NOVEL HIV THERAPIES: INTEGRATED PRECLINICAL/CLINICAL PROGRAM Release Date: May 24, 2000 PA NUMBER: PAR-00-098 National Institute of Allergy and Infectious Diseases National Institute of Mental Health Application Receipt Dates: October 10, 2000, 2001, 2002 APPLICATIONS IN RESPONSE TO THIS PROGRAM ANNOUNCEMENT (PA) MUST BE PREPARED USING A MULTI-PROJECT GRANT APPLICATION FORMAT. SPECIFIC INSTRUCTIONS FOR COMPLETING THE APPLICATION ARE IN THE NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (April 1999) - http://www.niaid.nih.gov/ncn/grants/multibron.htm. PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), invites applications for the discovery, preclinical evaluation, development, and pilot clinical studies of novel agents and strategies to suppress HIV replication, interfere with HIV transmission or disease progression, or ameliorate the consequences of infection. The National Institute of Mental Health (NIMH), NIH, invites applications to identify and treat the nervous system complications of HIV infection that result in CNS dysfunction. The Integrated Preclinical/ Clinical Program (IPCP) described in this Program Announcement (PA) supports a continuum of diverse research activities from multidisciplinary groups. Accordingly, applications may emphasize one of the following: (1) research involving preclinical discovery and development of new therapeutics; (2) preclinical research that transitions to clinical studies during the award period; or (3) clinical research of novel, pilot treatment strategies. In combining these activities into a single PA, the IPCP provides a spectrum of research opportunities to collaborative groups interested in any aspect of the discovery and development of new modalities for the treatment of HIV disease. The participation of the private sector is strongly urged. Responsive applications will involve creative and original therapeutic research that targets diverse facets of HIV infection. Excluded from this PA are targets and approaches already under extensive investigation at academic or private sectors, non-targeted random screening of potential inhibitors, and research on AIDS-associated opportunistic pathogens and malignancies. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS led national activity for setting priority areas. This Program Announcement (PA), NOVEL HIV THERAPIES: INTEGRATED PRECLINICAL/CLINICAL PROGRAM, is related to the focus area of HIV Infection. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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. While foreign institutions are not eligible for to apply for Program Project Grant (P01) awards as the principal institution, they may participate under this PA as research projects or cores. However, these components will not receive support for indirect costs. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. The involvement of the private sector is strongly urged because of the infrastructure and capital resources it brings to the program and its potential to rapidly marshal resources and move therapeutic leads through the development pathway. Investigators from the private sector are eligible to participate as Principal Investigators, Project or Core Leaders, or informally as collaborators. MECHANISMS OF SUPPORT The mechanism of support is the Program Project grant (P01). Program Project grants support broadly based, multi-disciplinary research programs that have a well-defined, central research focus or objective. An important feature is that the interrelationships of the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project were pursued individually. The program project grant consists of a minimum of three interrelated individual research projects that contribute to the program objective. This type of award also can provide support for certain common resources termed cores. Such resources should be utilized by two or more projects within the award. The total project period for P01 grants may not exceed four years. At this time the NIAID is administratively limiting the duration of P01 grants to four years; this administrative limitation may change in the future. Research groups supported by this PA include: (1) groups focusing exclusively on preclinical discovery and development of novel therapeutic entities and strategies; and (2) groups positioned to implement a proposed pilot clinical study during the award period. P01 applications submitted in response to this PA may not request in excess of $725,000 first-year total (direct and indirect) costs for research involving preclinical studies, or $1,500,000 first-year total (direct plus indirect) costs for research involving clinical studies. Budgets exceeding these levels must be strongly justified and pre- approved for submission by the Program contact person listed under "INQUIRIES". Groups proposing to transition from preclinical to clinical studies during the award period should submit a budget for each phase that reflects the limits given above. The level of support for clinical research under this PA may be insufficient to provide all the funds necessary to conduct the proposed clinical study. Prospective groups should therefore develop plans to use existing infrastructure and organizational support to complement the award [including NIH sponsored General Clinical Research Centers (GCRC) and Centers for AIDS Research (CFAR)]. Responsibility for the planning, direction, and execution of the proposed research for all applicable mechanisms of support will be solely that of the applicant. Applicants for P01 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (April 1999); this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. RESEARCH OBJECTIVES Background Research advances in recent years have yielded a wealth of information on HIV molecular biology, the pathogenesis of HIV disease, and the impact of disease progression on immune function. Concomitantly, seminal technological advances have been realized. Together, these advances offer exciting opportunities to develop and translate new therapeutic concepts to clinical application and complement current FDA approved therapies. To assist in assembling the diverse scientific expertise and ancillary resources needed to translate basic discoveries to applied entities, this PA is designed to support multi-disciplinary preclinical and clinical research groups. Research Objectives and Scope The objectives of the IPCP are: (1) to maintain a strong and diverse base in preclinical discovery and development of new therapeutics; and (2) to support the translation of innovative treatment concepts from preclinical studies to pilot clinical proof-of-concept studies. The ultimate goal of this PA is the discovery, development, and exploratory clinical evaluation of new and effective therapeutic approaches for the treatment of HIV disease and prevention of HIV sexual transmission. Such research is expected to yield long-term therapeutic returns as well as identify and open new research directions. In line with this objective, the PA will support diverse and creative strategies of sound scientific rationale that are new or under- studied, and provide a continuous spectrum of research opportunities from preclinical to pilot clinical studies. Interdisciplinary research groups will conduct this comprehensive effort. Examples of preclinical and clinical research areas of interest to the IPCP include: 1. Development of under-explored/new drugs and therapeutic concepts that target elements (viral or host) essential for HIV replication and/or pathogenic manifestation(s) 2. Development of strategies or entities that target viral reservoirs (cellular, tissue, organ) 3. Development of cytoreductive strategies as adjunct immune-therapies (e.g., to induce repopulation of immune components) or as preparative regimens for transplantation (hematopoietic stem cells, lymphoid cells, organs) 4. Design and testing of therapeutic vaccines (e.g., DNA-based; vector- based) 5 Identification of topical microbicide inhibitors of HIV sexual transmission (e.g., blockers of HIV fusion and/or entry; gene- and cell-based inhibitors) 6. Evaluation of novel therapeutic strategies in combination with treatment paradigms [e.g., HAART plus cell-based therapy; structured treatment interruption (STI) in conjunction with a therapeutic vaccine, cytokines, others] 7. Identification of molecular and cellular mechanisms underlying HIV- associated CNS dysfunction and development of targeted therapeutics [Current research areas supported by funded groups under the IPCP can be viewed at: http://www.niaid.nih.gov/daids/pdatguide/ipcp.htm.] Preclinical Research The preclinical portion of the IPCP supports the discovery and development of specific therapeutic approaches or strategies. The new therapeutic strategy should have relevance and future application to clinical evaluation. The inclusion of an animal model for proof-of-concept is strongly encouraged. Preclinical groups seeking to transition from preclinical to clinical research during the award period must detail the goals and milestones considered necessary to enter the clinical phase. These goals and milestones should also include plans and a timetable for obtaining the required institutional and government approvals [Institutional review Board (IRB), Institutional Biosafety Committee (IBC), Food and Drug Administration (FDA), NIH Recombinant Advisory Committee (RAC)]. The peer review group will review the appropriateness of the goals and milestones. When a request to transition to the clinical phase is made, these goals and milestones will be also be used to determine the successful completion of the preclinical development phase. Release of funds for clinical research will be contingent upon the documented successful completion of the proposed and peer-reviewed goals and milestones. Clinical Studies The clinical portion of the IPCP supports interdependent, iterative clinical/laboratory research designed to evaluate and optimize a clinical therapeutic approach. Relative to the preclinical portion of the IPCP, human subjects concerns and regulatory issues substantially increase under the clinical phase. These safety and clinical proof-of-concept studies of innovative therapeutic strategies may involve greater scientific risk than that practiced in larger clinical trials. A successful group will develop and optimize a therapeutic strategy to a point at which it can be determined whether the strategy merits further clinical evaluation. Moreover, analysis of outcome should explore reasons for failures as well as successes as part of an overarching objective to further advance the knowledge base and development of new therapeutic modalities. A clinical application must be based on a strategy in an advanced stage of preclinical development that is suitable for evaluation in a small number (6- 12) of patients. [When merited by the study, a larger number of patients may be considered; prior approval by the Program Officer (see INQUIRIES, below) is required.] The application should include (1) a detailed plan of the iterative clinical and laboratory research to be conducted to optimize the proposed strategy; (2) a timetable to be followed; (3) plans for the clinical studies including the clinical protocol; and (4) institutional and government approvals (IRB, FDA, RAC). SPECIAL REQUIREMENTS IPCP Group Scientific Advisory Panel Each IPCP group will designate a Scientific Advisory Panel ("Panel") of 2-3 investigators, not affiliated with any of the institutions comprising the group. The Panel will attend one or more of the IPCP group meetings each year, review the group's activities, and evaluate progress, adherence to the original time frame of activities, and the continued relevance of each project to the group's overall goals. The Panel will recommend new directions as appropriate and will provide the PI with a comprehensive written evaluation of the group's activities and recommendations after each meeting. A copy of the report is to be sent to the DAIDS Coordinator within 30 days of the meeting. [The DAIDS Coordinator for each group will be the equivalent of a Project Officer, having either medical or scientific research expertise depending on the clinical or preclinical focus of the project.] Meetings and travel The NIAID organizes small meetings/workshops throughout the year on topics of interest to IPCP investigators. Awardees are strongly encouraged to participate in these meetings held in the Washington DC area. Applicants should include estimated travel expenses for one such meeting per year in the application budget. Estimated expenses for travel of the Scientific Advisory Board members should be based on one group meeting per year and should be included in the budget. No additional travel funds will be provided to attend other domestic or foreign meetings. TERMS AND CONDITIONS OF AWARD Patent Coverage Since an application may include several institutions, including the private sector, complex patent situations may arise. To avoid delays related to intellectual property issues in implementing new therapies for HIV, each multi-project group is required to provide a plan as part of the application, detailing (1) the approach, agreed to by all parties, to be used for obtaining patent coverage and for licensing, where appropriate; and (2) the procedures to be followed for the resolution of legal problems that potentially may develop. Attention is drawn to the reporting requirements of 35 U.S.C. Parts 200-212 and 37 CFR Part 401 or FAR 55.227-11. Instructions were also published in the NIH GUIDE FOR GRANTS AND CONTRACTS, Vol. 19, No. 23, June 22, 1990. Note that non-profit organizations (including universities) and small business firms retain the rights to any patent resulting from Government grants or cooperative agreements. It is also noted that a Presidential memorandum of February 18, 1983 extended to all business concerns, regardless of size, the first option to the ownership of rights to inventions as provided in P.L. 96-517. As a result of this memorandum, the relationships among industrial organizations and other participants are simplified, since all group members can now be full partners in the research and in any inventions resulting there from. The specific patenting arrangements among the institutions may vary and could include joint patent ownership, exclusive licensing arrangements, etc. Applicants are encouraged to develop an arrangement that is most suitable for the group’s particular circumstances. The patent agreement among the institutions comprising the group, signed and dated by the organizational officials authorized to enter into patent arrangements for each group member and member institution, must be submitted with the application, and a copy submitted to Dr. Nava Sarver (address under INQUIRIES). If the group wishes to place all inventions and discoveries resulting from these studies within the public domain, a letter to that effect must be submitted to Dr. Sarver in lieu of the patent agreement. The letter must be co-signed by the Principal Investigator, each of the Project Leaders, and each of the business officials representing the respective institutions. Federal regulation clause 37-CFR-401 and HHS Inventions regulations at 45 CFR Parts 6 and 8 require that NIH be informed of inventions and licensing occurring under NIH funded research. Invention and licensing reports must be submitted to the Extramural Invention Reports Office at (301) 435-1986. For awards including clinical studies When clinical studies or trials are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. Terms and Conditions of Award will be included with awards. NIAID policy was announced in the NIH Guide on February 24, 2000 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html. The full policy including terms and conditions of award is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf Terms of awards specific to this PA may also apply. Groups seeking to transition from preclinical to clinical studies during the award period must include a long-range development plan that details the preclinical, transitional, and clinical phases of the proposed studies and a budget appropriate to each phase. Funds to accommodate the potentially more costly clinical study should be budgeted in the application. The group must articulate a set of objectives and milestones to be completed prior to the transition to clinical research and include the clinical site and clinical investigators to be involved. For purposes of peer review, the application must include a clinical protocol based on research findings available at the time of submission (although it is understood that the protocol may change as work progresses). All the above components - the development plan, objectives and milestones, clinical site and clinical investigators - will be essential elements of the initial review by the peer review group. The NIAID and/or NIMH will review requests to transition to clinical research and will use outside expertise to review the revised clinical protocol and budget and to assist in determining whether the group requesting transition is positioned to proceed to clinical studies. Release of funds for clinical research will be contingent on successful accomplishment of milestones and criteria stated in the original application as reviewed and approved by the peer review group, and include compliance with all applicable laws and regulations. To initiate clinical studies awardees must have IRB, FDA and RAC (if applicable) approvals. Funds for clinical studies will be withheld until the required approvals are obtained and copies provided to NIAID (Dr. Nava Sarver, address under INQUIRIES). Additional details for applications including a clinical component are listed as follows. The Principal Investigator is responsible for: 1. Assuming responsibility for developing protocols and monitoring study performance; participant recruitment and follow-up; interim data and safety analysis and monitoring. All protocols will be submitted by the Principal Investigator to the NIAID (Dr. Nava Sarver, address below) for review for safety issues by the DAIDS Clinical Science Review Committee (CSRC) prior to implementation. The Principal Investigator will be responsible for reporting recruitment, retention, and other similar information to DAIDS/NIAID at six- month intervals, on January 1 and July 1 of each year. Adverse event reports will be forwarded to Dr. Sarver at the same time as to the FDA. 2. Establishing procedures to comply with FDA regulations for studies involving investigational agents and strategies and to comply with the requirements of 45 CFR Part 46 for the protection of human subjects. Terms of award for any human clinical trial component will be developed to ensure volunteer safety and monitoring of compliance with regulations and Good Clinical Practices. NIAID staff will provide guidance and technical advice on meeting FDA requirements for investigational substances. 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, 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 which is available via the WWW at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and which is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators may obtain copies from these sources or from Dr. Nava Sarver (listed in INQUIRIES below) who may also provide additional relevant information concerning the policy. URLs IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Applicants for P01 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS (April 1999); this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in this Program Announcement. Application kits 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: GrantsInfo@nih.gov. In addition, applications are available at the following URL: http://grants.nih.gov/grants/forms.htm. Applications that are not received as a single package on the receipt date or that do not conform to the instructions contained in PHS 398 (rev. 4/98) Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR -PROJECT AWARDS" (http://www.niaid.nih.gov/ncn/grants/multibron.htm) will be judged non- responsive and will be returned to the applicant. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised to contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC Staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html. For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the PA number listed on the face page of this PA and the words "NOVEL HIV THERAPIES: INTEGRATED PRECLINICAL/CLINICAL PROGRAM" must be typed in. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express mail or courier service) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to Dr. Dianne Tingley at the address listed under INQUIRIES. Concurrent submission of an R01 and a Component Project of a Multi-project Application: Current NIH policy permits a component research project of a multi-project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. 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 could be included with the application. REVIEW CONSIDERATIONS Review Procedures Applications will be assigned on the basis of established NIH referral guidelines. Upon receipt, the NIH Center for Scientific Review will review applications for completeness. Incomplete applications will be returned to the applicant without further consideration. P01 applications that are complete and responsive to this PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID. Review Criteria Applicants are urged to become familiar with the NIAID brochure "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS http://www.niaid.nih.gov/ncn/grants/multibron.htm (April 1999) for specific review criteria for P01 applications. This brochure details the review criteria applicable to the individual projects, individual cores, and the overall application as a whole. These criteria are contained in instructions provided to the peer review panel and will be used as the working frame by which the applications will be evaluated. Specifically, the reviewers will be asked to comment on specific criteria as detailed in the brochure for multi-project application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these review criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. In addition to (not in lieu of) the review criteria detailed in the instruction brochure (see above), review criteria specific to this PA (mainly bearing to the review of the individual preclinical and clinical projects) include, as follows: 1. The medical significance and originality of the project. 2. The likelihood that the research will open new directions in the treatment of HIV disease or containment of HIV infection, demonstrate a capacity to be reduced to clinical practice, or merit evaluation in clinical studies for safety and proof-of-concept. 3. Appropriateness of the experimental approach, development plan, and methodology proposed, including laboratory capabilities (preclinical and/or clinical) in immunology, virology, cell biology; assays to detect changes in parameters related to HIV infection based on state-of-the-art methods, and choice of end-points. For previously funded preclinical groups: evidence of significant progress in the previous award (e.g. design, formulation, or development of therapeutic entities/strategies that merit clinical evaluation). 4. The Principal Investigator's and Project Leaders' commitment to devote substantial time and effort to the program. [Due to the complexity and time required to maintain a well-coordinated and productive research effort, a minimum 20% (time) commitment by the PI and PLs is strongly suggested unless there are compelling arguments to the contrary.] 5. For groups focusing on preclinical research: o Choice of the therapeutic target or strategy, its contribution to the diversity of potential therapeutics, and the likelihood that the target/strategy can be developed (e.g., following a prescribed preclinical development plan; selecting a clinical candidate compound) during the award period. 6. For groups proposing clinical research: o Adequacy and validity of the proposed milestones for determining the readiness of the group to transition to clinical research; iterative research plan to develop and optimize the proposed strategy; protocol design (clinical and scientific); short and long term development plans; contingency plans addressing the specific objectives; plans to guard the safety of subjects; plans to evaluate outcome even if negative; and provisions to obtain the required institutional and regulatory approvals (IRB, FDA, RAC) to conduct the clinical study. o Experience of the Principal Investigator and Project Leaders in the planning, design, and conduct of small clinical studies in HIV-infected patients; availability of a General Clinical Research (GCRC), Center for AIDS Research (CFAR), or other additional source of institutional support and/or statistical support; the infrastructure required for the conduct of safe and efficient clinical research; and short and long range plans that will result in the successful implementation of clinical studies during the award period. o If a previously funded clinical group: a clinical concept that is new, substantially improved, or that represents a new opportunity/direction resulting from the preceding funding period. 5. In addition to evaluating the scientific merit of the application, all multi-project applications are also assessed for the soundness of the administrative and organizational structure that facilitates attainment of the objective(s) of the program. Thus, the Administrative Core should detail the short and long term management of the Program such as: communication, group meetings, sharing and transmission of information and reagents, awareness of development at other projects within the program, progress, problems and how will they be addressed, engagement of the Scientific Advisory Panel and NIAID in the group's research activities/meeting, consideration and integration of scientific input/recommendation from the Scientific Advisory Panel and NIAID into scientific direction and decision-making, timely reporting as required in the Terms of Award (provided at the time of award), HHS, NIH Office of Biotechnology Activities - Recombinant Advisory Committee (OBA-RAC), and FDA as applicable, and other aspects relevant to the cohesiveness and interactive nature of group activities The initial review group will also examine: the adequacy of plans to include children and both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered when making funding decisions: quality of the proposed project as determined by peer review, overall program balance among research areas of the announcement, balance of preclinical and clinical studies, and availability of funds. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the NIAID brochure INSTRUCTIONS FOR APPLICATIONS FOR MULTI- PROJECT AWARDS http://www.niaid.nih.gov/ncn/grants/multibron.htm. (April 1999) as well as inquiries regarding programmatic (research scope, eligibility and responsiveness) issues may be directed to: Nava Sarver, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Room 4216, MSC 7626 6700-B Rockledge Drive Bethesda, MD 20892-7626 Telephone: 301-496-8197 Fax: 301-402-3211 EMAIL: nsarver@niaid.nih.gov Programmatic issues specific to CNS-related applications may be directed to: Dianne Rausch, Ph.D. Center for Mental Health Research on AIDS National Institute of Mental Health Room 6209 6001 Executive Boulevard, MSC 9619 Bethesda, MD 20892-9619 Telephone: 301-443-7281 Fax: 301-443-9719 EMAIL: dr89b@nih.gov Direct inquiries regarding review to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2148, MSC 7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: 301-496-0818 Fax: 301-402-2638 EMAIL: dtingley@niaid.nih.gov Direct inquiries regarding NIAID fiscal matters to: Ms. Linda Shaw Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2125, MSC 7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: 301-402-6611 Fax: 301-480-3780 EMAIL: shaw@niaid.nih.gov Direct inquiries regarding NIMH fiscal matters to: Ms. Diana S. Trunnell Division of Extramural Activities National Institute of Mental Health Room 7C-08 Parklawn Bldg 5600 Fishers Lane Rockville, MD 20857 Telephone: 301-443-2805 Fax: 301-443-6885 EMAIL: diana_trunnell@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance No. 93.856. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or, in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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