SHARED PATHOLOGY INFORMATICS NETWORK Release Date: March 27, 2000 RFA: CA-01-006 National Cancer Institute Letter of Intent Receipt Date: June 19, 2000 Application Receipt Date: July 24, 2000 PURPOSE The Resources Development Branch of the Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI) invites applications for cooperative agreements (U01) from consortia (composed of a parent institution or organization and 2 or 3 additional institutions or organizations) capable of working together to form a Shared Pathology Informatics Network (hereafter called Network ). The objective of this initiative for a Shared Pathology Informatics Network is to create a model Web-based system to access data related to archived human specimens at multiple institutions. The data to be accessed will be derived from existing medical databases. The ability to automatically access information from medical databases is the first step toward the long-term goal of developing informatics systems to support NCI’s efforts to improve researchers access to human specimens and clinical data. The system to be developed by the Network should be able to automatically respond to authorized queries by identifying, obtaining and returning data for those cases that meet defined search criteria. The patient’s name and other identifying information must be encrypted or otherwise modified to protect patient confidentiality and to comply with applicable confidentiality regulations. In addition to improving access to clinical data, the system is expected to provide researchers with the means to quickly identify and determine the availability of archived specimens with defined characteristics. The proposed system is described in more detail in the Research Objectives and Applications Procedures Sections of this RFA. 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, Shared Pathology Informatics Network, is related to the priority area of Cancer. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by U.S., Canadian and Mexican 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. Foreign institutions from countries other than Canada and Mexico are excluded from participation in this RFA. Minority individuals, women, and persons with disabilities, are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be the cooperative agreement (U01), an "assistance" 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. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award. The total project period for applications submitted in response to the present RFA may not exceed 5 years. The anticipated award date is April, 2001. Awards and level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. The RFA is a one-time solicitation. However, the model system to be developed as part of this initiative is expected to form the basis for subsequent NCI efforts to provide specimen and specimen-related data resources to support cancer research. FUNDS AVAILABLE The NCI intends to commit approximately $2.75 million (total cost) in FY 2001 and expects to fund 2 consortia for up to 5 years in response to this RFA. The total intended set-aside covering direct plus facilities and administrative (F&A) costs to support 2 consortia over the 5-year period is $13.5 million (total cost). Because the nature and scope of the applications may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NCI include 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. RESEARCH OBJECTIVES Background Pathology laboratories contain a wealth of specimen-related data. Most pathology departments have at least 10 years of electronically archived pathology reports containing diagnostic, demographic and clinical information. While this valuable research information is stored electronically, most institutions limit the ability for unlimited searches of electronic patient data to a small number of individuals. Internet technology provides new opportunities for accessing information related to tissue specimens. It is now feasible to search the electronic archives of multiple institutions for specimen-related data via Internet queries. Security protocols can automatically encrypt or modify patient identifiers to ensure the confidentiality of patient-related data. In such a system, the information systems at participating institutions respond to researcher-initiated queries with a listing of specimens and related data that meet the query criteria. Including multiple institutions allows access to many more cases than are presently available in any single tissue resource. The need for expensive centralized tissue banks would be greatly reduced if information Networks were developed that could utilize existing data resources. We anticipate that the model system proposed for development under this RFA will eventually see broader application. One of the efforts of this Network will be to define generalizable and flexible procedures for adding additional institutions to an existing network, systems for creating new networks, and procedures for interfacing with other networks. Objectives and Scope The objective of this initiative, the Shared Pathology Informatics Network, is to create a single Web-based system capable of requesting and receiving clinical data related to archived specimens at multiple institutions. Searchable databases with patient data exist at hospitals and medical institutions. Increasingly sophisticated software tools are now available that can facilitate communications among disparate computer systems, even among those that employ different architectures and search strategies. The Shared Pathology Informatics Network will employ Internet technology and these software tools to process researcher-initiated queries on multiple institutional databases. Search engines that are integral to the pathology informatics systems at each institution will interrogate the database and produce query replies. The query replies will then be translated into a structured reply format, standardized for all the institutions in the Network. These replies will be merged into a single document that will be sent electronically to the researcher who placed the query. A Coordinating Committee will plan the Network (see Terms and Conditions of Award ). Over the five year project period, the Network will develop and test the communications protocols needed to access data by means of Internet queries distributed simultaneously to multiple institutions. The data to be searched will include, at a minimum, patient demographics, vital status, clinical history, histologic information, and, whenever possible, outcome data and information related to recurrence and treatment. Data returned by participating institutions will be automatically collated and returned to the requestor as a structured report. The Network will also define generalizable and flexible procedures that should allow more institutions to be added to an existing network and developing additional networks. The following timeline for the Network divides the development of the system into three phases: an organization phase; a component selection, development and implementation phase; and a testing and validation phase. It provides a general guide to understanding the broad objectives of the Network. a. Organization Phase (Years 1 & 2): In the Organization phase, the Coordinating Committee will meet to discuss plans from consortia and to agree on a general implementation plan. In the organization phase, common data elements will be chosen, and work will be started on choosing coding rules to automatically translate free text pathology reports into a standard nomenclature. The Coordinating Committee will develop a standard query reply format so that query replies returned from multiple institutions can be seamlessly merged into a single coherent report. The Coordinating Committee will develop strategies to preserve patient confidentiality. It must also identify those data elements that must be encrypted, truncated or deleted in order to protect patient identity. b. Component Selection, Development and Implementation Phase (Years 2-3.5): In this phase the Coordinating Committee will select and develop mechanisms to distribute queries to Network institutions via the Internet. This includes defining how queries will be processed and distributed to the consortium institutions; selecting software to provide the security function that authenticates queries and safely allows queries through the Consortium institution fire walls; and selecting handshaking software to establish connections to the existing data systems at each participating institution. The handshaking software is the link that permits queries to enter institutional databases as though they originated within the institution. The Network will implement protocols to securely transmit query results over the Internet and protocols to ensure patient confidentiality using automatic encryption, deletion or truncation of sensitive or identifying information. Network institutions will obtain approval from institutional IRBs for access to patient information. c. Testing and Validation Phase (Year 3.5-5): In this initial testing phase of the system, participants should demonstrate that all components work at each institution. The consortium will correct software and hardware errors and improve performance of the system. The Coordinating Committee will develop operation and repair protocols for the system. In the alpha test phase, the performance of the Network will be evaluated by the Coordinating Committee. In the beta test phase, queries from selected members of the research community will be solicited, the effectiveness and ease of use of the system evaluated, and the system optimized. Each phase contains research objectives (milestones) that must be accomplished before succeeding phases can be achieved. Milestone 1 is the selection of a set of common data elements that can be searched in every Network institution. Milestone 2 is the creation of a set of parsing rules that can be implemented in a software application to automatically map concept terms contained in surgical pathology report free-text to one or more common medical terminologies (e.g. SNOMED or UMLS) with implementation of the parsing rules in a way that preserves the conceptual content of the free-text diagnosis with high accuracy. Milestone 3 is the construction of a workable schema in which useful patient-related information can be transmitted in Network query replies in a manner that is compliant with applicable local, state and federal regulations and that is acceptable to the institutional IRBs. Applications are requested from preformed consortia, each consisting of 3-4 institutions or organizations. Each application should propose one Principal Investigator from the parent institution and one principal investigator from each of the other consortial sites. Participating institutions must demonstrate technical expertise and resources sufficient to further the objectives of the Network and to meet the specific requirements listed in the Special Requirements and Application Procedures Sections. The proposed consortium must include institutions that utilize different pathology information systems. The availability of several different commercial information systems should facilitate the development of procedures for adding institutions and developing additional networks. Each participating institution must have an existing pathology information system that can store and retrieve patient information, including demographics and pathology reports that are linked to existing archived specimens. Access to hospital clinical data and cancer registry data, in addition to pathology data, is strongly encouraged and should significantly improve the competitiveness of an applicant consortium. Applicants should carefully follow the additional points listed in the Application Procedures Section. SPECIAL REQUIREMENTS Terms and Conditions of Award The following Terms and Conditions of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations in 45 CFR Parts 74 and 92 and other HHS, PHS and NIH grant administration policies. The administrative and funding instrument used for this program will be the cooperative agreement (U01), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the 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 studies will be shared among the awardees and the NCI Program Coordinator, as described in these terms and conditions. 1. Awardee Rights and Responsibilities Awardees will have primary and lead responsibilities for the project as a whole, including collaborating with other awardees, defining objectives and approaches, planning, implementing, and measuring overall progress, preparing publications, establishing testing and implementing quality assurance measures for all aspects of the operation of the Network. Awardees will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. PIs are also responsible for maintaining communications with the other PIs, with the Program Coordinator and with others, including vendors, members of Institutional Review Boards, administration officials from any of the consortium members, and any anyone else whose involvement is germane to the successful completion of the model system. The PI may be required, at the discretion of the Chair, to submit a progress report at any meeting of the Coordinating Committee. PI’s are responsible for ensuring the full cooperation of his/her consortium institutions in reaching the following milestones: Milestone 1: the selection of a set of common data elements that can be searched in every Network institution. Milestone 1 should show satisfactory progress by the end of phase 1. Milestone 2: the creation of a set of parsing rules that can be implemented in a software application to automatically map concept terms contained in surgical pathology report free-text to one or more common medical terminologies (e.g. SNOMED or UMLS) with implementation of the parsing rules in a way that preserves the conceptual content of the free-text diagnosis with high accuracy. Milestone 2 should show satisfactory progress by the end of phase 2. Milestone 3: the construction of a workable schema in which useful patient-related information can be transmitted in Network query replies in a manner that is compliant with applicable local, state and federal regulations and that is acceptable to the institutional IRBs. Milestone 3 should show satisfactory progress throughout the Term of Award. 2. NCI Staff responsibilities The Program Coordinator will be designated by the Associate Director of the Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis (hereafter called Associate Director ). The Program Coordinator will coordinate the development and operations of the Network and will facilitate the complex interactions of the various participants. These activities include: ensuring the development of a standardized report format, including common data elements; ensuring that network protocols, software and other resources previously developed by or licensed to the NCI will be made available to the Shared Pathology Informatics Network; assisting with testing and validating the systems developed by the Network; assisting in the development of consistent operating policies for the Network; and assisting the consortia in meeting specified milestones The Program Coordinator will also help ensure smooth interactions among the cooperating organizations, facilitate the exchange of information among the cooperating organizations and serve as a voting member of the Network Coordinating Committee. The Program Coordinator attends and participates fully but not as the chair, at all meetings of the Coordinating Committee. The Associate Director will select a panel of program staff to review and evaluate satisfactory progress toward completion of the three milestones described in Awardee Rights and Responsibilities. The NCI reserves the right to withdraw funding to one or more consortia if satisfactory progress toward completion of the milestones is not achieved. 3. Collaborative Responsibilities The NCI Program Coordinator and the Principal Investigators for the U01 awards will be responsible for forming a Coordinating Committee to oversee the operation of the Network. The Coordinating Committee will act as the governing body of the Network and all participants are bound by its actions. An arbitration system, as detailed below, will be available to resolve scientific/programmatic disagreements which may arise between the NCI and the Coordinating Committee. Coordinating Committee meetings are to review, assess and facilitate progress by participating institutions; to establish policies and priorities; and to solve problems. The Coordinating Committee will develop a strategy to meet the milestones described in Awardee Rights and Responsibilities. The Coordinating Committee will initially consist of the following voting members: the consortium principal investigators for the parent institutions, the principal investigators for each funded consortial site, and the Program Coordinator. Additional voting members may be added at the first or subsequent meetings by a unanimous vote of the Coordinating Committee. A representative from the NCI Office of Informatics may attend Coordinating Committee meetings as a non-voting consultant. The role of the informatics representative is to provide advice on implementation of software developed by the NCI and information on ongoing or planned NCI informatics efforts relevant to this program. The Coordinating Committee is responsible for establishing uniform procedures related to any and all aspects of implementation of the Network. At its initial meeting it will review and implement as appropriate, the plans and timelines for developing the Network that were proposed in applications from the participating consortia. This will ensure that the efforts of individual awardees are compatible with the overall goals of the RFA. It will also elect a Chair (who cannot be the Program Coordinator) and establish the Chair’s term in office. The Chair of the Coordinating Committee is responsible for maintaining oversight and assuring progress, for developing agendas and for chairing Coordinating Committee meetings. The Program Coordinator is a voting member of the Coordinating Committee. The Coordinating Committee will meet three times in the first year and at least twice a year thereafter and may hold additional meetings and conference calls as necessary. Meetings may be held at any of the participating organizations or another convenient location. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NCI may be brought to arbitration. An arbitration panel will be constituted, consisting of three members: one selected by the Coordinating Committee (with the NCI member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NCI, and the third member selected by the two previously 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. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators may also obtain copies of the policy from the program staff listed under INQUIRIES. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. LETTER OF INTENT Prospective applicants are asked to submit, by June 19, 2000, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, identities of other key personnel and participating institutions, and number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information allows NCI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Jules Berman listed under INQUIRIES by the letter of intent receipt date listed. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, E-mail: grantsinfo@nih.gov. For those applicants with internet access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm To ensure appropriate review and facilitate development of the Network, the following issues should be addressed in each application. 1. Applicants will propose a plan for implementing the Network. In the plan, they will describe their approach to achieving each component task included in Objectives and Scope , indicate problems which might arise during the completion of the task, and how they might be solved, and propose a timeline for completing the critical tasks. The timeline may differ from the timeline suggested in Objectives and Scope , but must meet the milestones specified in Terms and Conditions of Award. This plan permits the applicants to provide their own concept for developing the Network, while staying within the overall scope and purpose of the RFA. It should be understood that the final plan for implementation will be developed and approved by the Coordinating Committee. In order to abide by the Terms of Award, applicants must clearly indicate their willingness to serve on the Coordinating Committee, to be bound by its decisions and to participate in all activities described in "Terms and Conditions of Award". 2. Applicants will describe the information and specimen resources that are available at each consortium institution. This will include the laboratory information system (LIS) and, if applicable, the hospital information system (HIS). Because the Network is being developed as a flexible model that will accommodate a diversity of systems, each consortium will include several different LIS or HIS systems. Where applicable, the ability to access Cancer Registry and/or other data should also be described. Describe the types of queries that are currently supported and conducted, and the extent to which such queries can access clinical as well as pathological data. Describe the institutional pathological and clinical datasets, and provide the number of surgical pathology records, the range of dates covered by the datasets, the rate of record accrual in the data sets, and the data fields included in the datasets. 3. Applicants will provide a measure of the completeness and validity of their data sets. Completeness refers to whether a data element in a given data record contains data. Validity refers to whether the data element contains sensible information. For instance, a complete and valid date-of- birth data element should not be empty and should contain a date consisting of day, month and year, and the date should precede the submission date for the surgical pathology report. Examples of data elements generally included in surgical pathology reports are: case identifier, patient identifier, patient date of birth, patient gender, ethnicity, date specimen received, date report issued, type of specimen, clinical information (usually a brief clinical history), and microscopic diagnosis. Applicants must devise an assessment that quantitates the percentage of their reports that are complete and valid for each of the data elements in their institution=s surgical pathology reports. Applicants should also justify the methodology they employed in the assessment. 4. Applicants must provide evidence of their expertise in pathology-related informatics. Where informatics support resides outside the pathology department, applicants must demonstrate that an established cooperative working relationship has existed. 5. Although we do not anticipate that tissues will be distributed to researchers during the five year award period, one of the key purposes of this Network will be to lay the groundwork for future initiatives that will distribute tissue specimens. Therefore, applicants will include a statement from each consortium institution regarding its willingness to provide archived specimens and related data to researchers within and outside the consortium institutions. Include, if applicable, past history of the institution in providing specimens for research. The statement of willingness is requested to allow the NCI to evaluate whether Network institutions would participate in a subsequent virtual resource to make archived tissue and data accessible to researchers. The NCI understands that these arrangements could be effectively negated by circumstances beyond the control of the participating institutions. 6. Applicants will estimate the percentage of surgical pathology records associated with retrievable paraffin blocks, and confirm the availability of the paraffin-archived tissues and their willingness to provide them to researchers. Applicants must obtain full board IRB approval for the Resource. Applicants must complete the Human Subjects section of the PHS 398 grant application, including plans to protect patient confidentiality, and if required by their IRB, procedures to obtain informed consent for prospective procurement of patient data. The travel budget should include funds for travel by two people to three meetings of the Coordinating Committee in the first year of the grant and two meetings of the Coordinating Committee in subsequent years. The RFA label available in the PHS 398 (rev.4/98) 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 sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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 (20817 for express service) At the time of submission, two additional copies of the application must also be sent to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Blvd., Room 8062, MSC 8239 Rockville, MD 20852 (express courier) Bethesda MD 20892-8239 Telephone: (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov Applications must be received by July 24, 2000. 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 announcement 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 an application must follow the guidance in the PHS Form 398 application instructions for the preparation of revised applications, including an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and for responsiveness by the National Cancer Institute. 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 NCI in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and 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, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria The goal of NIH-supported resources is to facilitate research that advances the understanding of biological systems, improves the control of disease, and enhances 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 Network would have a substantial impact on the pursuit of these goals. Each of the criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a competitive 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. (1) Significance: Will the proposed approach advance the ability of the research community to access clinical information linked to archived tissue specimens? Will the approach facilitate progress in the field of specimen- related informatics? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and propose alternative tactics? (3) Innovation: Does the project employ creative approaches and methods for the development and implementation of the Shared Pathology Informatics Network? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other consortium participants? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed Network take advantage of unique features of the institutional environment or employ useful collaborative arrangements? Is there evidence of institutional and departmental support for the effort? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. In addition does the population represent an appropriate age distribution? o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Additional scientific/technical merit criteria: The quality of the pre-existing hospital information system (HIS) and laboratory information system (LIS) of the institutions within each applicant consortia. This would include the completeness, quality, extensiveness, quantity and accessibility of clinical and pathological reports included in HIS and/or LIS datasets and of associated archived specimens. The ability to access clinical information in addition to that contained in pathology reports, particularly clinical data contained in Cancer Registries or some other institutional dataset that includes clinical data and outcome information. The accessibility of archived paraffin-embedded specimens referenced in the surgical pathology report dataset. AWARD CRITERIA Applications recommended by the National Cancer Advisory Board will be considered for award based upon (a) scientific and technical merit; (b) program balance, including in this instance, sufficient compatibility of features to make a successful collaborative program a reasonable likelihood; and (c) availability of funds. SCHEDULE Letter of Intent Receipt Date: June 19, 2000 Application Receipt Date: July 24, 2000 Peer Review Date: October or November 2000 NCAB Review Date: February, 2001 Earliest Anticipated Start Date: April 1, 2001 INQUIRIES Written and telephone inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Jules J. Berman, Ph.D., M.D. Resources Development Branch, Cancer Diagnosis Program National Cancer Institute Executive Plaza North, Room 700 6130 Executive Boulevard, MSC-7420 Bethesda MD 20892-7240 (Rockville, MD 20850 for express/courier service) Telephone: (301) 496-7147 FAX: (301) 402-7819 Email: bermanj@mail.nih.gov Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116, Executive Blvd., Room 8062, MSC-8239 Bethesda MD 20892-7399 (Rockville, MD 20852 for express/courier service) Telephone (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov Direct inquiries regarding fiscal matters to: Ms. Barbara A. Fisher Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard, MSC 7150 Bethesda, MD 20892-7150 (Rockville, MD 20850 for express/courier service) Telephone: (301) 496-8626 FAX: (301) 496-8601 Email: stones@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.394 Cancer Detection and Diagnosis. 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 Parts 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 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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