DIRECTOR'S CHALLENGE: TOWARD A MOLECULAR CLASSIFICATION OF TUMORS Release Date: January 20, 1999 RFA: CA-98-027 P.T. National Cancer Institute Letter of Intent Receipt Dates: March 23, 1999; October 5, 1999 Application Receipt Dates: April 26, 1999; November 16, 1999 PURPOSE The Director of the National Cancer Institute (NCI) challenges the scientific community to harness the power of comprehensive molecular analysis technologies to make the classification of tumors vastly more informative. This challenge is intended to lay the groundwork for changing the basis of tumor classification from morphological to molecular characteristics. The NCI Director invites investigators to form multi-disciplinary research groups [National Cooperative Tumor Signature Groups (NCTSGs)] and to submit applications proposing the exploitation of one or a related set of comprehensive molecular analysis technologies for the analysis of tumor specimens. The NCTSGs will be expected to define comprehensive profiles of molecular alterations in tumors that can be used to identify subsets of patients. These molecular profiles will provide the basis for future studies to validate the clinical utility of molecular-based classification schemes. To achieve these goals, applicants may propose to develop comprehensive molecular profiles using DNA, RNA or protein-based technologies. A further goal of this initiative is the development and implementation of a plan for timely release of the extensive data sets expected to result from these projects. Access to these information rich data sets will benefit the entire cancer research community and facilitate rapid progress toward achieving the goals of the NCI. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Director's Challenge: Toward a Molecular Classification of Tumors, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800), or at http://www.crisny.org/health/us/health7.html ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign non-profit and for-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and Local governments, and eligible agencies of the Federal Government. NCTSGs may be formed by investigators from within a single institution. However, collaborations between companies developing molecular technologies and other institutions with clinical resources and cancer expertise are strongly encouraged. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for this program will be through the National Institutes of Health (NIH) cooperative agreement grant (U01) and research project cooperative agreement grant (U19) mechanisms. Applications for U01 support follow an R01 application format while applications for U19 support have a program project grant (P01) structure and follow a P01 application format. Like the P01, the U19 is an assistance award for the support of a broadly based multidisciplinary research program that has a well-defined central focus or objective (see APPLICATION PROCEDURES and REVIEW CONSIDERATIONS sections below for additional information specific to the multi-project format of the U19 application). The cooperative agreement (U01/U19) is an "assistance" mechanism in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the research. Under the cooperative agreement mechanism, the NIH purpose is to facilitate and/or coordinate the activities of the successful grantees, but not to assume direction, prime responsibility, or a dominant role in grant related activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed under the section "Terms and Conditions of Award". The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award dates are September 30, 1999 (1st application receipt date) and July 1, 2000 (2nd application receipt date). FUNDS AVAILABLE The NCI intends to commit approximately $10 million for the two application receipt dates to fund a total of eight to ten new grants in response to this RFA. 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. This RFA is a one-time solicitation. At this time, the NCI has not determined whether or how this solicitation will be continued beyond the present RFA. RESEARCH OBJECTIVES Background Since its beginnings as a scientific discipline, diagnostic pathology has been based on tumor morphology, the microscopic appearance of tumor tissue. Tumor morphology has served as the basis of tumor classification. Advances in tissue fixation, staining and imaging technologies have resulted in increasingly informative images that have permitted substantial refinements in diagnostic criteria for many cancers. Current classification schemes have serious limitations, however. They often cannot discriminate between tumors with similar histopathologic appearances that will follow significantly different clinical courses. The Director of the National Cancer Institute therefore invites the scientific community to exploit contemporary molecular analysis technologies to develop vastly more informative tumor classification systems. This challenge is intended to lay the groundwork for changing the basis of tumor classification from morphological to molecular characteristics. The Director's Challenge is based on the assumption that a comprehensive knowledge of the molecules, or a relevant subset of molecules, expressed in a tumor can be much more informative clinically than the morphological characteristics of the tumor. The knowledge that a specific molecular profile correlates with important clinical parameters should allow physicians to base management decisions on the molecular characteristics of an individual patient's tumor. Molecular profiles should also improve a physician's ability to determine the primary tumor site for tumors of unknown origin at the time of their detection. The application of high-throughput technologies to human tumors should make it possible to generate comprehensive molecular profiles. However, to date, the technologies have primarily been applied to the analysis of model systems, cell lines or lower eukaryotes. A few of the most mature technologies are now being applied to the analysis of clinical tissue specimens. For example, serial analysis of gene expression (SAGE) has been applied to the analysis of gene expression patterns in colon tumors, lung tumors and tumors from several other sites. Studies have been initiated to correlate gene expression patterns determined by SAGE with clinical parameters. Oligonucleotide and cDNA arrays are being used to analyze gene expression in colon, breast, and certain other tumors. Although these and other early studies are demonstrating the potential power of these technologies, the extensive research needed to be able to routinely apply molecular-based strategies to actual tumor specimens is just beginning. This is an opportune time for NCI to facilitate the application of these technologies to the analysis of tumor specimens. The technologies have developed to the point where translation to analysis of tumor specimens is feasible. The Cancer Genome Anatomy Project (CGAP) and other research efforts are providing the resources and reagents needed to facilitate these efforts. This initiative is designed to bring together the expertise and resources necessary to continue development and application of these powerful new technologies. Objectives and Scope The specific purpose of this RFA is to support research projects focused on identification of patterns of molecular alterations in tumors that will become the foundation of molecular-based tumor classification schemes. Multi- disciplinary groups will be funded to focus on the application of comprehensive molecular technologies to the analysis of tumor specimens. These groups, National Cooperative Tumor Signatures Groups (NCTSGs), will be expected to develop new molecular classification schemes for a selected set of tumors based on patterns of molecular alterations rather than on the classical histopathological criteria currently in use. NCTSG applicants should focus on one technology, or a set of related technologies, for application to tumor specimens. The selected technologies can be for analysis of molecular changes in DNA, RNA or protein. The DNA-based technologies can be targeted to the comprehensive analysis of mutations, to the determination of genome-wide cytogenetic changes or to changes in patterns of DNA modifications such as DNA methylation. Technologies can be targeted to the analysis of patterns of gene expression at the level of mRNA. Protein-based technologies can be used to determine patterns of gene expression, changes in protein composition in subcellular compartments, or changes in post-translational modifications of proteins. The selected technology should be able to generate a comprehensive analysis of each tumor specimen. Development of new molecular classification schemes for tumors will depend on a rational approach to the selection of tumor specimens for analysis. Applicants should include a detailed rationale for selecting the class of tumors they plan to analyze. The design of the study should ensure that statistically significant differences among profiles from subsets of tumors can be identified. For example, an applicant could propose to analyze specimens from node-negative breast cancer patients. There is known biological heterogeneity within this group of patients since approximately 30% of these patients will have recurrences and will die of their disease. It is anticipated that molecular profiles can successfully identify subgroups of these patients. Other examples of groups of cancer patients with known heterogeneity include, but are not limited to, patients with multi-focal, organ-confined prostate cancer, stage C colon cancer or anaplastic astrocytomas. The analysis of the selected tumor specimens should be carried out without further reference to morphology or clinical data. The initial identification of subsets of the tumors should result from analysis of molecular profile data. Established profiles can then be annotated with all of the available clinical data, including histopathological data, to examine whether the subsets defined molecularly are associated with clinical parameters. These data can include tumor stage and grade, demographic data and any clinical data that is available such as response to therapy and disease outcome. An additional benefit of developing molecular profiles of tumors is the potential to aid in identifying the primary tumor sites for tumors of unknown origin at the time of diagnosis. Development of schemes for identifying tumors of unknown origin may require a different scientific approach such as establishing profiles that uniquely identify all tumors from a given organ site. In response to this initiative, investigators may propose to identify unique profiles from a large number of organ sites and then to evaluate the utility of these profiles for identifying the primary site for metastatic tumors. Each applicant should clearly document a strategy for obtaining access to high quality tissue specimens that will be needed to carry out their programs. Applicants should also describe the demographic and clinical data that they anticipate they will collect in order to ensure that the molecular profiles obtained will be as informative as possible. Applicants must specifically describe plans to protect patient confidentiality. During the course of the projects grantees may identify needs for additional tissue specimens. NCI program staff will assist grantees in obtaining access to additional tissue resources by facilitating interactions and collaborations between the NCTSGs and other NCI supported research efforts. Appropriate collaborations could be established between the NCTSGs and the clinical trials groups, SPOREs, NCI supported collaborative research networks, NCI Cancer Centers and other NCI supported specimen resources. Establishing these collaborative interactions will ensure that tumor specimens needed to develop molecular profiles are available. Effective data management and analysis will be critical to the successful development of new tumor classification schemes based on molecular profiles since application of comprehensive analytical technologies generates very large quantities of data. The organization and management of the data and the subsequent analysis of the data will constitute a significant challenge to the successful grantees. The NCTSGs will be expected to develop and apply innovative bioinformatics and statistical tools to the management and analysis of the data. Applicants should describe the informatics approaches they plan to develop and/or use. Applicants should provide a detailed description of the design of the proposed studies and the associated statistical strategies that will be used to identify and compare molecular profiles that may be useful for tumor classification. The application of the comprehensive molecular analysis technologies results in the generation of large, information rich data sets. These data sets will be analyzed by the investigators who generated them in order to address the scientific questions that were initially posed. However, it is likely that only a subset of the data used in the analyses will be included in publications resulting from the research. The complete primary data sets would be extremely valuable resources for other researchers who could use them to test additional hypotheses. In order to maximize the return on the NCI's investment in the application of these technologies, NCI program staff will work with the funded investigators to develop a strategy for public release of the data. Applicants should discuss potential strategies for making these valuable molecular data sets available to the cancer research community. Group Structure and Operations Applicants to this initiative are expected to assemble a team of investigators prior to submitting their application; this team will form the nucleus of their NCTSG. Each research team should include the expertise necessary to meet the goals of the RFA. The necessary expertise is expected to include technology developers and engineers to support continued development and/or adaptation of the selected technologies; basic cancer researchers; oncologists and/or pathologists to provide the cancer expertise that will ensure the selection of appropriate specimens for analysis; and statisticians and experts in bioinformatics to provide the appropriate expertise in data management and analysis. It is anticipated that in some cases collaborations between investigators from academic, government and commercial organizations may be necessary in order to include all of the expertise required for the project. This will be particularly true if the technology selected is provided by a commercial organization and the cancer expertise and resources are being provided by an academic institution. In addition, NCI is supporting new and ongoing intramural programs for the comprehensive analysis of molecular alterations in tumors. Where appropriate, applicants are encouraged to take advantage of these resources through collaborations with intramural investigators. Either the academic or commercial organization may take the lead in developing an application and the Principal Investigator may be from either institution. Intramural researchers may not serve as Principal Investigators or Co-Investigators on these applications. The final structure of individual NCTSGs should be consistent with the requirements of the proposed research project. Collaborations among investigators from academic and commercial institutions can be complicated by concerns over issues of intellectual property. The intent of this initiative is to minimize these problems by addressing them at the time the application is submitted. Applicants should provide evidence that these issues are being addressed and that all collaborating institutions recognize that intellectual properties issues should not interfere with research progress. The adequacy of the collaborating institutions' consideration of these issues will be assessed during of review of the applications. It is anticipated that unexpected scientific opportunities may arise during the course of these projects. These opportunities might include breakthroughs in technology development or the appearance of unanticipated novel technologies that could significantly enhance progress toward project goals or breakthroughs in our understanding of cancer which might lead to a shift in research strategy. In order to provide flexibility that will enable the NCTSGs to respond to these new scientific opportunities as they arise, applicants may request developmental funds in their budget for the second through the fifth years of support. These funds will be restricted, and their use will have to be requested and justified by the PI on a yearly basis. Use of these funds will require approval by NCI program staff. These funds may also be used to offset unexpected administrative costs associated with obtaining the clinical specimens. SPECIAL REQUIREMENTS In order to ensure maximum progress in the projects funded by this initiative and to realize the maximum benefit for the cancer research community and ultimately for the ongoing battle against cancer, several special activities will be required of the funded investigators. An annual meeting of all funded investigators will be held to share progress and research insights that may benefit all of the projects. Applicants should request travel funds in their budgets for critical personnel to attend this annual meeting. The annual meeting will be initiated after the first year of funding. As discussed earlier, grantees will be required to develop a plan for the timely release of data to the cancer research community. Applicants should also request travel funds to attend two meetings per year of the planning group. This group will evolve into an implementation and oversight committee as the projects mature. Finally, applicants should state in their applications their commitment to participating in these intergroup activities and their commitment to the public release of data. Terms and Conditions of Award 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 92, and other HHS, PHS, and NIH Grant Administration policy statements. [Part 92 applies when state and local governments are eligible to apply as a "domestic organization."] The administrative and funding instrument used for this program is a cooperative agreement [(U01)/(U19)], 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 will be carried out as a collaboration among the awardees with coordination and facilitation by NCI Program Staff. 1. Awardee Rights and Responsibilities Awardees will have primary responsibility for the project as a whole, including research design and conduct, data collection, data quality control, data analysis and interpretation and preparation of publications, as well as collaborations with other awardees. An NCI Program Staff member will coordinate and facilitate interactions and collaborations among the awardees (see section 3 below). Awardees will retain primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. However, awardees must commit to the release of the data to the cancer research community through a mechanism to be planned and implemented by the awardees and the NCI. It is anticipated that the release of data will occur after the individual investigators have had a reasonable period of time to evaluate their results and realize the appropriate benefits of their own research efforts. Awardees must also commit to sharing research results at the annual meeting of investigators. 2. NCI Staff Responsibilities Program staff will work closely with individual investigators to facilitate collaborations with other NCI-funded research groups to ensure that all investigators have access to the tumor specimens and other resources that may be necessary to successfully achieve their research goals. The NCI program directors responsible for the individual awards will assist in the coordination of activities that involve all of the awardees such as the annual meetings, but only a single NCI program staff member, as described below, will be a member of the Data Release Planning and Oversight Committee. 3. Collaborative Responsibilities Program staff will participate in and facilitate the development of the strategy for making research data widely available to the cancer research community. The Data Release Planning and Oversight Committee, composed of the PI of each NCTSG, a second member from each NCTSG selected by the PI and one NCI Program Staff member, will be responsible for developing a plan for making the data from the comprehensive analysis publicly available in a format that will facilitate use of the data by the cancer research community. The Committee will continue to monitor the implementation of the data release plan for the life of the awards. A chairperson for the Committee will be selected by the participants. The NCI Program Staff member will be a voting member of the Committee but cannot serve as chair and will coordinate and facilitate the work of the Committee. 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 composed of three members -- one selected by the Data Release Planning 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 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. 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. All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators may also obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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 LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by March 23, 1999 or October 5, 1999. The letter of intent should include 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 to avoid conflict of interest in the review. The letter of Intent is to be sent to the program staff listed under INQUIRES. 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 301/435-0714, E-mail: email@example.com. For those applicants with internet access, the 398 kit may be found at http://grants.nih.gov/grants/forms.htm In addition to the PHS 398, applicants submitting U19 applications are to use the NCI program project grant (P01) guidelines (available from the NCI Referral Officer listed under INQUIRIES or at http://deainfo.nci.nih.gov/awards/P01.PDF), in the preparation of applications. 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. 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. 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 also be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636, MSC-7399 Bethesda, MD 20892-7399 Rockville, MD 20850 (for express/courier service) Applications must be received by April 26, 1999 or November 16, 1999. 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 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 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 NCI in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications 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 Applicants are encouraged to submit a research plan describing their own ideas about how best to meet the goals of the RFA. Applicants are expected to address issues identified in the section on SPECIAL REQUIREMENTS of the RFA. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a 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 this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Approach: Are the conceptual framework, design, method, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 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 researchers (if any)? Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Additional review criteria specific for this initiative include: -- access to appropriate tissue resources with the associated clinical data necessary to perform the research; -- demonstrated willingness to collaborate with other funded investigators and with NCI Program Staff in the development of a plan for the release of data and a stated commitment to the timely release of data; -- evidence that the intellectual properties issues are being addressed by the collaborating institutions and will not interfere with productive collaboration; -- appropriateness of the proposed budget and duration in relation to the proposed research. The initial review group will also examine: the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion; the provisions for the protection of human and animal subjects; and the safety of the research environment. For U19 applications, all of the above criteria apply, as well as the review considerations outlined in the NCI program project guidelines (available from the NCI Referral Officer listed above or at http://deainfo.nci.nih.gov/awards/P01.PDF.) In applications for U19 support, interrelationships between component projects are expected to result in greater contribution to the program goals than if each project were pursued separately. AWARD CRITERIA The following criteria will be considered in making funding decisions: the quality of the proposed projects as determined by peer review; the responsiveness of the proposed project to the goals of the RFA; and the availability of funds. SCHEDULE Letter of Intent Receipt Dates: March 23, 1999 October 5, 1999 Application Receipt Dates: April 26, 1999 November 16, 1999 Review by Advisory Board (NCAB): September 1999 May 2000 Earliest Anticipated Start Date: September 30, 1999 July 1, 2000 INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: James W. Jacobson, Ph.D. Division of Cancer Treatment and Diagnosis National Cancer Institute 6130 Executive Boulevard, Room 700, MSC 7388 Bethesda, MD 20892-7388 Telephone: (301) 402-4185 FAX: (301) 402-7819 Email: firstname.lastname@example.org Direct inquiries regarding review issues to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636, MSC-7399 Bethesda, MD 20892-7399 Rockville, MD 20850 (for express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: email@example.com Direct inquiries regarding fiscal matters to: E.C. Melvin Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 258 FAX: (301) 496-8601 Email: firstname.lastname@example.org AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.394, Cancer Detection and Diagnosis Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Parts 52 and 45 CFR Part 74 [and Part 92 when applicable for State and Local governments]. 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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