ACADEMIC PUBLIC PRIVATE PARTNERSHIP PROGRAM (AP4) PLANNING GRANT RELEASE DATE: July 30, 2003 RFA Number: RFA-CA-04-005 National Cancer Institute (NCI) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.394 and 93.395 LETTER OF INTENT RECEIPT DATE: October 21, 2003 APPLICATION RECEIPT DATE: November 20, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Academic Directors 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 The Developmental Therapeutics Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) invites academic cancer researchers to participate in the Academic Public Private Partnership Program (AP4). The purpose of the AP4 initiative is to provide support for the formation of new partnerships or significant expansions of existing partnerships among academia, industry, non-profit institutions, and government entities. The partnerships will conduct novel cancer therapeutic, prevention, diagnostic, and imaging intervention-directed research. The goal of the research will be to speed the translation of newly discovered cancer interventions to clinical trials. The NCI is assisting the formation of these partnerships by offering to academic and non-profit researchers a one-year planning grant, which is the subject of this RFA. The planning grant will be utilized by the academic or non-profit cancer researcher to study the feasibility of developing the pharmaceutical/non-profit/academic interaction necessary to establish and support a partnership, to hold a meeting of potential partners and select research projects for the potential AP4 Center. The research focus of these partnerships should take advantage of the latest discovery and development technologies and include projects which focus on cancers that meet the definition of orphan disease (those that affect less than 200,000 people per year in the United States) using a multidisciplinary approach. Biologically defined subsets of more common tumor types could also be defined as having "orphan" status. The research will occur at the AP4 Center with the advice and intellectual and financial support of industrial, academic, non-profit institute, other government partners and the NCI. The goal of the research conducted in the AP4 center is to generate novel interventions, development of which for human clinical trials will be supported by other financial resources. The impetus behind the creation of such a program is to promote public- private partnerships that will advance our basic knowledge of the molecular biological events that lead to cancer, and to apply that knowledge to the development of novel cancer interventions. The strategy addresses an important issue: how to bring together the necessary multidisciplinary expertise to discover new, more effective treatment, diagnostic, and prevention interventions for cancer, and shorten the time required to bring these new interventions to clinical trials. A number of recent NCI initiatives aim to support key steps in the intervention discovery and development process (see: Rapid Access to NCI Discovery Resources (R-A-N-D); Rapid Access to Intervention Development (RAID); Flexible System to Advance Innovative Research (FLAIR); and Molecular Target Drug Discovery grants (MTDDs)at: The above initiatives provide assistance for the most part to individual researchers. The present initiative has a very different organizational focus. We wish to bring together the basic research skills inherent in the academic institutions, the scientific expertise of industry, the interests of disease-oriented charities and non-profit groups, and the administrative support, resources, and years of discovery and development expertise of the DTP, DCTD, NCI. RESEARCH OBJECTIVES Background The cost of discovering and developing a drug to the point of filing a New Drug Application (NDA), which allows sale to the public, has been estimated to be as high as $800 million, and requires up to 15 years of research, clinical trials, and marketing. At the same time, scientific breakthroughs have revealed that many, if not all, human cancers can be classified into genetic subtypes, potentially decreasing the population of patients who may benefit from a rationally designed, targeted drug, diagnostic or imaging technology. This raises the possibility of creating "orphan status" markets, traditionally of less interest to large pharmaceutical companies. This concern, that "big pharma" may stand back from research in an "orphanized" cancer market, might be addressed by creating partnerships in which NCI leverages the risks of cancer intervention discovery and development for academic and industrial researchers. The NCI desires to catalyze the creation of these partnerships to realize the promise of the molecular revolution in cancer biology. In the Fall of 2001, the Office of Scientific Planning and Assessment (OSPA) convened a committee of NCI staff charged with outlining an implementation plan which would make the public-private partnership concept a reality. OSPA identified a potential model for NCI activities in the Industrial/University Cooperative Research Center (I/UCRC), an initiative originally developed by the National Science Foundation (NSF). The NSF I/UCRC Program was initiated in 1973 to catalyze the formation of long term partnerships among industry, academia, and government, particularly focused on engineering and materials science initiatives. The NSF invests in academic centers, which are the focus of these partnerships, to promote research programs of mutual interest to the members forming each partnership. The goals of this program are to contribute to the Nation's basic research infrastructure, and to enhance the intellectual capacity of the engineering workforce through the integration of research and education. The Centers are catalyzed by a small investment from NSF, which then adopts a supporting role in their development. The primary financial support for each Center comes from Center "members," derived mainly from the industrial sector. The NSF program offers five-year awards to Centers. This five-year period allows for the development of a strong partnership between the academic researchers and their industrial and government members. There are currently more than 50 Centers involving 750 faculty and almost 1,000 students. The Centers are supported by more than 700 partners ( The NCI modification of the NSF I/UCRC, the Academic Public-Private Partnership Program (AP4), constitutes a novel cooperative agreement mechanism for the NCI. AP4 features will include: o. An AP4 Center Director located at a United States university or non- profit institution applies for and coordinates the planning grant effort, and if successful in the subsequent Center application, coordinates all aspects of the Center. The Director will consult with Center members to define a research agenda focused on shared research interests, needs, and opportunities. o Biotechnology, pharmaceutical, non-profit, university and/or state and local government partners who are members of the Center, and who contribute financially to the operation of the Center. o A Steering Committee for each Center comprised of the membership of the Center which approves ongoing activities and recommends new projects, responding to current dynamic opportunities. o A membership agreement which serves as a formal operations document, and which specifies the structure and policies of the Center, including how the Center is governed, as well as the prospective management of intellectual property issues, publication procedures, and membership fees and rights. Different Centers may have substantially different agreements. o development of scientific expertise in research relevant to cancer intervention discovery and development at the academic level. o A strong research team capable of developing and operating an AP4. o Annual formal evaluations of the organization of the partnership compiled by an individual evaluator who works with the AP4 Director but is independent of the Center. o Facile access to the development contract resources of the Developmental Therapeutics Program (DTP) (formulation, bulk synthesis, pharmacology, toxicology) for promising lead compounds approved by the Center Steering Committee which meet NCI criteria for interest. Criteria for NCI interest would follow the same guidelines as those compounds or biological constructs presented to the Drug Development Group (DDG) (See: o Investigational New Drug (IND)-filing assistance through the Cancer Therapy Evaluation Program (CTEP) for an NCI-based clinical trial or a Principal Investigator-based trial will be afforded on a case-by-case basis. This may involve assistance in putting together IND's when held by the originating Center or assumption of the IND if the agent is to be studied more broadly in NCI's existing early clinical trials groups. The AP4 Center must be based at an academic or non-profit institution, and will include a combination of biotech, pharmaceutical, non-profit organizations, the NCI, and other government agencies as partners, each with an interest in translating novel anticancer therapeutic, prevention, diagnostic, and imaging interventions from the laboratory to the clinic. Each Center partner might contribute expertise in a different functional area of the intervention discovery and development process. Alternatively, partners with expertise in overlapping disciplines could agree to support one aspect of a discovery and development program; the actual roles and goals of each Center's members will be articulated by the AP4 Center Director and included in the membership agreement. There will be three or more selected research projects, which are new collaborative efforts, of interest to the partners, to be conducted at the institution, and upon which review of the Center application will be partially based. Existing partnerships may apply provided that the selected projects are new to the partnership. Major criteria for review will encourage that the research approach take advantage of the latest technologies, and include projects with a focus on malignancies that are underserved or on biologically defined subsets of more common tumor types. The goal of each selected project will be the development of a new anticancer therapeutic, preventive, diagnostic or imaging agent. AP4 Center awards will be for a period of five years. The Centers will be funded initially with $450,000 per year (total direct costs including third party F and A) by NCI, with a minimum of $300,000 per year (total) funds coming from Center members. For Centers with combined funds from partners of at least $450,000, the NCI's annual contribution will increase to $600,000 (total direct costs including third party F and A). NCI expects the awardees will be able to compete for a second five-year award of $100,000 - $200,000 (direct costs) per year, which could be made to Centers successful in meeting their established goals. After ten years, it is expected that Centers which continue to operate would be fully supported by industrial, non-profit, academic, other (non-NIH) Federal agency, and/or state and local government partners. For more details on funding and other aspects of the AP4 Center, please refer to Objectives and Scope The One-year Planning Grant for an AP4 Center This RFA requests applications for the one-year planning grant. The $50,000 (total direct costs including third party F and A) one-year planning grant, which will be competitive and peer-reviewed, will be used by the proposed AP4 Director to study the feasibility of developing the pharmaceutical/non-profit/academic interaction necessary to establish or significantly expand existing partnerships, and will lead to a determination of whether or not to apply for an AP4 Center. The planning grant period will include a meeting that brings together potential members to explore opportunities, discuss how intellectual property issues will be handled, and establish a research plan. The ideal planning grant applicant will be based at an academic or non- profit institution with a clear track record of funded research in cancer biology. The application should identify the overall theme and/or the disease(s) to be studied. Letters of interest in a potential Center from at least two potential members must be included in the application for the planning grant. These letters will not be viewed as full or formal commitments, but as a basis for further discussion. NCI recognizes that the final AP4 Center application may contain commitments of a subset of these, or additional potential members. Only awardees of a planning grant will be eligible to submit an application for the AP4 Center. Elements of a successful planning grant application will include: o A description of the scientific and managerial experience of the proposed AP4 Director, and the names and research expertise of participating researchers; o A brief description of the capabilities of the institution, including faculty and infrastructure, and the commitment of the institution to the proposed Center; o A brief description of the proposed organization of the Center: management plans, staffing, budget, and operational procedures; o The description of the process and criteria that will be used during the planning period to recruit partners and select projects for the Center application. o A description of the process to be used to select the Center evaluator. The evaluator will be responsible for conducting surveys on Center performance, and the progress of projects. Evaluators must be external to the Center and may be retained on a contractual basis; o A one to two page summary for each of at least three sample initial projects involving orphan malignancies, addressing how the projects would impact the diagnosis, prevention, imaging or treatment of a specific cancer, and how the areas of research are appropriate to the institutional environment; o Letters from at least two potential Center members from biotech, pharmaceutical, academic, non-profit organization, or non-NIH government agencies stating that the proposed research agenda of the Center is concordant with the organization and that the organization would consider joining if the Center were formed. The AP4 Center Application It is anticipated that the actual Center application will be written during the one-year planning grant period and will be submitted at the end of this period It is anticipated that several months will elapse in between the submission of the Center application and the award. Details on the requirements of the AP4 Center application can be found at: Definitions Awardee The academic or non-profit institution to which the AP4 U56 is awarded. Academic Public Private Partnership Program (AP4) a partnership based at an academic or non-profit institution comprised of academic, industrial, NCI, state and local government entities, and non-profit groups engaged in the discovery and development for eventual clinical evaluation of novel anticancer therapeutic, prevention, diagnostic, and imaging interventions. AP4 Director (AD) The scientist who conceives of and administers the Center. The AD is responsible for and accountable to the applicant institution and to the NCI for the performance and proper conduct of the AP4 Center in accordance with the terms and conditions specified in this RFA. Center Application successful awardees of a planning grant will be eligible to submit an application for an AP4 Center. Center Evaluator an individual who is independent of the Center and who is responsible for surveying, collecting and distributing member feedback regarding their satisfaction with the Center and reporting on the status of all Center projects as presented to the Steering Committee. Membership Agreement a document that establishes a framework for the relationship between all partners. All partners must agree to terms of the agreement that spells out issues of intellectual property, publication rights, membership fees, changes in membership, creation of the Steering Committee, and evaluation metrics for the Center NCI Program Coordinator A scientist from the NCI extramural program staff, appointed after award, who participates as a member of the Steering Committee, interacts scientifically with the Center and facilitates the role of NCI as a partner in the Center. Orphan Disease - The disease or condition for which the intervention is intended affects fewer than 200,000 people in the United States per year as defined by the FDA. (See paragraph 8i in: Planning Grant the planning grant supplies funding for a period of one year to the proposed AP4 director's institute to study the feasibility of developing the interactions necessary to establish and support an AP4 Center. One activity during the planning grant year is the planning and holding of a meeting which brings together potential partners to discuss research opportunities and define a research plan for each of the proposed projects. Partner a biotech, pharmaceutical company, academic or non-profit organization or non-NIH government agency that contributes financially to the AP4 Center. Each partner furthermore contributes to the success of the Center by selecting a representative to actively participate in Steering Committee meetings. Project a scientific study supported by the AP4 involving a cancer- relevant molecular target or an intervention such as a therapeutic, diagnostic, preventive or imaging agent. Steering Committee (SC) comprised of representatives from the Center membership, the NCI Program Coordinator, and chaired by the AP4 Director. The SC reviews all project status reports and makes go/no go decisions and recommends new projects. The SC may shift funds from one project to another, and select candidate molecules for possible clinical development. MECHANISM OF SUPPORT This RFA will use the NIH (U56) award mechanism. As an applicant you will be responsible for planning, directing, and executing the proposed project. The anticipated award date is June 2004. This RFA uses just-in-time concepts. It also uses the modular format budget (see The NIH (U56) is a cooperative agreement award mechanism 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, as described under the section "Cooperative Agreement Terms and Conditions of Award" FUNDS AVAILABLE The NCI intends to commit approximately $1.125 Million in FY 2004 to fund up to 15 new planning grants in response to this RFA. An applicant may request a project period of one year and a budget of $50,000 total direct costs which includes third party F and A. Although the financial plans of the NCI provide support for this program, 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) only if your institution has the following characteristic: o Public or private domestic degree-granting academic institutions, such as universities and colleges; o Non-profit domestic organizations; o Foreign institutions are not eligible. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, experience in cancer intervention discovery and development, 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 The proposed Center's objectives and goals should be relevant to and compatible with the NCI's mission in cancer intervention as stated in this RFA. The application shall include letters from at least two potential partners and address at least three new potential projects. Partnerships already in existence are eligible to apply provided the potential projects are new to the partnership. Applicants should describe their plans to accommodate the stated AP4 Center requirements, criteria, and working with NCI staff. Non-profit applicants should either have a formal relationship, such as joint faculty appointments, with degree-granting academic institutions or identify a degree-granting institution as a partner. Planning grant recipients shall organize and hold a meeting of potential AP4 Center partners to explore opportunities, discuss how intellectual property issues will be handled, and establish a research plan. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. Failure to abide by any of the Terms and Conditions of Award pertaining to awardee responsibilities stipulated in this Section may result in a reduction of funding, withholding of support, suspension or termination of the award. These special Terms and Conditions of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, DHHS Grant Administration Regulations at 45 CFR parts 74 and 92, and other DHHS, PHS, and NIH Grant Administration Policy Statements. The administrative and funding instrument used for this program is a cooperative agreement (U56), 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 for the project as a whole, although specific tasks and activities in carrying out the studies will be shared between the awardee and the NCI Program Coordinator. 1. Awardee Rights and Responsibilities The AP4 Director will have primary authority and responsibility to define objectives and approaches. She/he will assume responsibility and accountability to the applicant organization and to the NCI for performance and proper conduct of the activities supported in the AP4 planning grant in accordance with the TERMS AND CONDITIONS OF AWARD. 2. NCI Staff Responsibilities NCI will participate as a partner in the planning grant and will be represented by an NCI Coordinator, who will have substantial scientific/programmatic involvement during the conduct of the project that is above and beyond normal program stewardship, as described below. The NCI Program Coordinator is a scientist from the NCI extramural program staff, appointed after award, who participates as a member of the Steering Committee, interacts scientifically with the Center and facilitates the role of NCI as a partner in the Center. During performance of the award, NCI may provide appropriate assistance by participating in the design of activities; advising in the selection of sources for resources, staff, etc.; and advising in management and technical performance. It is not NCI's role to assist in the writing of the AP4 application, to assist in the actual planning or conduct of the partnering meeting, or to identify potential partners. In all cases, the role of NCI will be to facilitate but not to direct activities. An NCI Program Director will perform normal program stewardship responsibilities for this award. 3. Collaborative Responsibilities The Collaborative Responsibilities are based on the premise that the AP4 is a unit consisting of an AP4 Director, Principal Investigators, their respective programs, and an NCI Coordinator, which functions as a unit as specified in this RFA. Foreign institutions may be participants as potential Center members but not as the awardee institution, and their scientists may not serve as the AP4 Director. A Steering Committee (SC), comprised of the AP4 Director, representatives from the Center membership, and the NCI Program Coordinator as voting members, is the governing body of the AP4, reviews all project status reports and makes go/no go decisions and recommends new projects. The SC may shift funds from one project to another, and select candidate molecules for possible clinical development. The SC is chaired by the AP4 Director. WHERE TO SEND INQUIRIES We highly recommend that applicants for an AP4 planning grant review the requirements for the AP4 Center application found at We also strongly encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants and their potential partners. 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: Jill Johnson Developmental Therapeutics Program, DCTD National Cancer Institute Building EPN, Room 8020 Bethesda, MD 20892 Telephone: (301) 496-8720 FAX: (301) 402-0831 Email: o Direct your questions about peer review issues to: Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: o Direct your questions about financial or grants management matters to: Ms. Kelli Oster Grants Administration Branch Office of Management, OD, NCI Executive Plaza South - Room 243 6120 Executive Boulevard Bethesda, Maryland 20892 Telephone: (301) 496-8627 Fax: (301) 496-8601 E-mail: LETTERS 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 AP4 Director o Names 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 a subsequent application, the information that it contains allows NCI staff 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: Jill Johnson Developmental Therapeutics Program, DCTD National Cancer Institute Building EPN, Room 8020 Bethesda, MD 20892 Telephone: (301) 496-8720 FAX: (301) 402-0831 Email: SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 (rev. 5/2001) at includes step- by-step guidance for preparing modular grants. Additional information on modular grants is available at 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: 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) At the time of submission, two additional copies of the application must be sent to: Referral Officer National Cancer Institute 6116 Executive Blvd, Room 8041, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for express/courier service) APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL CANCER INSTITUTE WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) ( This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice APPLICATION PROCESSING: Applications must be received on or before 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. 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. 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. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to an RFA, it is to be prepared as a NEW application. That is the application for the RFA must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes. While the investigator may still benefit from the previous review, the RFA application is not to state explicitly how. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCI. 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 Division of Extramural Activities of the NCI 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 REVIEW CRITERIA The goals of NIH-supported research 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 the application in order to judge the likelihood that the proposed plan will have a substantial impact on the 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 the application's overall score, weighting them as appropriate for each application. The 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, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. SIGNIFICANCE: Does the application demonstrate the ability to plan and organize an AP4 Center within the one-year planning period? Does the application propose new partnerships and/or significant expansion of existing partnerships? Do the sample proposed projects address one or more orphan malignancies as defined in this RFA? APPROACH: Are the proposed strategies for the planning year, including the potential partners meeting, appropriate and adequately developed for establishing new partnerships and/or significantly expanding existing ones? Are the proposed processes and criteria for organizing the future Center and selecting partners and projects adequate, well integrated, and appropriate for the orphan cancer diseases(s) to be addressed? Do letters of interest from potential AP4 Center members support the priorities and objectives of the proposed planning process? Are the proposed methods for securing resources (space, budget, staffing) for the future Center adequate? INNOVATION: Does the proposed AP4 Center involve novel concepts, approaches, or methods? Does it involve new partnerships or new projects for an existing partnership? INVESTIGATOR: Does the proposed AP4 director have strong scientific and administrative leadership abilities? Are the roles of other proposed researchers appropriate to their qualifications and experience? Are the sample projects appropriate to the experience level of the AP4 director and other researchers (if any)? Do the researchers involved in the planning grant represent an appropriate range of disciplines? ENVIRONMENT: Does the scientific environment in which the proposed work will be done contribute to the probability of success? Is there evidence of strong institutional commitment and support? RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 21, 2003 Application Receipt Date: November 20, 2003 Peer Review Date: February 2004 Earliest Anticipated Start Date: June 2004 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Merit (as determined by peer review) o Availability of funds o Programmatic priorities. REQUIRED FEDERAL CITATIONS 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 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. 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 AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance at and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at 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.

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