PAR-98-043: CENTERS FOR AIDS RESEARCH (CFARS)

Department of Health
and Human Services (HHS)

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CENTERS FOR AIDS RESEARCH (CFARs) Release Date: March 20, 1998 PA NUMBER: PAR-98-043 P.T. National Institute of Allergy and Infectious Diseases National Cancer Institute National Heart, Lung and Blood Institute National Institute of Child Health and Human Development National Institute on Drug Abuse National Institute of Mental Health Pre-Application Conference Date: April 6 Letter of Intent Receipt Date: April 17 Application Receipt Date: May 14 PURPOSE This program announcement replaces PAR-97-027 published in the NIH Guide, Vol. 26, No. 3, January 31, 1997. Participating Institutes of the National Institutes of Health (NIH) invite applications for center core grants (P30) to support Centers for AIDS Research (CFARs). CFAR cores provide infrastructure and promote basic, clinical, behavioral and translational AIDS research activities at institutions that receive significant AIDS funding from multiple NIH Institutes or Centers. CFARs foster synergy and improve coordination of research, support emerging research opportunities, and promote economy of scale through resources shared by multiple independent laboratories. CFARs also encourage other activities that serve the requirements of AIDS research. CFARs are not intended to be "Centers of Excellence" in specific areas of AIDS research, but instead are intended to promote all AIDS research efforts at CFAR institutions. Before preparing an application to support a CFAR, investigators are urged to consult with the program staff listed under INQUIRIES. DEFINITIONS Throughout this program announcement P30 applications to support CFARs are abbreviated as "CFAR applications" and the corresponding P30 awards to support CFARs are abbreviated as "CFAR awards." NIH CFAR awards support administrative, developmental, basic science and clinical science cores for AIDS research. AIDS research and AIDS-related research are abbreviated as "AIDS 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. This program announcement (PA), CENTERS FOR AIDS RESEARCH, 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 Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or Local Government, and eligible agencies of the Federal Government. Foreign institutions are not eligible to apply, but CFAR cores may be located at foreign sites. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. o One CFAR award per Institution. No institution will receive more than one CFAR award. Institutions that have significant overlap in faculty, resources or administration should submit only one application. Independent campuses that are part of a large multiple city university are considered to be separate institutions. Applicants may contact program staff listed under "Inquiries" for additional guidance. o Multi-Institutional CFARs. Two or more institutions that can demonstrate a credible plan for collaborative research networks using CFAR cores may submit an application for a single CFAR award involving multiple institutions. A multi- institutional CFAR application must designate a prime institution that will receive the award and provide details of agreements regarding coordination and support of cores and activities at other participating institutions. With appropriate justification, CFAR awards may support a core at a distant site, including a foreign site, that provides a unique resource such as a primate facility or a high resolution NMR facility. To achieve administrative efficiency and foster a sense of community and collaboration, it is expected that each unique resource would serve as a core for only a single CFAR, and that all cores within any single institution would be part of the same CFAR award. o NIH AIDS Funded Research Base. The purpose of CFARs is to support the AIDS research activities of investigators at applicant institution(s) that have significant NIH funding for AIDS research (NIH AIDS funded research base). The NIH AIDS funded research base includes the total cost of research awards and the number of these awards to investigators participating in the CFAR. The research base includes peer-reviewed AIDS grants, cooperative agreements, and research contracts utilizing only the following mechanisms: P01, R01, R03, R21, R29, R35, R37, U01, U10, U19, and K series awards, R18, and N01 (excluding contracts that primarily fund the production of materials or services for support of research). Excluded from the NIH AIDS funded research base are all funds from any source other than NIH. Multi-institutional CFAR applications may combine the NIH AIDS funded research of the investigators participating in the proposed CFAR to meet the funding policies of participating Institutes described below. o Funding Policies of Participating Institutes. CFAR awards are intended to support AIDS research activities for applicants who receive significant NIH AIDS funds. Significant NIH AIDS funds are defined as an NIH AIDS Funded Research Base in excess of $6 million in annual total cost for the NIH fiscal year (October 1 to September 30) preceding receipt of CFAR applications. A CFAR award may include funds from multiple NIH Institutes. Usually, an Institute will contribute to a CFAR award only when that Institute has provided active AIDS awards totaling more than $1 million in annual cost to three or more principal investigators who agree to participate in the CFAR. Generally, the maximum amount of funds from each Institute will be 10% of the amount received by the applicant from that Institute for AIDS research as reported by the Office of AIDS Research for the NIH fiscal year preceding receipt of CFAR applications. The actual amount of funds will be influenced by the potential synergy and collaboration with Institute-supported investigators demonstrated by the CFAR application and the percent of Institute-supported AIDS investigators who agree to participate in the CFAR. NIH will provide applicants with a spreadsheet (Excel) indicating all investigators receiving NIH AIDS funding at an applicant(s) institution, organized by NIH funding Institute. Applicants should indicate those investigators who have formally agreed to participate in the CFAR. Review committees are interested in why investigators listed in the spreadsheet chose not to be part of the CFAR. For example, they may have moved or may no longer be involved in AIDS-related research. Applicants may also delineate investigators at their institution(s) who will be part of the CFAR but who were not included in the spreadsheet. For example, they may have recently moved to the institution(s) or have recently become involved in AIDS-related research. It is important that the CFAR be inclusive of the full range of AIDS science funded at a given institution so the inquiry into inclusion or not of a given investigator is also intended to address this issue. A CFAR award (total cost) will be limited to 10% of the amount of funds received by the applicant for AIDS funding as reported by the Office of AIDS Research for the NIH fiscal year preceding receipt of the application. Also, no CFAR award will exceed $1.5 million annually and no participating NIH Institute will provide more than $1.2 million for any one award. o Applications over $500,000. NIH Institutes participating in this CFAR program announcement have agreed to co-fund successful applicants through a review and award process administered by the NIAID. Applicants planning to submit a CFAR application requesting $500,000 or more in direct costs in any year are advised that it is important that they contact program staff listed as they begin to develop plans. Applicants should contact Dr. Janet Young at the address listed under "Inquiries" for guidance. Applications received without prior staff contact may be delayed in the review process or returned to the applicant without review (NIH GUIDE, Volume 22, Number 45, December 17, 1993). MECHANISM OF SUPPORT The mechanism of support will be the Center Core Grant (P30). Responsibility for the planning, direction and execution of the proposed project will be solely that of the applicant. The total requested project period may not exceed five years and applicants are encouraged to apply for five years. However, applicants are notified that grants may be awarded for three, four, or five years. RESEARCH OBJECTIVES Background The NIAID CFAR program was established in 1988 and was renewed in 1993. The mission of the CFAR program and mechanisms for achieving this mission were developed with the assistance of CFAR directors in 1995 and revised in 1996. The mission of the CFARs is to support a multi-disciplinary environment that promotes basic, clinical, behavioral, and translational research in the prevention, detection, and treatment of HIV infection and AIDS. The CFARs accomplish this mission by: o Providing scientific leadership dedicated to AIDS research. o Providing institutional infrastructure dedicated to AIDS research. o Stimulating scientific collaboration and translational research. o Fostering scientific communication. o Sponsoring training and education. o Promoting knowledge of CFAR research findings and the importance of AIDS research through community outreach. o Facilitating development of AIDS therapeutics, vaccines and diagnostics through promotion of scientific interactions between CFARs and industry. Objectives and Scope CFARs should promote and encourage activities that enhance collaboration and coordination of AIDS research and serve the requirements of all AIDS investigators at the applicant institutions regardless of funding source. CFAR awards support four different types of cores: administrative, developmental, basic science, and clinical studies. Each CFAR should have a single administrative and a single developmental core, and a number of basic and clinical science cores selected to support optimally the AIDS research at the applicant institution(s). The smallest CFAR would consist of one of each type of core. The definition of what constitutes a basic or clinical core should be considered sufficiently broad to meet the needs of the applicant institution(s) and may vary among CFAR applicants. For example, epidemiology, biostatistics, and behavioral cores could be classified as either basic or clinical cores. The successful management of AIDS resources with minimal CFAR funding is an important measure of a CFAR"s value to AIDS investigators. Basic and clinical cores may be supported totally by CFAR funds, only in part by CFAR funds, or not at all by CFAR funds. Applicants are encouraged to develop creative collaborations to improve utilization of existing resources. Convincing justification will be necessary for duplication of any basic or clinical core that exists in a similar form elsewhere in the applicant institution(s). Applicants should describe how cores with partial or no CFAR funding will be used to enhance the research of CFAR investigators. For example, a CFAR core supported by other funding (e.g., an NIAID AIDS Clinical Trial Unit or a NCI core facility) may become more accessible to AIDS investigators through CFAR association and coordination. A CFAR has considerable flexibility within its budget to alter funding of a basic or clinical core, to delete a core, or to initiate a new core. Policies should be described for changes in CFAR funding levels of initially proposed cores and for the establishment of new cores as needed to meet research needs without additional funding. Applicants should describe how the proposed policies protect and incorporate the divergent needs of CFAR investigators. An applicant"s initial choice of basic and clinical cores is an important measure of the management process. Applicants should describe the basic and clinical cores to be supported at the time that the CFAR is awarded, how this choice of cores was selected, other potential cores that were evaluated but not selected, mechanisms for evaluating utilization of proposed cores, and criteria for increased or decreased funding of these cores during the course of award. Cores should be responsive to the needs of AIDS investigators at the applicant institution(s). Applicants should describe in detail the operation of the each core (quality control, procedures, safety, training, etc.). Applicants are encouraged to contact program staff listed under "Inquiries" to discuss the choice of cores they are planning. In making final funding decisions for CFAR support, individual NIH Institutes direct considerable attention to how the CFARs address and plan to address programmatic areas of interest to the involved funding Institutes. A CFAR has the responsibility to use its resources in the best manner to meet the needs of its investigators and the authority to alter allocation of resources within the guidelines of the CFARs operating policies and procedures. Applicants should describe how proposed policies and procedures provide oversight for different types or levels of decisions and how each of the following individuals or groups would participate in the decision process: a core director, the CFAR director, an internal advisory board, CFAR investigators, an external advisory board, NIH program staff. Additional CFAR supported activities are encouraged. Examples include industry collaborations, development of minority scientists in AIDS research, AIDS research communications to non-scientists, addressing problems in enrollment and retention of women and minority groups in AIDS clinical trials, international collaborations, and other activities that meet the AIDS research needs of applicant institutions. Applicants may wish to contact program staff to discuss the types of cores and additional activities they are considering. Commitments for continued funding in the non-competitive continuation years of all NIH grants are dependent upon the availability of funds. CFAR awards that receive co-funding from multiple Institutes may encounter decreased funding if any of these Institutes decreases their funding commitment. Therefore, applicants should describe policies and processes for CFAR "down-sizing" decisions should decreased funding be necessary in continuation years. o Administrative core. The administrative core is led by a CFAR director (P30 grant"s principal investigator) who should be a recognized leader in the field of AIDS research. The administrative core also may require a senior administrator, a CFAR office that is a clearly separate entity, and a modest staff for support of CFAR activities. The responsibilities and time allocation of each staff person and the proposed operation procedures for the administrative core should be described in detail. The administrative core is responsible for the management of all CFAR activities. The administrative core section of the CFAR application should contain a separate section describing the strategic plan and a separate section on policies and procedures for the first year of operation. Both of these sections will be incorporated by reference into Terms and Conditions of Award. Strategic plan. The purpose of the strategic plan is to identify the most significant opportunities and gaps in science that will be addressed by the CFAR in the short and long term and to identify objective milestones to measure success or failure. The following process and organization is suggested for the strategic plan: o Strengths - Describe the strengths of the CFAR including a summary of research of CFAR participants and the current facilities and resources available. Outline the major AIDS studies to be supported by the CFAR. Organize by studies related to the mission of the relevant co-funding Institutes (one page or less is suggested per funding Institute). Cite grant numbers listed in the Excel table showing the NIH AIDS funded research base of the institution(s). o Opportunities - Identify and evaluate all potential opportunities for use of CFAR funds. This analysis will probably require outreach for suggestions from all potential CFAR participants. Conduct a cost/benefit analyses to determine which opportunities both utilize the applicants unique strengths and address the missions of funding Institutes. o Action Plan - Choose the highest priority opportunities and develop a detailed plan for the first year of funding. Examples of an action plan include determining which cores will be established, determining how existing cohorts will be utilized, identifying the categories of support for developmental projects, communication and outreach, and identifying the lectures and meetings the CFAR will sponsor. o Outcome Measurements - Determine how progress on action plans will be measured. Select long-term goals and annual milestones for the first year. In addition to other items, place information about any advisory committees under the administrative core. Describe membership of all committees, how participants were selected, terms of appointment, authority and responsibility of members. The ability to manage the CFAR award will be judged by the clarity and thoughtfulness of the administrative and developmental core sections of the proposal, and evidence of the selection and organization of additional cores through acquisition of information, support, and participation of the AIDS investigators at the applicant institution(s). Policies and Procedures. Policies should be considered to be "a set of guiding principles of operation. There are no "correct" policies and different CFARs may adopt different polices. Below are several non-inclusive examples of justifiable but not necessarily compatible policies that might be used to address funding issues. Funding issues are an example of only one area that the CFAR will consider in the development of policies and procedures. o CFAR funding will be allocated to disciplines in proportion to research in those disciplines. o CFAR funding will be allocated to projects based on a majority vote of all CFAR members. o CFAR funding will be allocated to projects based on majority vote of an internal advisory board. Procedures should be considered to be a set of established actions to conduct the affairs of the CFAR. Procedures should specify specifically how various tasks will be accomplished within the policy guidelines of the CFAR. The policies and procedures should describe: o The proposed roles in decision processes of the CFAR director, core directors, CFAR investigators, advisory boards, institutional officials, and NIH program staff. o The annual strategic planning process, how funds will be allocated to all types of cores and activities, procedures for changes in support of any cores, how CFAR-sponsored conferences, seminars, workshops, and other activities will be identified, how priorities for communication, outreach and additional CFAR activities will be established, how cores, core directors, leaders of additional CFAR activities, internal and external advisory committees will be selected and evaluated, the authority and responsibility of internal and external advisory committees, how developmental projects are selected and evaluated, how cores are selected and reports to be developed, including the annual strategic plan and the noncompetitive renewal. o The mechanisms used to determine AIDS research basic core needs at the applicant institution(s), assign priorities to potential cores, and select the basic cores that are included in the application. o The mechanisms used to determine AIDS research clinical core needs at the applicant institution(s), to assign priorities to potential cores, and to select the clinical cores that are included in the application. o Developmental Core. The intent of a CFAR developmental core is to support scientific studies for short periods of time to develop preliminary data for peer-reviewed research applications. Four general areas are eligible for support as developmental awards: investigators new to AIDS research who have not previously received R01-type awards in AIDS research, feasibility studies, emerging research opportunities and AIDS research activities of newly recruited faculty. Applicants may wish to consult with the program staff listed under INQUIRIES to discuss how developmental cores are used at current CFARs. The CFAR administrative core should establish the mechanisms for allocation of developmental funds and for annual evaluation of supported activities. CFAR applicants should describe the mechanism to be used for identification, peer- reviewed selection and outcome evaluation of projects supported by the developmental core. Applicants who have current CFARs should describe outcome evaluation of previously funded developmental projects. The developmental core section should contain a plan for the use of the first year developmental funds. o Basic Science Cores. Basic science cores support shared research activities that cannot easily be funded through standard research granting mechanisms. Basic science cores should provide economy of scale through use by multiple laboratories and foster collaboration between basic and clinical investigators. Basic science cores should not substitute for resources that are obtainable commercially or replace existing resources normally supported by individual research grants. CFAR applications should describe the mechanisms used to determine AIDS research basic core needs at the applicant institution(s), assign priorities to potential cores, and select the basic cores that are included in the application. CFAR applications should describe the basic science cores to be supported at the time of the award and any changes anticipated during the course of the award. A basic science core should be designed to support multiple AIDS investigators and applicants should indicate the anticipated users and the percent time of use by each. Mechanisms should be described to select users, evaluate annual use, and justify level of continued CFAR support in comparison with other AIDS research needs at the applicant institution(s). o Clinical Cores. Clinical cores should provide the resources for AIDS translational research collaboration between clinical and basic scientists. Activities that will not be supported by a CFAR clinical core are normal patient care including screening of clinical specimens, diagnosis, treatment or rehabilitation. CFAR applications should describe the mechanisms used to determine AIDS research clinical core needs at the applicant institution(s), to assign priorities to potential cores, and to select the clinical cores that are included in the application. Mechanisms should be described to select users, to evaluate annual use, and to justify level of continued CFAR support in comparison with other AIDS research needs at the applicant institution(s). o Institutional Commitment. Institutional commitment is particularly important for the coordination of resources across the broad areas and potential boundaries of research supported by the co-funding Institutes. Provide a letter(s) from the appropriate institutional official(s) (e.g., Dean, President, or Provost) defining: - Position, authority, and reporting responsibility (on institution"s organizational chart) for the CFAR director. - Financial and other resource support for the CFAR that will be provided by the applicant institution(s). - Authority or influence that the CFAR director has over other AIDS projects, facilities and space, decisions on new faculty and support personnel. CFAR BUDGET ITEMS o Percent Effort. The percent effort requested should be limited to time devoted specifically to managing CFAR activities and not to research activities. The effort devoted to CFAR activities should not be that which would normally be supported by research grants. Information documenting the level of effort on CFAR activities must be included in the application. The need for all requested personnel costs should be thoroughly justified. The percent effort of the CFAR director should be justified with the director"s other responsibilities. Administrative support (a secretary or an administrative assistant) should be requested for the CFAR office only for matters directly pertaining to the CFAR. Core directors are CFAR members who are responsible for the overall technical excellence of a core facility. The CFAR supported percent effort of core directors involved in research activities should only include core management time. The CFAR may support technical staff to provide CFAR services in core facilities. Salary support using developmental core funds should only be used for junior faculty. Established investigators with R01-type grants are expected to have salary support from other sources. o Core Budgets. Core budgets may include equipment, supplies, support contracts, and other necessary expenses. All items should be fully justified for allocation of CFAR funds. o Other Administrative Costs. This category includes the costs necessary for the central administration and fiscal management of the CFAR, including relevant and reasonable costs for reprints, graphics, and publications for developmental core users. o Travel. CFAR directors" meeting(s) - The CFAR directors and one senior scientist per center will meet two times per year, at the NIH, at a CFAR site or at the site of a scientific conference that most of the directors plan to attend. Applicants should include travel funds specifically for these meetings in the CFAR administrative core budget request. For budget purposes, applicants may assume a total annual cost for the CFAR directors meeting of $5000. Other Travel - Applicants may request and justify travel funds in addition to the funds required for the two directors" meetings. These funds should not be used for travel to scientific meetings. For example, this travel could promote collaboration among CFAR investigators and AIDS investigators not in a CFAR program or at distant cores. These additional travel funds should not exceed $5000. 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). 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 in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may obtain copies from these sources or from Dr. Young (listed in INQUIRIES below) who may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by April 17, 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 this program announcement. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows staff to estimate the potential review workload and to help avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Janet Young at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are strongly encouraged to contact program staff early in application development with any questions regarding the responsiveness of their application to the goals of this PA. Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted only once each year on the annual receipt date. 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, Tel: (301) 435-0714, email: asknih@od.nih.gov. Page limitations. Page limitations have been increased from the normal 25 page limit for sections A-D of the "Research Plan" of an application. For applications in response to this program announcement, the page limitation has been increased to 300 pages for the entire CFAR application excluding only appendices. Please note that appendices will only be provided to the primary reviewers. Appendices should not contain information required for review by other committee members. The 300 page limit is a maximum and applicants are encouraged to be concise. Organization of Application In order to facilitate the review process, applicants should follow the instructions described in "Special Instructions for Preparation of the CFAR Application." The Special Instructions provides information on how to organize and present information in the CFAR application to facilitate review and award. The CFAR web site includes the Special Instructions and the CFAR Program Announcement: http://www.niaid.nih.gov/cfarpa.htm Hard copies of both documents may be obtained from the Program Staff listed under INQUIRIES. Applications must be mailed to both the NIH Center for Scientific Review and to the NIAID Division of Extramural activities. For purposes of identification and processing, item 2 on the face page of the application must be marked "YES". Also, the PA number and title, CENTERS FOR AIDS RESEARCH (CFAR), of this program announcement must be typed in Item 2. The completed signed original application and three single sided copies of the application must be sent or delivered 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/courier service) Two single-sided copies of the application and five copies of appendices must be sent or delivered to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C07 Bethesda, MD 20892- MSC 7610 Telephone: (301) 496-2550 FAX: (301) 402-2638 Email: dt15g@nih.gov REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the NIH Center for Scientific Review and for responsiveness to the goals of this PA by NIAID staff in consultation with the other co-funding Institutes. Incomplete or non- responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated for scientific and technical merit by an Initial Review Group (IRG) of NIAID. As part of the initial merit review, all applications will receive a written critique, assigned a priority score, and receive a second level review by an appropriate national advisory council(s) or board(s). Review criteria Review criteria are based on the mission of the CFAR Program and mechanisms for achieving this mission. The initial review group (IRG) will evaluate CFAR applications for significance, approach, innovation, investigator, and environment. In these evaluations, the IRG will also look for evidence of successful performance from applicants that have had CFAR awards or similar programs at their institutions. The organizational structure of sections of a CFAR application resembles that of an R01 application: CFAR Application R01 Application Strengths Background Opportunities Significance Action Plan and Outcome Measurements Specific Aims Policies and Procedures Materials and Methods Choice of Cores and their Operating Structures Preliminary Results for new applications Progress Report for renewal applications The NIH review criteria have been adapted to ensure that the major components of a CFAR application are evaluated appropriately. The score should reflect the overall impact that the project could have on the field based on consideration of the five criteria, with the emphasis on each criterion varying from one application to another, depending on the nature of the application and its relative strengths. Note that an application need not be strong in all categories to be judged likely to have 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. The review criteria are: Significance - The effect that a CFAR award would have on an applicant"s AIDS research efforts. 1. The ability of cores to support the research base, foster synergy, coordinate AIDS research collaborations and produce an economy of scale. 2. Proposed scientific communication, outreach, training efforts, and collaborations with industry and evidence that CFAR will enhance these collaborations. 3. Developmental core procedures for selection of projects and outcomes evaluation. Approach - The quality of the CFAR planning and management process. 4. Annual strategic planning process. 5. Policy and procedures to judge value of cores and reassign funding priorities. 6. Methods for selection of basic and clinical core users and for prioritization of use. Innovation - The utilization of CFAR resources in unique ways to achieve the scientific goals of all AIDS investigators at the participating institution(s). 7. The degree of variety in AIDS research projects and disciplines that commit to participation in and coordination through the CFAR structure. 8. The incorporation into the CFAR of resources (cores, projects, cohorts, trials, etc.) that are supported in part or not at all by CFAR funds. Investigator - The choice of appropriate leaders to carry out the CFAR mission. 9. Choice of CFAR director, e.g., managerial experience, commitment, leadership in AIDS research and at the applicant institution. 10. Choice of core directors and key personnel, e.g., qualifications, competence and commitment. 11. Proposed advisory groups: their responsibility and methods for their selection. Environment -- The likelihood that a CFAR will achieve its objectives. 12. Institutional commitment including space, institutional financial support and other institutional resources and oversight provided for CFAR activities. 13. Previous history of support for developmental projects that have successful outcomes. 14. Appropriateness of budget of the overall CFAR and of the individual cores. In addition, applicants must demonstrate adequate 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 Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review. o Availability of funds. o Institute"s priority for area of proposed research. CONDITIONS OF AWARD The Conditions of Award will incorporate the following items proposed by the applicant with potential modifications based on recommendations of the Initial Review Committee: CFAR Strategic Plan. CFAR Policies and Procedures. CFAR Advisory Committee(s) authority and responsibility. Any changes in these items from the Notice of Award will require concurrence of NIH. INQUIRIES The opportunity to clarify any issues or questions regarding CFARs or CFAR applications is welcome. Especially encouraged are inquiries through the CFAR web site: http://www.niaid.nih.gov/cfarpa.htm In addition to submitting inquiries at this web site, applicants may view inquiries by others, read the official NIH responses, and obtain suggestions for application organization. Questions regarding CFAR scientific issues, management issues, or issues on cores related to NIAID may be directed to: Janet M. Young, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C11 - MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 496-6714 FAX: (301) 402-3211 Email: jy6r@nih.gov Questions on review issues may be directed to: Dianne Tingley, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building 6003 Executive Boulevard, Room 4C07, MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-2550 FAX: (301) 402-2638 Email: dt15g@nih.gov Questions on fiscal issues may be directed to: Ms. Pamela Fleming Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C25 - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 402-6580 FAX: (301) 480-3780 Email: pf49e@nih.gov CFAR program staff contacts for other participating Institutes. Questions specifically related to program interests of other Institutes may be directed to: Margaret Holmes, Ph.D. Office of the Deputy Director for Extramural Science National Cancer Institute 6130 Executive Boulevard, Room 502 Rockville, MD 20852 Telephone: (301) 496-8531 FAX: (301) 402-0181 Email: mh67g@nih.gov Elaine Sloand, M.D. AIDS Coordinator National Heart, Lung and Blood Institute 31 Center Drive, Room 4A11, MSC 2490 Bethesda, MD 20892-2490 Telephone: (301) 496-3245 FAX: (301) 594-1290 Email: es38n@nih.gov Anne Willoughby, Ph.D. Pediatrics, Adolescent, and Maternal AIDS Branch National Institute of Child Health and Development 6100 Executive Boulevard, Room B11H Rockville, MD, 20852 Telephone: (301) 496-7339 FAX: (301) 496-8678 Email: aw55g@nih.gov Steven W. Gust, Ph.D. Office on AIDS National Institute on Drug Abuse 5600 Fishers Lane, Room 10-05 Rockville, MD 20857 Telephone: (301) 443-6480 FAX: (301) 443-4100 Email: sgust@nih.gov Dianne Rausch, Ph.D. Office of AIDS Research National Institute of Mental Health 5600 Fishers Lane, Room 18-105 Rockville, MD 20857 Telephone: (301) 443-7281 FAX: (301) 443-7274 Email: dr89b@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, 93.856 - Microbiology and Infectious Diseases Research and 93.855 - Immunology, Allergy and Transplantation 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 grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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