluate tract-tracing approaches developed under this RFA; 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, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA o potential to advance the field; o scientific merit of the proposed research as determined by peer review; o responsiveness to the purposes and objectives outlined in this RFA; o availability of research funds; o programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Michael F. Huerta, Ph.D. Division of Neuroscience and Behavioral Science National Institute of Mental Health Parklawn Building, Room 11-103 Rockville, MD 20857 Telephone: (301) 443-3563 FAX: (301) 443-1731 Email: mhuerta@helix.nih.gov Bradley C. Wise, Ph.D. Neuroscience and Neuropsychology of Aging Program National Institute on Aging 7201 Wisconsin Avenue, Suite 3C30 - MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-9350 FAX: (301) 496-1494 Email: wiseb@gw.nia.nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Rockville, MD 20857 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov Joseph Ellis Grants Management Officer National Institute on Aging 7201 Wisconsin Avenue, Suite 2N212 - MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: ellisj@gw.nia.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (NIMH) and 93.866 (NIA). 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. Awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement (April 1, 1994). PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the nonuse 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. From owner-sci-resources@net.bio.net Mon Jan 27 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA AI-97-001 - V26(02) 01/17/97 Date: 27 Jan 1997 16:24:01 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 948 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5cjgv1$dkp@net.bio.net> NNTP-Posting-Host: net.bio.net WOMEN'S INTERAGENCY HIV STUDY DATA MANAGEMENT AND ANALYSIS CENTER NIH GUIDE, Volume 26, Number 2, January 17, 1997 RFA: AI-97-001 P.T. 34, II; K.W. 0715008, 0755018 National Institute of Allergy and Infectious Diseases Letter of Intent Receipt Date: March 7, 1997 Application Receipt Date: May 15, 1997 PURPOSE The purpose of this Request for Applications (RFA) is to provide data management, statistical and administrative support to the Women's Interagency HIV Study (WIHS). This will permit the continuation of ongoing studies of HIV in women under the WIHS initiative and will provide a support mechanism for new, highly focused studies of HIV in women using the WIHS infrastructure. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Women's Interagency HIV Study Data Management and Analysis Center, is related to the priority area of HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Stock No. 017-001-10473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, units of State or local government, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. Domestic applications may not include international components. Applications from minority individuals and women are encouraged. MECHANISM OF SUPPORT The administrative and funding mechanism to be used to undertake this program will be the Cooperative Agreement (U01), an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity, by involvement in and otherwise stimulating and working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships, and governance of the WIHS Study to be funded under cooperative agreement(s) are discussed later in this document under the section Terms And Conditions of Award. The total project period for applications submitted in response to this RFA may not exceed five years. At present, the NIAID is administratively limiting the duration of U01 cooperative agreements to four years; this administrative limitation may change in the future. At this time, the NIAID has not determined whether and how this solicitation will be continued beyond the present RFA. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for awards under this RFA will be $ 1,500,000. In fiscal year 1997, the NIAID anticipates making one award as a result of this RFA. At the current time, NIH is limiting annual inflationary increases to four percent. The usual PHS policies governing grants administration and management will apply. This level of support is dependent on the receipt of applications of high scientific merit. Although this program is provided for in the financial plans of the NIAID, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. RESEARCH OBJECTIVES A. Background 1. HIV IN WOMEN. HIV in women is increasing worldwide. In the U.S., the epidemic began expanding among women in the late 1980s. Since many HIV-infected women in the U.S. have not yet progressed to advanced disease stages, the full extent of the epidemic in this population has yet to be clearly defined. As of December 1995, the Centers for Disease Control and Prevention (CDC) estimated that the cumulative number of AIDS cases in adult and adolescent women in the U.S. was more than 71,000, with 13,764 in 1995 alone. Women now comprise approximately 14 percent (71,818/513,486) of the total adult and adolescent AIDS cases, the highest proportion yet reported. The impact of AIDS is particularly severe in minority populations. Among women in the U.S., Blacks and Hispanics combined now represent the majority of AIDS cases (76%). In the U.S., the proportion of women acquiring HIV infection through sexual contact with HIV-infected men is increasing and expected to become the predominant mode in the next few years. In 1995, 38% of women with AIDS reported acquiring HIV infection through sexual contact, and 38% reported injecting-drug use as their main exposure category. AIDS is now the third leading cause of death for women aged 25 to 44, after cancer and cardiovascular disease. As new knowledge on HIV/AIDS is more rapidly generated, ongoing prospective cohort studies must rapidly adjust their structure to the new developments. Studies of HIV/AIDS in women can play a unique role in testing new biological or socio-behavioral hypotheses and in linking basic science findings and laboratory methods to epidemiologically well defined populations. 2. WIHS The Women's Interagency HIV Study (WIHS), a multicenter, prospective study, was established in 1993 in tandem with a similar study, the HIV Epidemiology Research Study (HERS) coordinated by the U.S. Centers for Disease Control and Prevention (CDC) to carry out comprehensive investigations of the impact of HIV infection in women. The six WIHS sites, organized as consortia, are located in New York (2), Washington, Chicago, San Francisco and Los Angeles (Principal Investigators and respective study sites are identified below, under STUDY POPULATIONS). In addition to the NIAID, other NIH Institutes (the National Institute of Child Health and Human Development, the National Institute on Drug Abuse, the National Cancer Institute and the National Institute of Dental Research) fund different components of the WIHS. The WIHS has solicited the community's input from the outset to better identify problems and pursue research opportunities that are relevant in the area of women and HIV. A total of 2,641 women (2066 HIV positive and 575 negative), 80% of minority background, are under follow-up. A key objective of the continuation of the WIHS initiative is to stimulate investigators to design and conduct studies that fully utilize the network of WIHS sites, laboratories, specimen bank and data center and to encourage the integration of new studies in this established network. This goal will be more easily attained because the facilities participating in the WIHS also provide clinical care to the members of the WIHS cohort, which allows for real-time clinical observation and laboratory testing. The rapid implementation of new protocols will be especially dependent on the presence of the following project-wide characteristics: adequate infrastructure and coordination within the consortia, effective linkage between the six study sites, real-time coordination of activities by the data center, and optimal use of the clinical specimens which are being stored at an NIAID-funded repository. All activities of the WIHS are coordinated and supervised by an Executive Committee (see TERMS AND CONDITIONS OF AWARD) which collaboratively decides all scientific, policy and organizational issues concerning development and implementation of research protocols, structure and membership of working groups, publications, access to data and interim data monitoring, and access to biological specimens. The specific activities related to data collection, management analysis and quality assurance, specimen tracking, staff training as well as study-wide communication, coordination and administrative duties have been carried out, since the study's inception, by the WIHS Statistical and Clinical Coordinating Center (SACCC). Besides carrying out such activities for the WIHS, the SACCC has been simultaneously functioning as the Data Center for other NIH-funded (WITS) and CDC-funded (HERS) studies. The aim of this RFA is to replace the SACCC with a WIHS-specific Data Center (WDMAC), as described in detail below. B. Research objectives and scope The overall objective of this RFA is to ensure leadership in study design and analytical methodology for the WIHS, and to provide the study with management, coordination and quality assurance of the data. A comprehensive plan is sought in several specific areas, as described below. Applicants may identify discrete areas, among those described in this RFA, for which they plan to utilize outside contractors. This approach is encouraged if it allows the respondent to more efficiently carry out the numerous tasks that are part of the responsibilities of the WIHS Data Management and Analysis Center (WDMAC). Applicants should describe the activities to be contracted, the level of integration between the WDMAC and any contractor, and the expected advantages of such an approach. 1. Statistical and research design leadership. The WDMAC will provide leadership and intellectual input about statistical and design aspects of the study. The WDMAC's responsibilities, therefore, will include providing expert assistance to WIHS investigators in developing design and analytic approaches, estimating sample size requirements for specific research questions, planning and performing interim and final analyses, and preparing reports that summarize the results of such statistical analyses. These responsibilities apply to multiple, simultaneous projects, including those funded by collaborating NIH Institutes. Expertise in theoretical statistics, modeling, repeated measures, exploratory data analysis and robust methods will be important for the investigations in the next WIHS funding cycle. A sound methodological approach to the measurement of disease progression, based on currently used or new surrogate markers, will be necessary in a number of WIHS studies where key events, such as time of HIV seroconversion, are unknown. Statistical methods that are relevant to the current WIHS scientific questions should be described. The WDMAC is expected to play a catalytic role in its interaction with the WIHS sites and to establish, in collaboration with the Executive Committee, priorities and reasonable timelines for study activities. The WDMAC also is expected to collaborate with investigators conducting new, discrete studies in the WIHS. Technical assistance provided by the WDMAC to new WIHS collaborators is particularly important to ensure that study design and implementation are compatible with the WIHS instruments. Data should be provided to these collaborators as needed and as approved by the Executive Committee. For ongoing studies as well as new collaborations, the WDMAC's responsibilities include, besides providing expertise for statistical and research design, the creation of cohesive teams of statisticians and clinical/laboratory investigators. These teams can function best when regularly monitored by the WDMAC's Principal Investigator and when formed early in the process leading to presentation and publication of WIHS results. The WDMAC will have the opportunity to engage in methodological investigations, and to develop novel methodological approaches, utilizing data from the WIHS. The standardized instruments for data collection and management used by this large prospective study will provide an opportunity for methodological investigations. For example, these data may be useful in evaluating the effectiveness of treatments for AIDS or AIDS-related conditions outside of clinical trials, the role of confounders in such evaluations, and the representativeness of specific subpopulations. These data also may be applied to the investigation of novel methodologic approaches to estimate changes in survival from different stages of HIV infection. 2. Transition of data, data software and equipment. Applicants should provide a detailed plan for an orderly and efficient transition from the current data management contractor. Transition activities will be conducted in collaboration with the outgoing data center during an overlap period of approximately six months. Specifications regarding the data currently maintained centrally, and the hardware and software currently in use, will be provided to RFA applicants to facilitate transition planning and to allow them to formulate plans regarding any new configurations of electronic data collection, management and analysis. A brief summary of the current WIHS software environment is included as an Appendix to this RFA. A similar plan also should be provided by the applicants for turning over activities to a new data center at the termination of the next grant period. Applicants should describe specific activities to effect the smooth transfer of the data and to phase in new systems and phase out old systems, including relevant software and equipment. For transition phase activities also, applicants may choose to utilize contractors for specific tasks, if more efficiency in this phase will ensue. 3. Data management and quality assurance system. a. Data Management System. The WDMAC will be responsible for ensuring the continued quality of the data management system and its adequacy to the expanding needs of the WIHS. This includes establishment of an optimal computing environment for processing, storage and retrieval of data at a central data management facility. The application should describe how multiple sets of longitudinal information are concatenated and how data files for analyses are created. The WDMAC should maintain and update an information management system for tracking transmission and receipt of data from the study sites as well as maintain and update codebooks, active files and inventory files. Combined codebooks may be needed to interface with other AIDS databases, such as the AIDS Malignancy Bank Database. The WDMAC should implement regular data back-ups centrally and at the sites, and archiving of one data copy off-site should be provided. The data base should be accessible by multiple users simultaneously and have security systems to prevent unauthorized access to data, as well as record-keeping procedures which ensure participants' confidentiality. b. Summary data. The WDMAC will be responsible for preparing and updating operations manuals and data collection forms and providing statistical summary reports, including regularly providing summary data on participants' attendance to site Project Directors and the Participant Retention Working Group. The regular dissemination of attendance reports will help to ensure that the participants' retention rates are correctly interpreted by the sites and that problems are brought to the attention of the site, the Executive Committee, NIAID and other participating NIH Institutes in a timely manner. The WDMAC should solicit and integrate comments from WIHS Working Groups; distribute this information and Working Group minutes to Principal Investigators, Executive Committee, Working Groups and NIH Institutes; distribute summary reports containing descriptive statistics of participants; and maintain and regularly distribute a list of all publications, manuscripts in progress and presentations which used data from the WIHS. Emphasis should be placed on completing the above tasks in a timely manner. For budgeting purposes, it should be assumed that such data summaries will be required twice a year. Activities such as minute taking and mailings to sites, Working Groups and Committees may be performed through a subcontractor, if this demonstrably allows for a more efficient service and a better utilization of the WDMAC's resources for other key WIHS activities. c. Protocol monitoring and modifications. The WDMAC should monitor adherence to the clinical and laboratory protocols, and coordinate implementation of any new or modified protocols that the Executive Committee approves during the course of the study. WDMAC activities related to new or modified protocols include new data collection form development, data management system modifications, operations and training manual updates and the conduct of study sites' staff training. d. Quality assurance. A study-wide quality assurance system should be implemented by the WDMAC to allow for regular evaluation of reliability, validity and completeness of data. Statistical expertise by the WDMAC will be critical in the implementation of quality assurance programs in the sites' laboratories. The WDMAC should manage and, if necessary, improve the current quality assurance system and provide documentation of any changes in the quality assurance and data entry instruction manuals. The WDMAC should bring any data suggesting quality assurance problems at study sites to the attention of NIAID, other collaborating NIH Institutes and the WIHS Executive Committee. The WDMAC will play a central role in discussing such problems and suggesting solutions at the periodic WIHS Executive Committee meetings. For studies requiring discipline-specific expertise not readily available within the WIHS, the WDMAC should plan to procure the services of experts to assure the quality of such study data. e. Relationship with study sites and site visits. A key requirement for the smooth conduct of a complex study such as the WIHS is the ability of RFA respondents to work with the other WIHS investigators and with external collaborators in a cooperative and collegial fashion. To further this goal, the WDMAC will be a full member of the WIHS Executive Committee. Data collected by the WIHS clinical sites and stored at the WDMAC are considered the property of the study as a whole and are thus governed by the formal decision processes of the WIHS. The WDMAC is expected to abide by the Executive Committee's decisions, which includes providing readily usable data sets to researchers based at WIHS sites, researchers associated with the WIHS through investigator-initiated studies, or external WIHS collaborators, as required and approved by the WIHS Executive Committee. An important element in the daily conduct of the study is adequate support to the field operations. The WDMAC should provide data collection support and field calls about data-related matters >From site project directors, clinicians and laboratory staff. Carefully prepared site visits are an integral part of the support effort. A WDMAC team of individuals with different expertise is expected to visit each of the six WIHS main sites in the first 18 months of this grant's funding period. After the first visit, the frequency of subsequent visits will be determined in collaboration with NIAID and co-sponsoring NIH Institutes. To ensure that needs identified during visits are rapidly addressed, post-site visit reports should be submitted to NIAID within one month of each site visit. Likewise, separate reports by the WDMAC on studies supported by other NIH Institutes will be crucial to delineate deficiencies and rapidly implement recommendations. The WDMAC will be responsible for any staff training needs during these periodic site visits. f. Site-specific studies and WDMAC studies. A major strength of the WIHS is the combined data set from the participating study sites. However, important findings may be generated by smaller studies at individual WIHS sites. Subsequent to Executive Committee approval, a WIHS site will have the opportunity to perform research and analysis on data collected solely from that site, but site-specific studies will be limited in size and scope. The role of the WDMAC for site-specific work will mainly be to provide clean and up-to-date data sets to the sites submitting requests. The WDMAC also will have the opportunity to propose and perform independent methodological and biostatistical research with WIHS-wide data. Such WDMAC proposals will also require the Executive Committee's approval. 4. Study-wide communication, co-ordination and administrative duties. The WDMAC will have overall responsibility for the following activities: a. Establish electronic mail linkages among sites, the WDMAC, NIAID and other participating NIH Institutes. b. Develop milestones/timelines to identify major steps and anticipated accomplishments. Particular attention is necessary in setting milestones in the following areas: transition from the previous data center; revision of questionnaires and protocols and pilot testing of new procedures; methods of data input; distribution of instruments/operation manuals; ongoing training of clinical site staff; implementation of quality assurance protocols. c. Provide regularly spaced data freezes, based on a schedule established by the Executive Committee. d. Provide meeting-related administrative support for Executive Committee and Working Group meetings. This includes coordinating with the working group chairs to distribute agendas, preparing 1-2 page highlights of meetings and conferences calls and working with the Executive Committee to assemble, organize and distribute materials for study-wide Working Group and Executive Committee meetings. Type and frequency of meetings are described below under MEETINGS. e. Arrange for regular conference calls for Working Groups, Executive Committee and other ad hoc committees or study-related groups. 5. Specimen tracking system for the storage and retrieval of biological specimens. The WDMAC should provide central co-ordination of stored specimens in collaboration with staff of the NIAID National AIDS Biological Specimen Repository, under contract to Biological Resources, Inc. of Rockville, MD. This includes updating and improving as needed the current system for specimen tracking at each stage (collection, processing, transfer, storage and retrieval). The WDMAC should also plan to submit a biannual inventory of specimens >From each clinical site, describing the type and quantity of all specimens. This inventory should be provided to the NIAID AIDS Specimen Repository via electronic medium in a format that can be integrated into inventory databases. To facilitate the evaluation of new studies by the Executive Committee, a repository status summary should be prepared and distributed to the Executive Committee members before their scheduled meetings. The WDMAC should also record requests for biological specimens and work with the repository and the Laboratory Working Group to account for the current amount and type of specimens available. In addition, the WDMAC should conduct training and updates about the procedures to keep track of repository specimens centrally and at the clinical sites. Project directors of clinical sites and other appropriate personnel are expected to attend these training sessions. 6. Protocol-oriented clinical research training of site staff. As part of a study-wide quality assurance system, the WDMAC should conduct periodic evaluations and site visits for clinical assessment, form completion, specimen collection monitoring and ongoing staff training. In particular, the WDMAC will be responsible for the following evaluations: interview skills and procedures, HIV pre-test and post-test counseling, specimen collection skills and procedures, and data management at local sites. It is recommended that the visiting team include at least one physician or physician's assistant or nurse practitioner. At least one team member must be fluent in Spanish. 7. Support and coordination for data presentation at scientific conferences. The WDMAC should coordinate with WIHS investigators the process generating scientific material for presentations at conferences and meetings. Specific WDMAC responsibilities include playing a proactive role in devising original approaches to study design and data analysis, performing such analyses, and prioritizing efforts for presentations in collaboration with the Executive Committee. The WDMAC also should play a central role in the yearly WIHS-wide scientific meetings in which study results are presented and discussed. The WDMAC should provide in a timely fashion datasets for analyses by WIHS investigators and outside collaborators, as requested by the Executive Committee. 8. Communication with WIHS sites and NIH. Regular reporting of activities will help the WIHS sites, as well as the Executive Committee and the participating NIH ICs, to monitor progress and identify areas of potential interest for further investigation. For such reports, a reader-friendly format which limits the narrative and incorporates clear tables and figures is encouraged. This communication format also applies to a transition period report (if applicable) describing in detail accomplishments and challenges in all activities that are part of the WDMAC transition plan. In addition to the annual report to NIAID/other Institutes, the WDMAC should plan to produce at regular intervals (at least twice a year) a summary of study descriptive statistics, participants' attendance to clinics and inventory of biological specimens from each clinical site (with type and volume of all specimens). TERMS AND CONDITIONS OF AWARD These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used shall be a cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIAID scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIAID's and NIH's purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee for the project as a whole, although specific tasks and activities in carrying out the study will be shared among the awardee and the NIAID Program Officer or designees. Under the cooperative agreement, a relationship will exist between the award recipient and the NIAID in which the awardee is responsible for the requirements and conditions described below and agrees to accept program assistance from a named NIAID Program Officer or other designated government official in achieving project objectives, as described below. Failure of an awardee to meet the performance requirements, including these special terms and conditions of award, or significant changes in the level of performance, may result in a reduction in budget, withholding of support, or suspension and/or termination of the award. 1. EXECUTIVE COMMITTEE. All activities of the WIHS are coordinated and supervised by an Executive Committee whose membership currently consists of: Principal Investigators, Project Directors, Working Group chairs, the Data Center representative, the Community Advisory Board (CAB) representative, the Program Officer of each funding NIH Institute, and the Program Officer of the CDC companion study (HERS). The Executive Committee collaboratively decides all scientific, policy and organizational issues concerning development and implementation of research protocols, structure and membership of working groups, publications, access to data and interim data monitoring, and access to biological specimens. The WIHS Executive Committee will be in charge of assuring that the overall conduct of the study is in keeping with high standards of scientific and programmatic achievement and that adequate mechanisms for systematic oversight of the research quality are in place. Principal Investigators will be responsible for ensuring and demonstrating to the Executive Committee that their study site and consortium subsites adequately contribute to the overall effort. The Principal Investigator of the WDMAC will be a full member of the Executive Committee. From an organizational standpoint, the Executive Committee will place particular emphasis on monitoring the coordination between study sites and WDMAC and on monitoring access to biological samples. 2. AWARDEE RESPONSIBILITIES. The WDMAC awardee is responsible for all the activities necessary to achieve the project's Research Objectives, including the following: o Research design and protocol development, including definition of objectives and approaches, planning, implementation, data collection, quality control, interim data monitoring, final data analysis and interpretation. o Establishing appropriate mechanisms for quality control and monitoring. o Establishing and maintaining a relationship with WIHS sites, NIAID and other collaborating NIH Institutes which facilitates the achievement of the study objectives. o Preparing and submitting to the NIH progress reports. A summary of the WDMAC's activities and progress should be sent annually to the NIAID (and other NIH Institutes, if applicable) Program Officer. o Cooperating in the reporting of the study findings. 3. RESPONSIBILITIES OF WIHS SITES. The quality of the WIHS research will largely depend on the degree of collaboration between the WIHS sites and the WDMAC. The generation of high-quality data in a multi-center setting will require continuous feedback by the sites to the WDMAC for data management and protocol implementation. The responsiveness of the sites in providing information to the WDMAC will be the responsibility of the WIHS Principal Investigators. In particular, sites will be responsible for: o Providing adequate and timely response to all pertinent requests by the WDMAC concerning past, ongoing, or planned research activities. o Immediate reporting of problems in data collection, record abstraction and information flow. o Immediate reporting of staff changes. o Attendance at training sessions by staff. o Submitting complete and clear analysis proposals in the standard format previously developed by the WDMAC. Requests for expedited analysis will require a written justification. o Submitting complete and clear WIHS abstract/manuscript concept sheets. o Maintaining hardware and software in optimal working condition and coordinating changes and/or upgrades. o Ensuring that all requests to the WDMAC are timely and well documented. Every effort should be made to rapidly resolve any disagreements between individual WIHS sites and the WDMAC. In case of persisting problems, the matter will be referred to the Executive Committee. 4. NIAID AND OTHER FUNDING INSTITUTES' RESPONSIBILITIES. Although scientific leadership will be the responsibility of the WIHS Executive Committee and Principal Investigators, NIAID will provide substantial assistance through the Program Officer, in the form of scientific co-ordination and advice. Coordination and advice in areas pertaining to the other funding NIH Institutes will be provided by their responsible Program Officer. o NIH Program staff will monitor study results and quality assurance across all sites, in order to ensure the production of high-quality, unbiased results that are comparable across sites. o NIH Program staff will ensure and coordinate access to WIHS datasets for presentations and publication of study-wide data, to achieve even representation and multi-site contribution to the core group of WIHS subjects. Program staff will have access to and may periodically review all study protocols and data. o NIH Program Staff will oversee the collection, storage and cataloguing of samples and will ensure that appropriate access is given to the repository of biological specimens, which is a key resource for the entire scientific community. o NIH Program Staff may also exercise the option of periodic external review of progress of the WIHS, in order to ensure an optimal use of approaches and resources. 5. ACCESS TO DATA. The WDMAC, in collaboration with the Executive Committee, will be responsible for optimizing the mechanism for access to data for exploratory work or manuscript preparation. It is critical that both WDMAC and site investigators operate in a spirit of collaboration, and understand the importance of data sharing as well as the possible technical constraints of the process. Requests by investigators for raw and summary data should be managed in a timely manner by the WDMAC after clearance and prioritization by the Executive Committee. The WDMAC will provide to each center a full set of cleaned, site-specific data twice each year. The complete WIHS dataset will be kept at the WDMAC. 6. BIOLOGICAL SPECIMENS. In view of the importance of biological specimens for current and future studies, their number and volume should be regularly monitored by the WDMAC and reported to the Executive Committee and the Principal Investigators. Each site's annual report to NIAID and other Institutes should include the WDMAC's summary report on biological specimens and a detailed status report of any local repository. Problems in specimen collection by individual sites should be brought to the attention of the Executive Committee, through the WDMAC and the working groups, for appropriate remedial measures. WIHS specimens may be made available only after Executive Committee clearance. Requests for specimens by WIHS investigators should describe in detail the study for which specimens are sought, their number and volume, in accordance with a standardized WIHS Data and Specimen request form. WIHS specimens may also be made available to independent investigators upon approval of requests by the Executive Committee. 7. DISSEMINATION OF STUDY RESULTS. The existing WIHS publication policy (as described in a detailed document issued in June, 1995 and approved by the Executive Committee) should be followed. The policy will be reviewed in the first six months of the funding cycle and amended, if necessary, to achieve overall fairness and timeliness in the formal reporting of research results. The timely dissemination of study results to the communities involved is strongly emphasized. Support by NIAID and other participating NIH Institutes should be acknowledged in all publications. 8. MEETINGS: The Executive Committee is expected to meet at least twice per year. Active WIHS Working Groups are expected to meet at least twice per year to present and discuss their data. An annual WIHS-wide meeting will convene Executive Committee and Working Groups at the same location. The WDMAC should ensure the availability of updated summary data for these meetings. The WDMAC is encouraged to hold an annual retreat in which research results and future plans are presented and discussed in detail. 9. ARBITRATION. Disagreements between awardees in the implementation of study matters will be resolved by the Executive Committee in collaboration with NIAID and with any other NIH Institutes involved in the specific matter. If necessary and upon request of the parties involved, an arbitration panel will be constituted. The panel will be composed of a member selected by the WIHS Executive Committee (with NIH members non voting), a member selected by NIAID (with input from other Institutes, if applicable) and a member selected by the two previously selected members. This special arbitration in no way affects the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D and HHS regulations at 45 CFR Part 16. STUDY POPULATIONS. WIHS sites and composition of consortia: o New York (PI: Dr. K. Anastos). Consortium sites: Montefiore/Bronx Lebanon, Beth Israel, Mt. Sinai; o New York (PI: Dr. H. Minkoff). Consortium sites: SUNY Brooklyn, Kings County, University Hospital. o Washington, DC (PI: Dr. M. Young). Consortium sites: Georgetown U., Howard U., G. Washington, Whitman-Walker, Montgomery County Health Dept., Inova Health System. o Chicago (PI: Dr. M. Cohen). Consortium sites: Cook County Hospital, Northwestern Memorial Hospital, Rush Presbyterian/St. Lukes, U. of Illinois. o San Francisco (PI: Dr. R. Greenblatt). Consortium sites: UCSF, San Francisco General Hospital, Alameda County Medical Center, Alta Bates Medical Center. o Los Angeles (PI: Dr. A. Levine). Consortium sites: U.S.C. Medical Center, Martin Luther King Medical Center, AIDS Healthcare Foundation, T.H.E. Clinic for Women, Prototypes/W.A.R.N., Santa Barbara Health Dept., U. of Hawaii. 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 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 current 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 28, 1994 (FR 59 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11] . Investigators may obtain copies from these sources or from Dr. Paolo G. Miotti (listed in INQUIRIES below) who may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 7, 1997 a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 5/95). Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910; telephone (301) 435-0714; e-mail ASKNIH@odrockm1.od.nih.gov. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES" and the RFA number AI-97-001 and the words "WIHS Data Management and Analysis Center" must be entered on the face page. Applications must be received by May 15, 1997. Applications that are not received on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 5/95) Application Kit (as modified in and superseded by, the special instructions below, for the purposes of this RFA), will be judged non-responsive and will be returned to the applicant. The RFA label in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. If the application submitted to this RFA is substantially similar to a grant application already submitted to the NIH for review, but that has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore an application that is essentially identical to the one that has already been reviewed cannot be submitted in response to this RFA. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. It is recommended that Dr. Paolo G. Miotti, NIAID Division of AIDS, be consulted before submitting the letter of intent and during the early stages of preparation of the application. See program contacts under INQUIRIES. Applications should include funds for such meetings in their budget requests. [Note: for planning purposes, assume two Executive Committee meetings and two meetings of each active Working Group per year. One such meeting of the Executive Committee and the Working Groups will occur at the same location, during the annual WIHS-wide meeting. Meeting venues are rotated among the participating WIHS sites. Approximately 20 persons attend Executive Committee meetings. Attendance at Working Group meetings varies in accordance with the size of the specific Working Group.] Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-spaced photocopies, in one package to: Division of Research Grants National Institutes of Health 6701 Rockledge Drive, Room 1040-MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) At the time of submission, two additional exact copies of the grant application and all five sets of appendix material must also be sent to Dr. Dianne Tingley, Scientific Review Program at the address listed under INQUIRIES. RESEARCH PLAN PAGE LIMIT. Each application (Sections a through d) should not exceed 50 pages. For additional information, refer to page 8 of the PHS 398 application form. REVIEW CONSIDERATIONS Review Method Upon receipt, applications will be reviewed for completeness by the NIH Division of Research Grants (DRG) and for responsiveness by NIAID staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, it will be returned without further consideration. Those applications judged by the reviewers to be competitive for award will be further reviewed for scientific and technical merit by a review committee convened by the Division of Extramural Activities, NIAID. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council. Review Criteria The basic review criteria for this RFA are those for unsolicited research grant applications. Successful applications should describe a coherent and detailed plan to provide scientific leadership, data management and statistical expertise, and administrative services to a large multicenter study of HIV/AIDS in women in the U.S. Specific rating criteria will include the following: 1. Strength of qualifications, research experience, and time commitments of the WDMAC Principal Investigator and other key staff, for the following activities: a. providing statistical and scientific leadership for study design and analysis in longitudinal multicenter HIV studies; and b. successful management and operation of a data center serving multiple collaborating sites and managing complex data sets. 2. Adequacy of plans for developing and maintaining systems for collection, storage, analysis, and quality control of study data, with appropriate security, confidentiality and timeliness. 3. Scientific impact and originality of approaches to protocol development and data analysis for clinical, epidemiologic and laboratory studies effectively utilizing WIHS specimens. 4. Adequacy of plans for monitoring progress of the various WIHS studies, and reporting interim and final results in a responsive and timely manner. 5. Adequacy of plans for effectively interfacing with the WIHS sites, working groups, and staff of NIAID and other Institutes (as appropriate), including establishment of an electronic mail system capable of exchanging messages through the internet. 6. Adequacy of the proposed administrative structure to carry out the proposed activities, and of the resources and facilities available to support the study. 7. Adequacy of plans for a rapid and orderly transition from the current system to a new system, and for transitioning to a new grantee at the end of the award period, should that prove necessary. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program needs and balance, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Paolo G. Miotti, M.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C09 Bethesda, MD 20892-7620 Telephone: (301) 402-0135 FAX: (301) 402-3211 Email: pm122m@nih.gov Direct inquiries regarding review issues, address the letter of intent to, and mail two copies of the application and all five sets of appendices to: Dianne E. Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C07 Bethesda, MD 20892 Bethesda, MD 20851 (for express/courier service) Telephone: (301) 496-2550 FAX: (301) 402-2638 Direct inquiries regarding fiscal matters to: Ms. Ann Devine Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C23 Bethesda, MD 20892 Telephone: (301) 402-5601 Schedule Letter of Intent Receipt Date: March 7, 1997 Application Receipt Date: May 15, 1997 Scientific Review Date: July 1997 Advisory Council Date: September 1997 Earliest Award Date: November 1997 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, 93.856 - Microbiology and Infectious Diseases Research and 93.855 - Allergy, Immunology and Transplantation Research. Grants are awarded under the authority of the Public Health Service Act, Title III, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations, most specifically at 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant 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. From owner-sci-resources@net.bio.net Mon Jan 27 22:00:00 1997 Path: biosci!biosci!not-for-mail From: BIOSCI Administrator Newsgroups: bionet.sci-resources Subject: NIH GUIDE - RFA CA-97-011 - V26(02) 01/17/97 Date: 27 Jan 1997 16:23:43 -0800 Organization: BIOSCI International Newsgroups for Molecular Biology Lines: 425 Sender: daemon@net.bio.net Approved: biosci-help@net.bio.net Distribution: world Message-ID: <5cjguf$djh@net.bio.net> NNTP-Posting-Host: net.bio.net NOVEL TECHNOLOGIES FOR EVALUATION OF MOLECULAR ALTERATIONS IN TISSUE NIH GUIDE, Volume 26, Number 2, January 17, 1997 RFA: CA-97-011 P.T. 34; K.W. 1002004, 1002008, 0760015, 0755040 National Cancer Institute National Institute on Deafness and Other Communication Disorders Letter of Intent Receipt Date: February 15, 1997 and August 15, 1997 Application Receipt Date: May 8, 1997 and November 13, 1997 PURPOSE The Technology Development Branch of the Cancer Diagnosis Program, Division of Cancer Treatment, Diagnosis and Centers (DCTDC), National Cancer Institute (NCI) and the Division of Human Communication of the National Institute on Deafness and Other Communication Disorders (NICDC) invites applications proposing the development of novel technologies to facilitate generation of a comprehensive molecular profile of human tissues. Development of these innovative technologies is intended to impact the discovery process in research on the biology of human disease at the level of both gene discovery and molecular cellular biology. This initiative supports development of efficient, cost effective, sensitive technologies to permit the simultaneous, rapid evaluation of the spectrum of molecular alterations in tissue specimens and, ultimately, in single cells. These technologies can be designed to detect genome-wide molecular alterations at the level of DNA, RNA or protein. Investigators may propose technologies to scan the entire genome of a cell or tissue for constellations of cytogenetic changes or other DNA alterations. They may also propose development of technologies to identify changes in gene expression at the level of both RNA and protein. Technologies to evaluate the function status of proteins including proteins of cellular regulatory pathways are also appropriate. As a secondary goal, this initiative is intended to encourage the development of all components of integrated analytical systems including preparation of samples, sample analysis and appropriate informatics systems for data collection and analysis. Applications may be submitted as either research project grants (R01s) or exploratory/developmental grants (R21s). Investigators with sufficient preliminary data are encouraged to apply for funding using the R01 grant mechanism. Use of the R21 mechanism is designed to support applications where insufficient preliminary data has been generated to support a full R01 application. Approximately $1.5 million from NCI and $150,000 from NIDCD will be available for each receipt date. It is anticipated that six to eight applications will be funded following each round of review. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Appl