CENTERS FOR AIDS RESEARCH: D-CFAR, CFAR RELEASE DATE: March 27, 2003 PA NUMBER: PAR-03-089 (This document has been reissued as PAR-06-291, see amendment, NOT-AI-05-036) Receipt Date: June 16, 2003, June 16, 2004, and June 16, 2005 EXPIRATION DATE: June 17, 2005, unless reissued. National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) Fogarty International Center (FIC) (http://www.fic.nih.gov/) National Cancer Institute (NCI) (http://www.nci.nih.gov) National Center for Complementary and Alternative Medicine (NCCAM) (http://www.nccam.nih.gov/) National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov) National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov/) CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: No. 93.213, Research and Training in Complementary and Alternative Medicine No. 93.242, Mental Health Research Grants No. 93.279, Drug Abuse Research Programs No. 93.393, Cancer Cause and Prevention Research No. 93.394, Cancer Detection and Diagnosis Research No. 93.396, Cancer Biology Research No. 93.839, Blood Diseases and Resources Research No. 93.855, Immunology, Allergy, and Transplantation Research No. 93.856, Microbiology and Infectious Diseases Research No. 93.864, Population Research No. 93.865, Center for Research for Mothers and Children No. 93.989, Senior International Fellowships THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Terms and Conditions of Award o Required Federal Citations PURPOSE OF THIS PA This program announcement replaces PAR-00-054 published in the NIH Guide, February 9, 2000. Participating Institutes of the National Institutes of Health (NIH) invite applications for center core grants (P30) to support Centers for AIDS Research: standard CFARs (CFAR) and Developmental CFARs (D-CFAR). 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 and D-CFARs are intended to promote all AIDS research efforts at CFAR institutions. D-CFARs provide modest support for a limited period to assist investigators in the development of a competitive CFAR. Additionally, this announcement defines a process for CFAR competitive supplements. Before preparing an application to support a CFAR, investigators are urged to consult with the program staff listed under "Inquiries." NIH Support of Research on this Topic While this Program Announcement is being issued by FIC, NCI, NCCAM, NHLBI, NIAID, NICHD, NIDA, and NIMH, the other components of NIH listed below also have an interest in and support research on the topics covered. Applicants may wish to contact each of these NIH components listed in INQUIRIES to find out about other funding opportunities. Institutes and Centers at NIH use different grant mechanisms to support their portfolios of research; the components listed here may not use all of the mechanisms specified for this Program Announcement. National Center for Research Resources (NCRR) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Applications submitted in response to Program Announcements are assigned according to established PHS referral guidelines. When the subject of an application is of interest to more than one component of NIH, dual assignments are made. 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." "Core" or "core facilities" are defined as entities providing services or expertise to be shared by multiple independent laboratories. 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." ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. A. Comparison of the two CFAR awards This program announcement describes two types of CFAR awards. The first is for a Developmental CFAR (D-CFAR) for AIDS investigators at an institution that is eligible, but does not yet have a CFAR. The D-CFAR will provide the support necessary to develop a collaborative network that may permit the institution to be more competitive for a standard CFAR award. The second type of award is for a standard CFAR (CFAR). Both the D-CFAR and the CFAR are funded through the P30 mechanism for infrastructure development. This PA describes requirements for both types of CFARs. Sections for the D-CFAR describe characteristics unique to this award. B. NIH AIDS Funded Research Base To be eligible for a CFAR award, an institution must have a significant research base. A significant NIH AIDS funded research base (FRB) is defined as: the funding level, in annual total cost for the NIH fiscal year (October 1 to September 30), preceding receipt of CFAR applications. The research base includes peer-reviewed AIDS grants, cooperative agreements, and research contracts utilizing only the following mechanisms: P01, R01, R03, R18, R21, R24, R29, R33, R35, R37, U01, U10, U19, U24, U54, and K series awards, 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. For the D-CFAR and CFAR awards, a FRB in excess of $6 million is required. Below is a comparison table of the D-CFAR and CFAR awards. D-CFAR CFAR FRB/BASE FUNDING >6M/$750K Total Cost $6-40M/$1.5M Total Cost $40-80M/$2.25M >$80M/$3M FUNDING PERIOD 3 years 5 years COMPETITIVE RENEWAL Not allowed Allowed FOCUS Become competitive Support all NIH AIDS for a standard CFAR investigators at institution C. Funds available D-CFAR: Maximum funding level, or base funding of a D-CFAR is limited to requests for 10% of the FRB as reported by the OAR spreadsheet for the NIH fiscal year preceding receipt of the application, up to $750,000 total cost. CFAR: For institutions with a FRB of $6M to $40M, a CFAR award (Total Cost) will be limited to 10% of the FRB, up to $1.5M, total cost. For institutions with a FRB of $40M to $80M, a CFAR award will be a base of $2.25M, total cost. For institutions with a FRB that is greater than $80M, a CFAR award will be a base of $3M total cost. Recompeting CFARs will be limited to an inflationary increase beyond the total cost funding level of the current grant, unless the FRB decreases, in which case the following conditions apply: If the FRB of a recompeting CFAR is below $15 million, the applicant is limited to requesting 10% of the FRB. If the FRB of a recompeting CFAR is $15-40M, the applicant is limited to requesting $1.5M. If the FRB of a recompeting CFAR is $40-80M, the applicant is limited to requesting a funding level of $2.25M. CFARs that successfully recompeted for renewal in 2003, and that have a funded research base that is greater than $40M or greater than $80M, will be eligible to submit a complete revised proposal and budget request to increase the CFAR base funding to $2.25M total funds, and $3M total funds, respectively, for years 2 through 5 of the award. This will be a one-time allowance in the first year of this program announcement. Reviewers will evaluate the revised request as it relates to the recently funded program, but will not specifically review the recently funded program. Should the new proposal not receive a fundable score, the CFAR will retain the existing budget until the entire CFAR submits a competitive renewal application. D. 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 are encouraged to contact program staff listed under "Inquiries" for additional guidance. E. Guidelines for multi-institutional CFARs In some cases, two or more institutions that can demonstrate a credible plan for collaborative research networks using CFAR cores may wish to submit an application for a single CFAR award. Reviewers will look critically at the request for multi-institutional applications for the following indicators: a demonstration of exceptional need to establish a collaboration between investigators at separate institutions; evidence of unique plans, such as the development of organized communications systems, to overcome the scientific and management challenges that are naturally a part of multi-institutional collaborations; specific plans to address anticipated budgetary problems in the transfer of funds and resources from one institution to another; and evidence for centralized authority of the CFAR Director for the purpose of management of the CFAR facilities at other sites. Multi-institutional CFAR applications may combine the NIH AIDS funded research of all the investigators at the institutions participating in the proposed CFAR to meet the NIH AIDS Funded Research Base requirement. CFARs that use a distant institution for a core facility, but are not including all of the NIH AIDS investigators at that institution as part of the CFAR may not use the Funded Research Base of any single investigator at that institution. A CFAR cannot use the FRB of an institution that is already part of another CFAR. A multi-institutional CFAR application must designate a lead institution that will receive the award and provide details of agreements regarding coordination and support of cores and activities at other participating institutions. F. Cores outside of the CFAR institution With appropriate justification, CFAR awards may support a core at an institution that is not part of the CFAR, including a foreign institution that provides a unique resource such as a clinical site, or a primate facility. NIH AIDS funding of the investigators at this core facility is not included as part of the FRB of the CFAR (see Funded Research Base). G. Funding for CFARs from multiple NIH Institutes CFARs will be awarded and administered by NIAID. However, a CFAR award will consist of funds from multiple NIH Institutes. Management oversight of the CFAR grants will be provided through an NIH CFAR Steering Committee composed of representatives from the co-funding NIH Institutes and Centers, and from the Office of AIDS Research (OAR). It is therefore suggested that the applicant contact the program representatives listed under 'Inquires' to discuss general CFAR issues, and how CFARs can enhance the AIDS research mission of the NIH Institutes. H. CFAR support for all NIH AIDS investigators NIH will provide applicants with a spreadsheet (Excel) prepared by the Office of AIDS Research (OAR) indicating all investigators receiving NIH AIDS funding at an applicant(s) institution, arranged by NIH funding Institute. Applicants should indicate, in the spreadsheet, those investigators who have formally agreed to participate in the CFAR, and the primary type of participation expected (e.g., attendance at seminars, use of virology core, Developmental Core director, etc.) and include this spreadsheet in their application. See section E, Administrative Core, for more detail on CFAR support of all investigators. It is important that the CFAR be inclusive of the full range of AIDS science funded at a given institution. Therefore, review committees will be interested in why some investigators listed in the spreadsheet chose not to be part of the CFAR. Applicants may also indicate investigators at their institution(s) who will become part of the CFAR but who were not included in the spreadsheet. The reason for inclusion, or exclusion, of a given investigator should be addressed. RESEARCH OBJECTIVES - ALL CFAR AWARDS Note that the following applies to all types of CFAR awards. Following this section is information concerning research objectives that are specific for the D-CFAR. Background The CFAR program was established in 1988 and was renewed in 1993, 1997, and 2000. In May 1999, an ad hoc external review committee convened by the Office of AIDS Research reviewed the CFAR program. Suggestions of the review committee remain incorporated into this program announcement. The mission of the CFAR program and mechanisms for achieving this mission were developed by the CFAR directors in 1995 and revised in 1996, 1998, and in the 2002 Position Statement of the NIH CFAR Directors. The mission of the CFARs is to support a multi-disciplinary environment that promotes basic, clinical, epidemiological, behavioral, and translational research in the prevention, detection, and treatment of HIV infection and AIDS. The CFARs accomplish this mission by: a. Providing scientific leadership and institutional infrastructure dedicated to AIDS research b. Stimulating scientific collaboration in interdisciplinary and translational research c. Strengthening capacity for HIV/AIDS research in developing countries d. Fostering scientific communication e. Sponsoring training and education f. Promoting knowledge of CFAR research findings and the importance of AIDS research through community outreach g. Promoting and supporting innovative NIH HIV/AIDS research initiatives h. Establishing collaborative research between CFARs, and supporting HIV/AIDS research networks i. Facilitating technology transfer and development through promotion of scientific interactions between CFARs and industry j. Supporting research on prevention and treatment of HIV infection in hard- to-reach populations, especially in inner city, rural poor, and disadvantaged minorities A. CFAR added value CFARs should provide added value to the institution's AIDS research efforts through support of activities that cannot easily be provided by standard research grants. For example, CFARs promote and encourage activities that enhance collaboration and coordination of AIDS research. CFARs promote translational research activities, i.e., studies bringing findings of the laboratory to the clinic, and vice versa. Measures of added value include, but are not limited to: Developmental Core awards resulting in collaborations, publications, or funding of R01-type applications; interdisciplinary publications; evidence of CFAR enhancement of existing programs at the institution; the number of clinical protocols started within the institution; patent applications filed or issued; and institutional support for activities previously supported by the CFAR. For recompeting CFARs, Table (2) is provided on the CFAR web site (http://www.niaid.nih.gov/research/cfar/cfarpa.htm), and should be used by the applicant to demonstrate various translational research activities. The activities shown as examples are not meant to be all-inclusive. B. CFARs should serve the requirements of all NIH-funded AIDS investigators at the applicant institutions Cores should address the needs of AIDS investigators at the applicant institution(s). Successful CFARs have accomplished this goal. Applicants should describe in detail the operation of each core (quality control, procedures, safety, training, etc.) and how the proposed policies and procedures protect and incorporate the divergent needs of CFAR investigators. Please see additional details concerning policies and procedures under "Administrative Core". Applicants are encouraged to contact program staff listed under "Inquiries" to discuss strategies being planned for how the CFAR will foster collaboration among AIDS investigators from divergent disciplines. Applicants for recompeting CFARs should describe how different NIH-funded AIDS programs, if funded at the institution, participate in the CFAR. Specific programs funded by the co-funding institutes are listed under "Administrative Core". C. CFARs have scientific and fiscal flexibility A CFAR has the responsibility to use its resources in the best manner to meet the needs of its investigators. A CFAR has the authority to change allocation of resources according to the guidelines of CFAR operating policies and procedures. Applicants should describe how proposed policies and procedures provide structure for decision-making on several levels, and how each of the following individuals or groups would participate in the decision process: core director, CFAR director, internal advisory board, CFAR investigators, and external advisory board. Applicants should also state the process for informing NIH of major changes in the CFAR. A CFAR has considerable flexibility and authority to alter funding of a basic or Clinical Core, to delete a core, or to initiate a new core. Applicants should state what policies and procedures will be used as the basis for reallocation of initial core funding to permit the establishment of new cores, as needed, without additional funding. The extent to which CFAR funding may leverage other resources in support of AIDS research is an important measure of a CFAR's value to AIDS investigators. Basic and Clinical Cores may be supported totally, or in part 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 CFAR funding will be used to enhance the research of CFAR investigators. For example, a CFAR core supported by other funding (e.g., a NIAID AIDS Clinical Trial Unit or an NCI Cancer Center core facility) may become more accessible to AIDS investigators through CFAR association and coordination. Commitments for continued funding in the non-competitive continuation years of all NIH grants are dependent upon the availability of funds. Applicants should describe policies and procedures for CFAR "down- sizing" decisions if there is decreased funding for continuation years. Responsible management includes annual reporting of progress. The NIH has developed guidelines that specify the kind of information it needs in order to answer questions about the program that come from various constituencies, including Congress. The NIH will assess previous progress reports submitted by recompeting applicants, as well as additional responses to requests for information. Results of this assessment will be made available to the applicant and to reviewers of the competitive renewal. Assessments will reflect general trends during the funding period, rather than a single outstanding or insufficient response. D. Additional CFAR-supported activities CFARs traditionally use a variety of strategies to achieve the research objectives of the award. Examples include industry collaborations, community outreach, development of minority scientists in AIDS research, AIDS research communications to non-scientists, approach to problems in enrollment and retention of women and minority groups in AIDS clinical trials, international collaborations, additional support of ongoing NIH programs not planned in the initial award, and other activities that meet the AIDS research needs of applicant institutions. Applicants are encouraged to explore collaborative, multi-institutional linkages with international sites and minority institutions. Such linkages foster international training and collaborative studies and are able to meet needs that cannot be easily addressed by other funding mechanisms. Coordination with international programs funded by the Fogarty Center is strongly encouraged. Contact information for Fogarty programs is provided under "Inquiries". Examples of ways in which current CFARs are able to assist in the development of new investigators, including junior faculty and minority investigators, both domestic and international, are as follows. These examples are not meant to be all-inclusive. 1. Specific mentoring programs for junior faculty that may include guidance in the preparation of developmental core applications, and additional follow- up counseling if the initial application is not funded. 2. Establishment of collaborations between investigators at institutions in the developing world that might include mini-sabbaticals to the CFAR to utilize core facilities, and the mentoring of investigators at the distant site in person, or via computer linkages. 3. Developing specific collaborations with other NIH programs such as the AIDS International Training and Research Program (AITRP) with the Fogarty International Center or the Research Centers in Minority Institutions (RCMI) program with the National Center for Research Resources (NCRR). E. CFAR awards support four different types of cores: administrative, developmental, basic science, and clinical studies: Each CFAR must have a single administrative and a single Developmental Core, and a minimum of one basic and one clinical science core to optimally support the AIDS research at the applicant institution(s). The smallest CFAR would have a minimum of four cores, that would consist of one of each type of core (administrative, developmental, basic, and clinical). The terms basic and Clinical Cores are generic, and the definition of what constitutes a basic or Clinical Core is sufficiently broad to meet the needs of the applicant institution(s), and may vary among CFAR applicants. For example, epidemiology, biostatistics, ethnography, and behavioral cores could be classified as either basic or Clinical Cores, depending on their focus. Clinical Cores will have more direct interaction with patients. An applicant's initial choice of basic and Clinical Cores is an important measure of the science 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 increasing or decreasing funding of these cores during the course of the award. 1. Administrative Core The Administrative Core is responsible for the management of all CFAR activities. 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, and a modest staff for support of CFAR activities. The responsibilities and time allocation of each staff person and the proposed operational procedures for the Administrative Core should be described in detail. The Administrative Core section of the CFAR application should contain separate sections describing the strategic plan, and policies and procedures. Both of these sections will be incorporated by reference into the Terms and Conditions of Award. a) Strategic plan Successful applicants will be required to carry out and report on an ANNUAL strategic planning process to assess current and expected scientific and fiscal needs and planned adjustments, according to the stated policies and procedures. The purpose of the strategic plan is to identify the most significant opportunities and gaps in science at the applicant institution to be addressed by the CFAR in the short and long term, and to identify objective milestones that can measure success or failure. The following process and organization is suggested for the strategic plan: 1) Strengths - Describe the strengths of the CFAR including a summary of research of CFAR participants and the current facilities and resources available. Use Table 4, "Existing Core Facilities at the Institution Applying for a CFAR Award (all applicants) to list all core facilities and those that will be used by the CFAR. This table can be found on the CFAR program announcement web page: (http://www.niaid.nih.gov/research/cfar/cfarpa.htm). Use the column labeled "Participating" in the Excel table showing the NIH AIDS Funded Research Base of the institution(s) to indicate investigators who will, and will not, be participating in the CFAR. Provide a brief explanatory sentence at the bottom of the table for any non-participating. Recompeting applicants should describe how any major AIDS programs at the CFAR institution that are supported by co-funding NIH Institutes are assisted by CFAR. Specific programs are: FIC: AITRP, AIDS FIRCA, ICHORTA-AIDS/TB, and GHRIP NCI: AMC, ACSB NHLBI: CBR NICHD: WHIN, Ad health, REACH NIDA: DARC NIAID: AACTG, PACTG, HPTN, HVTN, CIPRA, IPCP, MACS, WIHS NIMH: Brain Bank, EBAN 2) 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 analysis to determine which opportunities both utilize the applicant's unique strengths and address the missions of NIH funding Institutes. 3) 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. Some CFARs may find that specific thematic areas emerge from this strategic planning process. Development of an action plan that capitalizes on such programmatic themes is encouraged, but not required. 4) Outcome Measurements - Determine how progress on action plans will be measured. Include anecdotal and objective measurements of how the CFAR infrastructure award provides "added value" or the unique contributions of CFARs that cannot be provided by research awards. Select long-term goals for the funding period, and annual milestones for the first year. In addition to other items, place information about any advisory committees under the Administrative Core. Describe the membership of all committees, the basis for selection of participants, and terms of appointment, authority and responsibility. The ability to manage the CFAR award will be judged by the clarity and thoughtfulness of the scientific management strategies proposed for the Administrative and Developmental Core sections of the proposal. Reviewers will also consider how the CFAR uses the annual strategic planning process for the selection and organization of additional cores through such methods such as acquisition of information, outside support of cores, and participation of the AIDS investigators at the applicant institution(s) in core development and usage. b) 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 examples of justifiable but not necessarily compatible policies that might be used to address funding issues. Funding issues are an example of an area that a CFAR considers in the development of policies and procedures. o CFAR funding allocated by discipline in proportion to research performed in those disciplines o CFAR funding allocated for projects based on a majority vote of all members in an individual CFAR o CFAR funding allocated for projects based on majority vote of an internal advisory board Procedures should be considered to be a set of specific actions used to conduct the affairs of the CFAR. Procedures should specify how various tasks will be accomplished within the policy guidelines of the CFAR. Policies and procedures should describe: o the proposed roles of the CFAR director, core directors, CFAR investigators, advisory boards, and institutional officials in the decision- making process. o the annual strategic planning process. Examples of issues CFAR members should consider: 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 are developed, including the annual strategic plan and the noncompetitive renewal. o other mechanisms used to determine AIDS basic and clinical research core needs at the applicant institution(s), assign priorities to potential cores, and select the basic and Clinical Cores to be included in the application. 2. 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 through the Developmental Core: 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 are encouraged to explore the use of the Developmental Core to fund a collaborative study that encompasses two scientific disciplines, especially two that may not have previously collaborated (e.g., basic scientists and scientists studying complementary and alternative medicine, such as chiropractic or acupuncture; or behavioral scientists and population geneticists). Examples provided are not meant to be all-inclusive. Applicants may wish to consult with 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- review selection, and outcome evaluation of projects supported by the Developmental Core. The Developmental Core director is responsible for ensuring that all developmental studies involving human or animal subjects have the appropriate approvals (i.e., domestic and foreign IRB, FWA, IACUC, human subjects research training, etc.). Applicants must inform the NIH of any awards made for developmental studies involving foreign sites as soon as possible. Applicants who have current CFARs should describe outcome evaluation of previously funded developmental projects. The time period should include all years for which the CFAR was funded. The applicant should use the table provided for this purpose on the CFAR program announcement web site (http://www.niaid.nih.gov/research/cfar/cfarpa.htm) and include with the application (Table 3). The Developmental Core section should include a plan for the use of the first year developmental funds. 3. Basic Science Cores Basic Science Cores provide equipment, training, services, quality control, and expertise/advice for 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 should foster collaboration between basic and clinical investigators. Basic science cores do not substitute for resources that are obtainable commercially, or replace existing resources normally supported by individual research grants. Cores should have a clear focus, and contribute to translational research. Reviewers will look for an emphasis on well managed and efficient core functions above the overall number and breadth of cores in a given application. Please use Table 4 to indicate all core facilities at your institution and whether or not CFAR members will be utilizing them. 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 number of anticipated users and the percent time of use by each. Mechanisms should be described to prioritize core usage, evaluate use annually, and justify level of continued CFAR support in the context of evolving scientific priorities at the applicant institution(s). 4. Clinical Cores Clinical Cores should have a clear focus and provide the resources for AIDS translational research between collaborating clinical and basic scientists. The primary distinction between a Basic and Clinical Core is that a Clinical Core has direct interaction with patients. This may involve developing a database for clinical specimens, an intervention for a behavioral study, or development of INDs. Activities that will not be supported by a CFAR Clinical Core are normal patient care, including screening of clinical specimens, diagnosis, treatment or rehabilitation. Applicants are reminded of the Form 398 requirement to address the involvement of human subjects and vertebrate animals in the work proposed. Any new work involving human subjects proposed in the Clinical Core sections of this application that are not covered by existing IRB approvals will require such approvals prior to funding. CFAR Cores proposing direct work with human subjects or vertebrate animals should provide full Human Subjects Research and Vertebrate Animals Research sections as per Form 398 instructions. Mechanisms should be described to prioritize core usage, evaluate use annually, and justify level of continued CFAR support in the context of evolving scientific priorities at the applicant institution(s). F. Institutional Commitment Commitment of the CFAR institution is particularly important for the coordination of resources across the broad areas and potential boundaries of research supported by the co-funding Institutes. Examples of the types of institutional commitment that are demonstrated by current CFARs are: level of institutional funding, space allocation, co-funding, endowments, designation of center program status in the institutional bylaws, and provision of a waiver or partial waiver for indirect costs for certain components of the CFAR, such as funding of the Developmental Core. These are examples, and are not exclusive of other possible ways in which an institution may demonstrate support for the CFAR. The applicant must provide a letter(s) from the appropriate institutional official(s) (e.g., Dean, President, or Provost) defining: 1. Position, authority, and reporting responsibility (on institution's organizational chart) for the CFAR director 2. Financial and other resource support for the CFAR that will be provided by the applicant institution(s) 3. Authority or influence that the CFAR director has and or will have over other AIDS projects, facilities and space, as well as decision-making authority for new faculty and support personnel G. Scientific Programs and Competitive Supplements In order to take full advantage of the ability of CFARs to organize AIDS research at an institution, to encourage collaboration between scientific disciplines and diverse areas of expertise, and to explore significant questions and problems in AIDS that are not being addressed, a CFAR is encouraged, but not required, to identify one, or several, Scientific Programs. A Scientific Program is defined as an area of scientific activity for a group of investigators who share common research interests and goals and participate in competitively funded research. Scientific Programs function to encourage an existing research direction or a new scientific focus. Examples of possible Scientific Programs include, but are not limited to: HIV/AIDS Vaccine Development, HIV/AIDS Prevention, and HIV/AIDS Treatment. The examples provided are meant to be broad enough to include diverse biomedical disciplines, e.g., behavioral change, epidemiology, pathogenesis, clinical research, etc. The Scientific Director is expected to encourage new collaborations, the identification of high risk/high impact studies, and scientific gaps that cannot be addressed by standard funding mechanisms, as well as the submission of new proposals for peer reviewed funding. Such studies may be conducted both within a given scientific program, and between scientific programs within the CFAR. The success of programs will ultimately be measured by expansion of NIH-supported funding for the program, and the establishment of successful collaborations within the program and between programs. Programs should be of adequate size and scientific quality, should exhibit a high degree of interaction, are encouraged to be multi-disciplinary, and should be capably led. To insure adequate size and quality, a Program must have the equivalent of at least three entire peer-reviewed and funded research projects from a minimum of three separate, independent principal investigators in the proposed Program. Peer-reviewed, funded research sub- projects of larger program grants (e.g., P01s) may be counted as separate projects. Peer reviewed awards that may be used to comprise a Program will come from the Funded Research Base of the CFAR. Methods to develop collaborations will vary at each CFAR, but may include formal or informal planning meetings, seminars, and retreats, new, shared resources, or key recruitments. There are three possible ways to fund new collaborative projects: (1) through new R01 or P01 applications; (2) with CFAR base funding through the Developmental Core; (3) through competitive supplements. The first is self- explanatory, and the second and third are explained in more detail below. CFARs and the Scientific Director are strongly encouraged to identify innovative, high-risk/high impact projects as a strategy to increase collaboration among CFAR investigators. Proposed projects are encouraged to be multi-disciplinary. Projects may be submitted to the NIH as R01 or P01 applications, or may be funded through the Developmental Core of the CFAR. Examples of scientific projects are provided to suggest a variety of collaborations that could be considered, but are not limited to those that are listed: Pulmonary Complications of HIV Infection, Collaborations to Address Human Subject Issues in International AIDS Research, Collaborations to Increase Awareness of Drug-Abuse Complications in AIDS Therapeutic, Vaccine, and Behavioral Studies, Scientific Collaborations with Minority Investigators, Collaborations to Initiate or Expand AIDS Studies that Address Gender Differences, Collaborations to Initiate or Expand Efforts to Develop and Implement Behavioral Prevention Interventions in Clinical Treatment Settings, Interdisciplinary Collaborative Studies Investigating the Interplay between Cancer Pathogenesis, Virus Infections and HIV Induced Immune Suppression, Well-designed Studies to Characterize and investigate Traditional Medicine or Complementary and Alternative Medicine Practices Used in the Treatment of HIV/AIDS, and Sustainable Interventions in Developing Countries. To provide additional encouragement for new collaborative studies, the NIH may accept requests on an annual basis for competitive supplements for scientific projects. An NIH Institute participating in the co-funding of the Program may solicit requests for competitive supplements to launch scientific programs in a specific area of AIDS research in line with the mission of that Institute. In addition, the NIH CFAR Program, and the Office of AIDS Research, will provide competitive supplements for collaborative projects in areas identified by the NIH, and NIH Advisory groups, with suggestions from CFAR investigators. Both of these funding mechanisms are subject to funding availability each year; and funding opportunities, if available, will be announced each year in early January on the NIH CFAR web site, or by email communication to eligible investigators. Funding of the Scientific Director position(s) can be requested for development of a scientific program(s) through the Administrative Core. Funding for collaborative projects will be through the Developmental Core, either from base CFAR funds, or through a competitive supplement. At the time of submission of a competitive renewal application, applicants should identify a scientific director(s), the scientific program(s), and specific plans that will be used to develop collaborative activities. In addition, procedures for identifying projects, reviewing project applications, and choosing projects to be supported, should be clearly identified. Policies for continuing, terminating/revising, or rebudgeting funds for a project should be clearly identified in the event that the project director leaves the institution, the study achieves an earlier endpoint than expected, or other unexpected data or results becomes available that suggests a change in focus. These policies will be evaluated by the reviewers to determine the ability of the applicant to responsibly manage funds for these projects during the CFAR funding period, and will be incorporated into the terms and conditions of award if the CFAR application is successful. Only CFARs that have been funded for one year or longer are eligible to utilize base CFAR funds or receive competitive supplements for funding of these scientific programs and collaborative projects. As described under "Funds Available," CFARs that successfully recompeted for renewal in 2003, and that have a funded research base that is greater than $40M or greater than $80M, will be eligible to submit a revised proposal and budget request to increase the CFAR base funding. If a CFAR chooses to submit a revised proposal, it may also respond to the scientific collaboration component of the program at the same time. The CFAR would need to respond to competitive supplement initiatives separately from the revised proposal. The CFAR strategic planning process should be used to develop policies and procedures for identifying and prioritizing projects, and to develop funding plans for projects to be funded through the Developmental Core using base CFAR funding. Funding for these projects is expected to be greater than for standard developmental awards, and must be fully justified. At the Annual CFAR Directors' Meeting, investigators will be required to present a status report and to describe future plans for ongoing collaborative projects. Before developing this part of the application investigators are strongly encouraged to discuss plans with appropriate NIH representatives identified under "Inquiries." CFAR BUDGET ITEMS A. Percent Effort The percent effort requested should be limited to time devoted specifically to managing CFAR activities and not to research. 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. All requested personnel costs should be carefully justified. The percent effort of the CFAR director should be justified in the context of 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. The use of Developmental Core funds for junior faculty salary support is allowed. Established investigators with R01-type grants are expected to have salary support from other sources. B. 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. C. 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. D. Travel CFAR Directors' Meeting(s) The CFAR Director is required to attend the Annual Directors' Meeting. The CFAR director, the CFAR administrator, and one senior scientist per center may be provided support to meet at least once, and possibly 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 direct cost of $6,500 for the CFAR Directors' Meeting(s). 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, nor should they be used for advertising and promotion. They may be used for travel to meet with collaborators at foreign sites. For example, this travel could be used to promote collaboration among CFAR investigators and AIDS investigators not in a CFAR program, or at distant cores, for meetings of core directors of similar cores to share operational and scientific expertise, and for participation of junior or developing world investigators at CFAR-sponsored meetings and workshops. These additional travel funds should not exceed $20,000 annual direct costs. DEVELOPMENTAL CFARs (D-CFAR) The goal of a D-CFAR is to provide support for applicants to develop collaborations, experiment with core facilities that may be important to support AIDS investigators at the institution, and to correct any deficiencies that might adversely effect an application for a standard CFAR award. For example, applicants may wish to initiate AIDS studies with investigators in the developing world, or expand collaborations between behavioral science and basic science investigators at an institution that has traditionally had a more narrow scientific focus in AIDS and AIDS-related research. Other examples include expansion of communications technology among investigators who have begun, or are planning, collaborative studies, using the Developmental Core to fund a collaborative study that encompasses two scientific disciplines, especially two that may not have previously collaborated (behavioral scientists developing AIDS prevention interventions, and clinicians conducting clinical trials of AIDS therapeutics), or developing an outreach program that could not be started through institutional or research grant funding. The D-CFAR mechanism may not be used to obtain a supplement to an existing CFAR award. All eligibility requirements and specific descriptions provided in this PA for the CFAR awards are also required for and relevant to, the D-CFAR awards. The minimum number and type of cores for a D-CFAR is the same as for a standard CFAR: one administrative, one developmental, one basic and one clinical. There are several differences between a D-CFAR and a S-CFAR. The maximum funding level for the D-CFAR award is $750,000 and it is a one-time award for 3 years. We encourage independent AIDS investigators interested in expanding collaborative efforts at their institution to consider applying for this award. Applicants who have never received a CFAR award are eligible to apply, as are previous CFAR applicants who have not been successful in recompeting for the CFAR award. Applicants who have not received a CFAR award may choose to apply for either a standard or developmental CFAR award. Because the D-CFAR is designed to assist the applicant in the organization and development of a competitive CFAR application, reviewers will look very carefully at previous CFAR applications from the same applicant regarding the feasibility of overcoming obstacles identified by previous reviewers. Applicants should clearly indicate in the title of the application and in the abstract that this is for the D-CFAR award. If no indication is provided it will be assumed that the application is for a standard CFAR. Applicants applying for a D-CFAR award should plan on providing as much detail for the Administrative and Developmental Cores as is required for the standard CFAR application. Please see the instructions for the administrative and Developmental Core for CFARs, above. The strategic plan should provide sufficient detail about procedures that will be used to identify challenges at the institution and proposed solutions that would lead to development of a competitive CFAR application within the three-year funding period. Proposed outcome measurements for strategies, and core facilities selected for year 1 should be clearly explained, as well as procedures for adjusting the plan for years 2 and 3, should changes be needed. Like the standard CFAR award, the D-CFAR provides funding to foster synergy and improve coordination of research, support emerging research opportunities, and promote economy of scale through resources shared by multiple independent laboratories. D-CFARs also encourage other activities that serve the requirements of AIDS research. See 'Additional CFAR supported activities'. Any of these activities may be fostered through a D-CFAR award. Because both the funding period and level are less than that for a CFAR award, the D-CFAR is not expected to propose all core facilities that would be proposed for a standard CFAR. The emphasis for D-CFAR is on the identification of gaps or deficiencies that would hinder development of a competitive CFAR application, and core facilities that will reduce or eliminate these gaps. MECHANISM OF SUPPORT This PA will use the NIH center core grant (P30) award mechanism. The applicant will be solely responsible for planning, directing, and executing the proposed project. The total project period for CFAR grants may not exceed five years, and applicants are encouraged to apply for five years. For D-CFARs the total requested project period may not exceed three years. APPLICATIONS IN RESPONSE TO THIS PA MUST BE PREPARED USING A MULTI-PROJECT GRANT APPLICATION FORMAT; SPECIFIC INSTRUCTIONS FOR PREPARING THE CFAR APPLICATION CAN BE FOUND AT THE CFAR WEBSITE: http://www.niaid.nih.gov/research/cfar/cfarpa.htm ELIGIBLE INSTITUTIONS Domestic institutions may submit an application if the institution has any of the following characteristics: o For-profit or non-profit organization o Public or private institutions, such a university, college, hospital, and laboratory o Units of State or local government Foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. The principal investigator should be a recognized leader in the field of AIDS research. SPECIAL REQUIREMENTS 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 WHERE TO SEND INQUIRIES We encourage inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Please check the following website for any changes in contact information: http://www.niaid.nih.gov/research/cfar/cfarpa.htm. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct questions about scientific/research issues to: For questions regarding D-CFAR, or CFAR management issues, scientific issues, or program interests of NIAID please contact: Janet M. Young, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Room 4137, MSC-7626 6700-B Rockledge Drive Bethesda, MD 20892-7626 Telephone: (301) 496-6714 FAX: (301) 402-3211 Email: jy6r@nih.gov For questions regarding D-CFAR and CFAR scientific and program interests of other Institutes and Centers please contact: FIC Jeanne McDermott, Ph.D. Division of International Training and Research Fogarty International Center Room B2C39 MSC 2220 31 Center Drive Bethesda, MD 20892-2220 Telephone: (301)-496-1492 FAX: (301) 402-0779 Email: jm548f@nih.gov NCI Jodi B. Black, Ph.D. AIDS Malignancy Program National Cancer Institute Room 3A44, MSC-2440 31 Center Drive Bethesda, MD 20892-2440 Telephone: (301) 402-6293 FAX : (301) 496-0826 Email: jb377x@nih.gov NCCAM Morgan N. Jackson, M.D., M.P.H. Division of Extramural Research and Training National Center for Complementary and Alternative Medicine 6707 Democracy Blvd., Suite 401 Bethesda, MD 20892-5475 Bethesda, MD 20817 (use for express/courier service) Telephone: (301) 402-1278 FAX: (301) 480-3621 email: mj145m@nih.gov NHLBI Elaine Sloand, M.D. Office of the Director National Heart, Lung and Blood Institute Room 4A11, MSC 2490 31 Center Drive Bethesda, MD 20892-2490 Telephone: (301) 496-3245 FAX: (301) 594-1290 E-mail: es38n@nih.gov NICHD Pat Reichelderfer, Ph.D. Contraception and Reproductive Evaluation Branch National Institute of Child Health and Development Room 8B13 6100 Executive Boulevard Rockville, MD 20852 Telephone: (301) 496-1661 FAX: (301) 480-1972 E-mail: pr20f@nih.gov NIDA Jag Khalsa, Ph.D. Center on AIDS & Other Medical Consequences National Institute on Drug Abuse Room 5198, MSC 9593 6001 Executive Blvd. Bethesda, MD 20892-9593 Telephone: (301) 443-1801 FAX: (301) 594-6556 or 443-4100 Email: jk98p@nih.gov NIMH Dianne Rausch, Ph.D. Center for Mental Health Research on AIDS National Institute of Mental Health Room 6209, MSC 9619 6001 Executive Blvd. Bethesda, MD 20892-9619 Telephone: (301) 443-7281 FAX: (301) 443-9719 E-mail: dr89b@nih.gov o Direct questions about peer review issues 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) 496-2550 FAX: (301) 402-2638 Email: dt15g@nih.gov o Direct questions about financial or grants management matters to: Lori Zimand Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2246, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 451-4580 FAX: (301) 493-0597 Email: lz36k@nih.gov SUBMITTING AN APPLICATION Applicants for P30 grants must follow special application guidelines in the NIAID Brochure entitled SPECIAL INSTRUCTIONS FOR PREPARATION OF THE CFAR APPLICATION; this brochure is available via the WWW at: http://www.niaid.nih.gov/research/cfar/cfarpa.htm Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted on the dates indicated on the front page of this document. 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. 5/01) Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS") will be judged non-responsive and will be returned to the applicant. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as applicant is developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept the application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. The 350-page limit also applies to these applications. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. For applications in response to this program announcement, the page limitation is 350 pages for the research plan of the CFAR or D-CFAR application, excluding appendices, required tables (http://www.niaid.nih.gov/research/cfar/cfarpa.htm), Bio-sketches, and Other Support, literature cited sections, and other sections that normally fall outside of sections A-D of the research plan. Please note that appendices are provided only to the reviewers assigned to the application, and not to all reviewers. Appendices should not contain information required for review by other committee members, and are limited to 10 documents or 100 pages. The 350-page limit is a maximum, and applicants are encouraged to be concise. Applicants submitting a revised application may include an additional 30 pages to discuss the response to the reviewers' comments. It is helpful to the review committee if these are placed at the beginning of the research plan, with reference to locations in the application where changes can be found. Other support should not be provided in the initial application submission. SPREADSHEETS AND TABLES NIH will provide applicants with a spreadsheet (Excel) indicating all investigators receiving NIH AIDS funding at an applicant's institution (or institutions if a multi-institution application), arranged by NIH Institute. Applicants should indicate in the "Participating" field provided, those investigators who have formally agreed to participate in the CFAR, and a brief explanation at the bottom of the table as to why investigators may not be participating. Indicate the type of participation, i.e., core director, user of Virology Core, etc. The NIH will provide tables in MSWord for additional information required of both new and recompeting applications. These may be found at the CFAR program announcement website: http://www.niaid.nih.gov/research/cfar/cfarpa.htm SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and three signed 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/courier service) Two single-sided copies of the application (text) and five copies of appendices must be sent 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 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: the receipt dates described on the first page of this document must be followed. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS 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 submitted for this PA will be assigned on the basis of established PHS referral guidelines. P30 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. As part of the initial merit review, all applications will: o Receive a written critique o Be assigned a priority score o Receive a second level review by the National Allergy and Infectious Diseases Advisory Council and the appropriate Councils or Boards of the co- funding Institutes REVIEW CRITERIA In addition, the following review criteria specific to this PA will be used in evaluation of applications. Review criteria are based on the mission of the CFAR Program and mechanisms for achieving this mission. The initial review group (IRG) will evaluate D-CFAR, and 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 in 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 & Methods -Choice of Cores and their -Preliminary Results Operating Structures for new applications -Progress Report for -Progress Report for renewal applications 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 an outstanding 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. Review criteria are listed separately for the developmental CFAR (D-CFAR), the standard CFAR (CFAR), awards. REVIEW CRITERIA FOR D-CFARS Significance The effect that a D-CFAR award would have on an applicant's AIDS research efforts 1. Evidence that the proposal will lead to development of a competitive standard CFAR application 2. The ability of Cores to support the research base, foster synergy, enhance AIDS research collaborations and produce an economy of scale 3. The ability of proposed scientific communication, outreach, training efforts, international collaborations, and collaborations with industry to assist AIDS investigators and lead to development of a competitive CFAR application 4. Developmental Core procedures for selection of projects and outcomes evaluation Approach The quality of the CFAR scientific planning and management process 5. Annual strategic planning process 6. Policy and procedures to judge value of Cores and reassign funding priorities; outcome measurements 7. Methods for selection of Basic and Clinical Core users and for prioritization of use 8. Policies and procedures to identify gaps and mechanisms for filling them Innovation The utilization of D-CFAR resources in unique ways to achieve the scientific goals of all AIDS investigators at the participating institution(s) 9. The degree of variety in AIDS research projects and disciplines that commit to participation in and coordination through the D-CFAR structure 10. The incorporation into the D-CFAR of resources (Cores, projects, cohorts, trials, etc.) that are supported in part or not at all by D-CFAR funds 11. Resources available to enhance a particular D-CFAR goal in order to facilitate future collaborative interactions Investigator The choice of appropriate leaders to carry out the D-CFAR mission 12. Choice of D-CFAR director, e.g., managerial experience, commitment, leadership in AIDS research and at the applicant institution 13. Choice of core directors and key personnel, e.g., qualifications, competence and commitment 14. Proposed advisory groups: responsibility, methods for their selection, and contribution to the overall D-CFAR goals Environment The likelihood that a D-CFAR will achieve its objectives 15. Evidence for D-CFAR providing value added to the AIDS research at the institution 16. Institutional commitment including space, institutional financial support and other institutional resources and oversight provided for D-CFAR activities 17. Appropriateness of budget of the overall D-CFAR and of the individual cores 18. Proposed strategy for expanding the D-CFAR focus REVIEW CRITERIA FOR CFARS Significance The effect that a CFAR award would have on CFAR investigators' AIDS research efforts 1. The ability of Cores to support the research base, foster synergy, enhance AIDS research collaborations and produce an economy of scale 2. Evidence that CFAR will enhance proposed scientific communication, outreach, training efforts international collaborations, and collaborations with industry 3. Developmental Core procedures for selection of projects and outcomes evaluation Approach The quality of the CFAR scientific planning and management process 4. Annual strategic planning process 5. Policy and procedures to judge value of cores and reassign funding priorities; outcome measurements 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 membership selection Environment The likelihood that a CFAR will achieve its objectives 12. Evidence for CFAR providing value added to AIDS research at the institution 13. Institutional commitment including space, institutional financial support and other institutional resources and oversight provided for CFAR activities 14. Previous history of CFAR support for developmental projects and outcomes 15. Previous history of translational research efforts 16. Appropriateness of budget for the CFAR overall and of the individual Cores REVIEW CRITERIA FOR SCIENTIFIC COLLABORATIONS Significance The effect that a collaborative project would have on the overall AIDS effort at the institution 1. Evidence for innovative, high-risk/high-impact project(s) that will address significant problems or gaps in the AIDS field that cannot be addressed easily through other funding mechanisms 2. Evidence that the proposed project(s) will enhance new multidisciplinary collaborations, that may include international collaboration, collaboration with industry, or collaboration with junior or minority investigators 3. Evidence that the process for selection of projects to be funded will lead to independent funding of high-risk/high-impact studies Approach - The quality of the CFAR scientific projects, including planning and management process 4. Project design and appropriate Core selection 5. Policy and procedures to identify and select scientific projects, reassign funding priorities, and to measure outcome of projects Innovation The identification of a unique project or approach to solve an significant question or gap in AIDS research 6. The degree of variety in AIDS scientific disciplines that are included in proposed scientific projects 7. The degree of innovation in project selection and experimental design Investigator Choice of appropriate scientists to lead the identification and development of collaborative projects 8. Choice of Scientific Director for scientific areas proposed: leadership in the field of AIDS 9. Choice of project leader for individual collaborative projects proposed: scientific qualifications, commitment Environment 10. Availability of appropriate scientific expertise 11. Previous history of support for developmental projects and outcomes 12. Appropriateness of budget for the scientific projects and of the individual Cores 13. Evidence that scientific collaborative areas and projects arise from the scientific environment at the CFAR institution(s) ADDITIONAL REVIEW CRITERIA: In addition, the following review criteria items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below). INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL CONSIDERATIONS DATA SHARING: The adequacy of the proposed plan to share data. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities 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: A. CFAR Strategic Plan B. CFAR Policies and Procedures C. CFAR Advisory Committee(s) authority and responsibility D. CFAR Advisory Committee for the identification and selection of research projects and awards (D-CFAR) Any changes in these items from the Notice of Award will require concurrence of NIH. REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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 clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/ notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/ guidelines_amended_10_2001.htm The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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 is available at http://grants.nih.gov/grants/funding/children/children.htm. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: tc "REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS" NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as "covered entities") must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. 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 PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations; No. 93.213, Research and Training in Complementary and Alternative Medicine; No. 93.242, Mental Health Research Grants; No. 93.279, Drug Abuse Research Programs; No. 93.393, Cancer Cause and Prevention Research; No. 93.394, Cancer Detection and Diagnosis Research; No. 93.396, Cancer Biology Research; No. 93.839, Blood Diseases and Resources Research; No. 93.855, Immunology, Allergy, and Transplantation Research; No. 93.856, Microbiology and Infectious Diseases Research; No. 93.864, Population Research; No. 93.865, Center for Research for Mothers and Children; and No. 93.989, Senior International Fellowships. 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 NIH Grants Policy Statement is available at http://grants.nih.gov/grants/policy/policy.htm. This document includes general information about the grant application and review process; information on the terms and conditions that apply to NIH Grants and cooperative agreements; and a listing of pertinent offices and officials at the NIH. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the 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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices



NIH Office of Extramural Research Logo
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH... Turning Discovery Into Health®



Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.