Full Text PA-97-017 HIV-1 INFECTION OF THE CENTRAL NERVOUS SYSTEM NIH GUIDE, Volume 25, Number 44, December 20, 1996 PA NUMBER: PA-97-017 P.T. 34 Keywords: Nervous System AIDS Pathogenesis Treatment, Medical+ National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute on Drug Abuse National Institute of Child Health and Human Development PURPOSE The National Institute of Mental Health (NIMH), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Drug Abuse (NIDA), and the National Institute of Child Health and Human Development (NICHD) invite research grant applications through this Program Announcement (PA) to support research focused on determining the pathogenic mechanisms involved in HIV-1 associated neurobehavioral and neurological dysfunction in adults and children. The objective of this cooperative effort is to foster investigations that will provide the foundation for the rapid development of therapeutic interventions to prevent and treat the effects of HIV-1 on the central nervous system (CNS). Applications ranging from basic research to clinical diagnosis and treatment studies are being solicited. Multidisciplinary research teams and collaborative alliances are encouraged but not required. 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, HIV-1 Infection of the Central Nervous System, 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. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Eligibility and requirements for different funding mechanisms vary. Applicants are advised to contact the relevant program staff listed under INQUIRIES for additional information and specific application procedures. Applications may be submitted by foreign and 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. Foreign institutions are not eligible for small grants (R03), First Independent Research Support and Transition (FIRST) (R29) awards, program projects (P01), or fellowships (F32). Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Grant funds may be used for expenses clearly related and necessary to conduct the proposed research, including both direct and allowable indirect costs. Grant funds may not be used to operate a treatment, rehabilitation, or other service program. Prospective applicants should contact NIH staff to ascertain the dollar and time limitations associated with each program mechanism. Information specific to the Individual Postdoctoral Training Awards (F32): Individuals must be, at time of application, citizens or noncitizen nationals of the United States, or have been lawfully admitted to the United States for permanent residence and have in their possession an Alien Registration Receipt Card (I-151 or I-551). Noncitizen nationals are persons who, although not citizens of the United States, owe permanent allegiance to the United States. They are generally persons born in lands that are not States, but are under United States sovereignty, jurisdiction, or administration (e.g., American Samoa). Individuals on temporary or student visas are not eligible. Individuals must have received, as of the beginning date of the National Research Service Award (NRSA) appointment, a Ph.D., M.D., D.O., D.D.S., D.V.M., O.D., D.P.M., Sc.D., Eng. D., Dr.P.H., or D.N.S., or equivalent degree from an accredited domestic or foreign institution. Certification by an authorized official of the degree granting institution that all degree requirements have been met is also acceptable. Individuals may receive up to three years of aggregate NRSA support at the postdoctoral level including any combination of support from institutional training grants and individual fellowship awards. For additional eligibility criteria, see the NIH Guide, Vol. 25, No. 31, September 20, 1996. MECHANISM OF SUPPORT The mechanisms for support by the in this program announcement are: investigator initiated research project grants (R01), FIRST awards (R29), program project grants (P01), individual postdoctoral fellowship programs (F32) and small research grants (R03). NINDS does not accept applications for the R03 award. Because certain grants have special eligibility requirements (e.g., small grants, program project grants and FIRST awards), application formats, and review criteria; applicants are strongly encouraged to consult with program staff listed under INQUIRIES and obtain the appropriate additional announcements for those grant mechanisms. An applicant planning to submit a new (Type 1) investigator-initiated grant application requesting $500,000 or more in direct costs for any year is advised that he or she must contact Institute program staff before submitting the application, i.e, as plans for the study are being developed. Furthermore, the applicant must obtain agreement from the staff that the Institute will accept the application for consideration for award. Finally, the applicant must identify, in the cover letter that is sent with the application, the staff member and Institute who agreed to accept assignment of the application. Any application subject to this policy that does not contain the required information in the cover letter sent with the application will be returned to the applicant without review. For additional information concerning large grant applications, see the NIH Guide, Vol. 25, No. 14 (May 3, 1996). For FIRST (R29) awards, Just-in-Time procedures will be used. These modified procedures are described in full in the NIH Guide, Volume 25, Number 10, March 29,1996. RESEARCH OBJECTIVES Studies of the neuropathogenesis of HIV-1 infection have enhanced our understanding of the profound impact of HIV disease on both the central and peripheral nervous systems. These effects are common and can result in considerable morbidity and mortality. The recent Report of the NIH AIDS Research Program Evaluation Task Force described neuro-AIDS as "one of the most prominent and dreaded manifestations of HIV infection." Steady progress in the field of neuro-AIDS research has been made. However, answers to critical questions that can be translated into clinical applications are needed. This program announcement is intended to encourage and foster investigations that will address research questions that will provide the foundation for the rapid development of therapeutic interventions to prevent and treat the effects of HIV-1 on the central and peripheral nervous systems. In an effort to intensify the depth, focus and coordination of efforts to address key neuro-AIDS issues, the NIMH, NINDS, NIDA, and NICHD are jointly issuing this Program Announcement. Applicants are encouraged to contact program staff of the appropriate Institute regarding programmatic specific issues. The following are research topics identified by the Institutes, the Office of AIDS Research (OAR), as well as experts in the field to be the most pressing scientific priorities and are provided as examples of research topics pertinent to this Program Announcement. o Research that will determine the pathogenic mechanisms involved in HIV-1 associated neurobehavioral and neurological dysfunction such as: - Determining how HIV enters, establishes infection and persists in the CNS - Determining the molecular and cellular changes underlying HIV-associated CNS dysfunction and their role in CNS dysfunction - Determining the mechanisms and consequences of cellular trafficking between the CNS, CSF and blood in the context of HIV-1 infection - Determining the consequences of the biological activity of cytokines, chemokines and neurotrophins on neurobehavioral and neurological dysfunction associated with HIV-1 infection o Research that will determine the impact of HIV-1/CNS infection on systemic disease progression; and the role of the CNS as a reservoir for HIV infection o Research leading to the development and expansion of methods to diagnose and monitor HIV-1 associated cognitive and motor dysfunction o Research to develop HIV-1 therapeutic agents capable of penetrating the blood-brain-barrier or delivery systems that enhance uptake across the blood-brain-barrier o Research that will determine the mechanisms and consequences of HIV-1 infection that influence the developing nervous system o Research which employs appropriate animal models of HIV-1/CNS disease to test hypotheses regarding the neuropathogenesis of HIV-1 infection and/or test therapeutic interventions o Research to determine the impact of anti-HIV-1 treatments on neurobehavioral and neurological complications of HIV-1 infection o Research to determine the role of opportunistic infections in neurobehavioral and neurologic complications of HIV-1 infection o Research investigating biological, environmental and nutritional factors that impact nervous system function in the context of HIV-1 infection 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. APPLICATION PROCEDURES Applications (with the exception of F32) are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at standard deadlines for AIDS applications as indicated on page 21 of the application kit. Applications for fellowships (F32) are to be submitted on form PHS 416-1 (rev. 8/95); the standard receipt dates for these applications are April 5, August 5, and December 5. Both application kits are available at most institutional offices of sponsored research and may be obtained from Office of Extramural Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910; telephone 301/710-0267; fax 301/480-0525; Email: ASKNIH@ODROCKM1.OD.NIH.GOV. The title, "HIV-1 Infection of the Central Nervous System," and number of the program announcement must be typed on the face page of the application. Applications for the FIRST award (R29) must include at least three sealed reference letters attached to the face page of the original application. FIRST award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. Applications for individual postdoctoral NRSAs (F32) must submit at least three completed reference forms. These forms are enclosed in the PHS 416-1 (rev. 8/95) kit used for individual NRSA applications. The completed original application and five legible copies of the PHS 398 or the original and two copies of the PHS 416-1 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 (for courier/overnight mail service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. 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, applications may 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, when applicable. Review Criteria for R01 and R29: o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. For foreign applications, availability of special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions not readily available in the United States, or that provide enhancement of existing U.S. resources, must be addressed. 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, potential impact and relevance to the field, availability of funds and program priority. INQUIRIES Inquiries regarding this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Walter L. Goldschmidts, Ph.D. Office on AIDS National Institute of Mental Health Parklawn Building, Room 10-75 Bethesda, MD 20857 Telephone: (301) 443-7281 FAX: (301) 443-9719 Email: wgoldsch@nih.gov A. P. Kerza-Kwiatecki, Ph.D. Division of Convulsive, Infectious and Immune Disorders National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 804 Bethesda, MD 20892 Telephone: (301) 496-1431 FAX: (301) 402-2060 Email: ak45w@nih.gov Lynda Erinoff, Ph.D. Office on AIDS National Institute on Drug Abuse Parklawn Building, Room 9A30 Bethesda, MD 20857 Telephone: (301) 443-6046 FAX: (301) 443-4100 Email: le30q@nih.gov Anne Willoughby, M.D., MPH Pediatric, Adolescent and Maternal AIDS Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B11H Bethesda, MD 20892 Telephone: (301) 496-7339 FAX: (301) 496-8678 Email: willouga@hd01.nichd.nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health Parklawn Building, Room 7C-08 Bethesda, MD 20857 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov Dianna Jessee Division of Extramural Activities National Institute of Neurological Disorders and Stroke 7550 Wisconsin Avenue, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 FAX: (301) 402-0219 Email: dj35j@nih.gov Gary P. Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse Parklawn Building, Room 8A54 Bethesda, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov Edgar D. Shawver Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17 Bethesda, MD 20892 Telephone: (301) 496-1303 FAX: (301) 402-0915 Email: shawverd@hd01.nichd.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.242, 93.281, and 93.282 for NIMH, Nos. 93.853 and 93.854 for NINDS,. No. 93.279 for NIDA and 93.865 for NICHD. 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 66, 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. .
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