THE INTERNATIONAL CENTERS FOR EXCELLENCE IN RESEARCH (ICER) CLINICAL RESEARCH AND MANAGEMENT TRAINING PROGRAM AWARD RELEASE DATE: May 3, 2002 RFA: TW-03-002 PARTICIPATING INSTITUTES AND CENTERS (ICs): Fogarty International Center (http://www.nih.gov/fic) National Institute of Allergy and Infectious Diseases (http://www.niaid.nih.gov/) LETTER OF INTENT RECEIPT DATE: June 13, 2002 APPLICATION RECEIPT DATE: July 11, 2002 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The Fogarty International Center (FIC), in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), invites applications from nonprofit, private or public, domestic educational and research institutions to develop or expand current graduate health professional school curricula to provide training relevant for the conduct and/or management of international clinical research on infectious diseases at NIAID- and FIC- supported research sites in developing countries. Proposed curricula should be designed to provide courses leading to expert certification in specific skills required to carry out clinical research or administer research or both in the context of international collaboration. Clinical research training and/or management programs will initially provide training for members of the NIAID International Centers of Excellence in Research (ICER) Program (http://www.niaid.nih.gov/dmid/icer/) with sites currently located in Bamako, Mali, Chennai, India, and Kampala, Uganda. The goal of the ICER program is to develop a sustained research program of excellence in areas of high infectious disease burden through partnerships with scientists and research managers at the foreign sites. Trainees from other international research sites in resource poor countries with significant NIAID and FIC investments will participate as the program evolves. Applications in response to this RFA will address the NIAID and FIC goals of facilitating independent research capacity through expanded opportunities for training in the administration, management and conduct of international clinical research. RESEARCH OBJECTIVES Background and aims: Multiple activities are supported at international research sites by NIAID and FIC with the intention to establish long term collaborative and integrated infectious disease research partnerships between U.S. and foreign institutions, as well as to develop independent research capacity at foreign sites in less developed countries. The new ICER program aims to establish sustained collaborative research programs involving NIAID intramural scientists and local scientists at overseas research centers, and to expand research and research training opportunities at these sites through extramural programs. The NIAID ICER program will support research on all infectious diseases of local public health importance. This ICER clinical research and management training program is intended to establish a training resource, tailored to the needs of scientists at the ICER sites that is capable of expanding core skills in clinical research and research management in accordance with internationally accepted guidelines. Few institutions in countries with high burdens of infectious diseases provide formal training in the conduct of clinical research and management of research programs and few U.S. programs for advanced training in clinical science offer the appropriate spectrum and levels of training to accommodate the targeted needs of foreign scientists and health professionals. The long-term goal is the development of a self-sustaining educational program relevant to other international research and training efforts, including other NIAID- and FIC-supported international collaborative research programs involving extramural scientists. Therefore, specific objectives of this program are: 1) To assess clinical research and management training needs at ICER sites and to implement training curricula for investigators, research managers, administrators and others from these sites 2) To develop a curriculum of clinical research training activities that will strengthen the capacity of investigators at ICER and other NIAID- and FIC-supported international sites to conduct clinical infectious disease research. It is expected that this curriculum will be developed as a comprehensive package that will include training in, but not limited to, the following elements: o Good clinical practice o Clinical research methodology (trial design, data management etc.) o Clinical microbiology o Epidemiology and biostatistics o Responsible conduct of research 3) To develop a curriculum of research management training that will strengthen the capacity of investigators and institutions at ICER and other NIAID- and FIC-supported international sites to effectively manage infectious disease research programs and projects. It is expected that this curriculum will be developed as a comprehensive package that will include, but will not be limited to, the following elements: o Project management o Financial management and good accounting practices o Institutional Review Board processes o Regulatory procedures o Human resources development. Applicants may propose to provide curriculum for clinical research training or research management training or both. Training should focus on developing skills and mentoring for ICER scientists selected to play specific roles in NIAID-supported clinical research projects. Individual courses should be planned within each type of curriculum to result primarily in expert certification in skills required for design, conduct, and management (including administrative management) of clinical research and clinical trials, in accordance with internationally accepted guidelines. The initial needs assessment will focus on ICER sites. However, as the program matures, training may be provided for other NIAID- and FIC-funded international research sites. No research will be conducted as part of this training grant. Prior to the initial needs assessment, specific training needs at each of the ICER sites may not be known. Therefore, applicants should propose plans, to be undertaken during the first year of the award, for assessing training needs at each of the ICER sites. In addition, the application should identify and describe the core elements of clinical research training and research management training curricula needed to enhance the infectious disease research capacity of institutions in developing countries. The application should also describe plans and opportunities for mentoring individuals from these sites and institutions. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) international research training grant (D43) award mechanism. At the time of award, these grants may be converted to cooperative agreements in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator. The responsibilities of the possible cooperative agreement mechanism are described under "Proposed Terms and Conditions of Award" in the section entitled "Special Requirements." As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The total project period for an application submitted in response to this RFA can not exceed five years. Facilities and administrative (F & A) costs are limited to eight percent in these awards. At this time, the FIC and NIAID have not determined whether this solicitation will be continued beyond the present RFA. The anticipated award date is October 2002. FUNDS AVAILABLE Approximately $1 million in FY 2002 has been committed to fund an estimated one or two new training program awards in response to this RFA. Applicants can submit a clinical research training program, or a research management training program, or a combined clinical research and research management training program. Applicants can request up to $500,000 total costs for a clinical research training program or a research management training program application. If the applicant submits a combined clinical research and research management training program, the applicant can request $1,000,000. It is expected that a single award for a combined clinical research and research management training program will be made, or two awards, one for a clinical research training program and one for a research management training program, will be made. Because the nature and scope of the curriculum development and training proposed may vary, it is anticipated that the size of each award may also vary. Awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o Non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Domestic The applicant institution must have a faculty/staff that is active in clinical research and/or management/administration of clinical research programs, as evidenced by current research support and research publications. Experience in the conduct of clinical infectious disease research in developing countries is desirable but not required. An institution may submit only one application. 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. SPECIAL REQUIREMENTS 1) The Program Director (Principal Investigator) will expend at least 30 percent effort during year one of the award and at least 20 percent effort during the following years and have primary responsibility for all activities of the program. 2) Curriculum Directors will be appointed for International Clinical Research training tracks and/or Research Management training tracks. 3) The FIC Program Officer will be responsible for normal program and administrative stewardship of this award. As required for the coordination of activities or to expedite progress the FIC Program Officer may designate additional FIC or NIAID staff to provide advice or assistance directly to the grantee on specific scientific, educational or management issues. However, the FIC Program Officer will retain overall programmatic responsibility for the award and will clearly specify to the awardees the names and roles of any additional scientific coordinators and the lines of reporting authority. The FIC Program Officer will be a member of the Steering Committee established to coordinate curriculum and training plans, and manage joint activities. 4) The NIAID ICER Training Coordinator will be responsible for working with the leadership of the ICER sites and NIAID Global Health Sites to assist in ascertaining training needs and will be a member of the Steering committee. 5) The Steering Committee will consist of, at a minimum, the PI(s) and Curriculum Directors, the FIC Program Officer, and the NIAID ICER Training Coordinator. The Steering Committee will work closely with the leadership team of the ICER Sites, which includes NIAID Intramural and Extramural Principal Investigators, the Program Director from the foreign site as well as other US and foreign ICER investigators as deemed necessary to conduct the activities of the training program. The following Terms and Conditions will apply if the application is converted to a Cooperative Agreement: These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument to be used for this program is a cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient"s activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the activities will be shared among the awardees, the FIC Program Officer and NIAID ICER Training Program Coordinator. Awardee Rights and Responsibilities 1. Training Needs Assessment: An initial needs assessment for each ICER site will be performed by the awardee to: o Examine existing infectious disease clinical research and/or research management capabilities o Discuss overall five-year research goals of each site with the on-site ICER director o Identify critical gaps in clinical research and/or research management expertise that could be addressed by training o Create a training development plan to guide training activities for the duration of the award. 2. Required Meetings: The Steering Committee shall meet at least once each year. In addition, Program directors and other key personnel should also attend the NIAID International Centers for Tropical Disease Research Annual Meeting also in Bethesda, Maryland. 3. Awardees have primary authorities and responsibilities to define objectives and approaches of the curriculum developed, to plan and conduct training in this curriculum. In addition, the awardees will have specific responsibilities for: o Meeting with the Steering Committee to coordinate and finalize plans, procedures and survey tools for the needs assessments of the ICER sites. o Providing leadership in the construction and annual updating of the curriculum based on evaluation and need. All courses should be consistent with international standards for the conduct, oversight and management of international clinical research as outlined by the International Council on Harmonization o Establishing monitoring and evaluation procedures to assess the effectiveness of the curriculum and training provided to trainees within their program. o Participating in the Steering Committee including the presentation and discussion of the awardee"s curriculum, training and evaluation plans, progress and results and revision of training development plans. o Maintaining a mutually acceptable arrangement with the ICER faculties and institutions to transfer clinical research and research administration training capacity during the award period. o Implementing any program-wide shared curriculum, training, evaluation or reporting procedures, where feasible. o Developing and disseminating any computerized or web-based learning courses developed under this award to ICER sites, and other FIC- and NIAID- supported programs upon request of FIC or NIAID Program Officers. C. NIH Staff Responsibilities The FIC Program Officer, in consultation with the NIAID ICER Program Coordinator, will have substantial scientific and programmatic involvement during the conduct of this activity, through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. The FIC program officer will be familiar with the scientific agenda of FIC and NIAID joint programs and will facilitate coordination of training across these programs. The NIAID ICER Training Coordinator will work closely with the FIC Program Officer, and ICER investigators to assist in identifying clinical research training needs. The NIAID ICER Training Coordinator will be familiar with the scientific agenda of the ICER sites and other NIAID Global Sites and will facilitate coordination of training across NIAID sites. The FIC Program Officer and the NIAID ICER Training Coordinator will: o Serve as members of the Steering Committee o Provide advice on the management of the training provided, technical content of the curriculum to fulfill U.S. DHHS requirements for clinical research, and evaluation of the impact of the training o Facilitate communication and exchange of information among trainees and NIAID intramural and extramural staff associated with ICER activities o Organize interactions with relevant NIAID and FIC staff to: provide scientific and administrative technical assistance, obtain access to NIAID contracts providing resources for international clinical study support, site monitoring, and research reagents (e.g. AIDS, tuberculosis, malaria reagent repositories) and, increase access of trainees to additional mentoring opportunities through other NIAID- and FIC-supported international clinical research projects and research training programs. Each ICER site has an NIAID Intramural and Extramural Principal Investigator as well as a foreign ICER Program Director and foreign principal investigators. The NIAID ICER Training Coordinator will work with all members of the ICER leadership team to assist in identifying clinical research training needs. D. Collaborative Responsibilities The success of the ICER clinical research training programs will depend in part on the collaborative interactions of the awardee program director and faculty, the FIC Program Officer, the program directors and faculty at ICER sites, and the NIAID ICER Training Program Coordinator. Therefore, the Steering Committee will meet at least once a year to provide the primary governance process for the collaborative efforts of the program and will have responsibility to: o Review clinical research needs as presented by ICER leadership and make recommendations for curriculum changes to accommodate training needs. o Identify needs for additional consultation on specific areas of infectious disease, clinical research, research administration or other training expertise, activities, or issues. o Review and approve the infectious disease clinical research training development plans for each ICER site based on the findings of the needs assessments. o Update and amend the clinical research training development plans for each ICER site based on progress, unanticipated events, etc. o Select appropriate candidates for training. E. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the FIC may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Steering Committee (with the FIC and NIAID members not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by FIC, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee"s right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues. o Direct your questions about scientific/research issues to: Barbara Sina, Ph.D. Division of International Training and Research Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 402-9467 FAX: (301) 402-0779 Email: sinab@mail.nih.gov o Direct your questions regarding peer review issues to: Madelon Halula Ph.D. Branch Chief, Scientific Review Program, DEA National Institute of Allergy and Infectious Diseases 67000B Rockledge Drive, Room 2150, MSC-7616 Bethesda, MD 20892-7616 Bethesda, MD 20817 (for express/courier service) Telephone: 301-402-2636 FAX: 301-402-2638 Email: mh30x@nih.gov o Direct your questions about financial or grants management matters to: Mr. Bruce Butrum Grants Management Officer Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1670 FAX: (301) 594-1211 Email: butrumb@mail.nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names, titles and institutions of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of the application submitted, the information that it contains permits the NIH to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Barbara Sina, Ph.D. Division of International Training and Research Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 402-9467 FAX: (301) 402-0779 Email: sinab@mail.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). Applicants should also follow the instructions for the Institutional NRSA found at the end of the PHS 398 instructions to construct their application. The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact Grants Info, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTAL INSTRUCTIONS: All expenses related to trainee participation in the program should be itemized on the PHS Form 398 (https://grants.nih.gov/grants/forms.htm) (NRSA substitute budget pages) in the categories listed in the RFA. All expenses related to faculty participation in the program should be itemized on the PHS Form 398 budget pages in the categories listed in the RFA. Total training expenses should be identified on PHS Form 398 (NRSA substitute page) under the "Other" category. Allowable costs requested for training at international institutions should follow the guidelines specified for U.S. institutions. Allowable costs Salary Program Director: The program director may receive salary and fringe benefits compensation for at least 30% professional effort devoted annually to the ICER training needs assessments, clinical research curriculum and training program creation during the award. Salary must not exceed the annual salary cap level from federal sources (https://grants.nih.gov/grants/guide/notice- files/NOT-OD-01-013.html). Faculty: Faculty at the applicant institution who provide critical design, development, implementation and refinement of essential components of the clinical research and/or research management curriculum or extended training and mentorship of the trainees may receive salary and fringe benefits. The responsibilities and time commitment for faculty receiving salary should be thoroughly described. Faculty Travel Funds should be requested for the program director and curriculum directors to travel to each ICER site for the proposed training needs assessments during the first year of the award. Funds may be requested for round trip economy airfare year on U.S. carriers (to the maximum extent possible) per diem and lodging for U.S. faculty participants to travel to the ICER institutions to teach short courses in years two to five of the award. Support Staff Up to $50,000 direct costs may be requested in the budget to provide salary and fringe benefits of support staff for the program at the grantee institution. The responsibilities and time commitment for personnel receiving salary support should be thoroughly described. Training related expenses Funds to support curriculum development related costs at the applicant institution (such as books, printed materials, audiovisual materials, computer software, etc.) as well as administrative expenses (such as photocopying, long distance phone and shipping costs, etc.) may be requested. Trainee Tuition, Fees and Insurance Funds for tuition, academic fees and self-only or family medical insurance for developing country trainees at the applicant and consortia institutions may be requested. Trainees from ICER sites may be paid a stipend comparable to their professional experience similar to other equivalent trainees at the grantee institution in accordance with the grantee institutional policies while involved in training. Applicants may wish to refer to the NRSA stipend levels as a guide. These are described on the web site (http://www.nih.gov/fic/programs.html). Trainee Travel Funds may be requested for one round trip economy class airfare per year on U.S. carriers (to the maximum extent possible) and local ground transportation for each trainee"s travel to the applicant institution. Funds should be requested for airfare, per diem and lodging for the Program Director and Curriculum Directors to attend required meetings at comparable U.S. government rates (http://www.gsa.gov/Portal/browse/channel.jsp?channelId=- 9838&channelPage=/channel/default.jsp&cid=1) for in the Washington, D.C. area. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies 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) At the time of submission, two additional copies of the application must be sent to: Madelon Halula Ph.D. Branch Chief, Scientific Review Program, DEA National Institute of Allergy and Infectious Diseases 67000B Rockledge Drive, Room 2150, MSC-7616 Bethesda, MD 20892-7616 Bethesda, MD 20817 (for express/courier service) Telephone: 301-402-2636 FAX: 301-402-2638 Email: mh30x@nih.gov APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the FIC and NIAID. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID+ in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score o Receive a second level review by the FIC Advisory Board. REVIEW CRITERIA The goals of NIH-supported research and training are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your application in order to judge the likelihood that the proposed curricula and training will have a substantial impact on the ethical pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, you may propose to carry out important training that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE a) The expected contributions of the proposed infectious disease clinical research and/or research management curriculum and training to ICER institutions" capabilities to conduct and/or manage clinical research and intervention trials. b) The expected contribution of the proposed clinical research and/or research management training plan to the ability of ICER sites to carry out NIH supported projects. (2) APPROACH a) The clarity and feasibility of the training needs assessment, curriculum development and training objectives. b) Adequacy of the program plan to achieve the proposed training needs assessment, curriculum development and training objectives including: o Thorough and appropriate clinical research and/or research management training needs assessments at ICERs during initial year of award, o Effective construction of clinical research and/or research management training development plans based on the needs assessments at each ICER to guide curriculum, training and evaluation activities for the duration of the award, o Strong and appropriate courses and overall curriculum at the grantee institution and short courses at the ICER sites that provide focussed training opportunities to fill presumed gaps in trainee expertise, o Individualized trainee assessment and training planning process that will effectively provide individuals with a variety of professional backgrounds from ICER sites with defined, certifiable expertise in clinical research and/or research management skills, o A strong individual mentoring process during training, o Appropriate assessment and enhancement of background skills needed by each trainee in areas such as bioethics, research methodology, technical writing, statistical methods, clinical practice, medical informatics and English as a second language (if necessary), o Process for periodic evaluation and revision of curriculum developed, o Process for periodic evaluation of trainee progress and mentoring activities, o Methods to monitor the short- and long-term impact of the training experience on the subsequent careers of the trainees and capacity for clinical research or research management in the home ICER, and o Plans for increasing transfer of sustainable core clinical research and/or research management training courses to ICER institutions and faculty during the course of the award including the development of ICER site appropriate distance learning courses and tools. (3) INNOVATION a) Innovation in clinical research and/or research management curriculum designed for ICER and other developing country trainees. b) Innovation in training ICER participants for independent involvement and leadership in the ethical design and conduct of clinical research and/or research management at their home institutions. c) Creativity of plans to include modern information technology to facilitate trainee access to electronic information resources, distance learning and collaborative interaction. (4) INVESTIGATOR Qualifications of the program director to lead, and other faculty to participate in, the proposed training needs assessments, curriculum development and training program. (The clinical research and/or research management experience and training accomplishments, especially in developing countries, should be included for the program director and each faculty participant. Any specific training in good clinical practice and/or experience with OHRP and FDA requirements for human subjects research and clinical trials should be documented.) (5) ENVIRONMENT The adequacy of the teaching facilities and other training resources including possible clinical research practical opportunities and the overall training environment at the applicant institution. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o INCLUSION a) The reasonableness of the proposed budget and duration in relation to the proposed training. b) The adequacy of the proposed plan to work in collaboration with scientists at ICER sites and ICER associated NIAID scientists, health professionals and staff in proposed curriculum, training and evaluation activities. c) Demonstrated willingness and ability to adhere to the terms and conditions of the Cooperative Agreement Award. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: June 13, 2002 Application Receipt Date: July 11, 2002 Peer Review Date: September, 2002 Council Review: September, 2002 Earliest Anticipated Start Date: October, 2002 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o The extent to which proposed training programs support and complement ICER sites and other FIC or NIAID efforts in clinical research REQUIRED FEDERAL CITATIONS 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 RFA 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 Catalog of Federal Domestic Assistance No. 93.989, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 and Title IV, Part A, (42 USC 241, 284 and 287) of the Public Health Services Act, as amended, and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92s. 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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