COOPERATIVE PROSTATE CANCER TISSUE RESOURCE Release Date: April 29, 1999 RFA: CA-99-012 P.T. National Cancer Institute Letter of Intent Receipt Date: July 29, 1999 Application Receipt Date: August 27, 1999 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 from organizations (individual institutions or consortia) capable and interested in working together to create a virtual resource to be known as the NCI Cooperative Prostate Cancer Tissue Resource (hereinafter called "Resource"). A virtual resource is comprised of the specimen archives, which remain at the institution where they were collected, and data associated with the specimens that is maintained in a central database. The Resource will make tissue specimens, with associated demographic, clinical and outcome data, available to support prostate cancer research. Participants will identify critical data elements, design the Resource database, and enter data related to the selected cases. The quality of the specimens and data will be ascertained, a website designed, and a marketing plan developed. Prospective collection of frozen tissue specimens will begin in the second year, both to meet current needs and to create a bank to meet future needs. Demographic, clinical and pathology data related to banked frozen specimens will be collected and entered into the database. Follow-up and outcome data will be added to the database as it becomes available. 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), Cooperative Prostate Cancer Tissue Resource, 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 "Healthy People 2000" (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, Canadian or 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. Applications from minority and women investigators are encouraged. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a 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 role is to support and/or stimulate the recipient's activity by involvement in the project and otherwise working jointly with the award recipient as a partner, but not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the resource 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 1, 2000. This RFA is a one-time solicitation. However, if it is determined that there is a sufficient continuing program need, the NCI will invite recipients of awards under this RFA to submit competitive continuation cooperative agreement applications for review according to the procedures described in this RFA. FUNDS AVAILABLE The NCI intends to commit approximately $1,500,000 in FY 2000 to fund 3 to 5 new awards in response to this RFA. Since the collection and distribution of fresh/frozen specimens will not be initiated until year two, the anticipated budget will increase to $2,400,000/year for years 2-5. An applicant may request a project period of up to 5 years. Because the nature and scope of the expected resources may vary, it is anticipated that the size of each award will also vary. 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 applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES Background Prostate cancer is the second leading cause of cancer death in men. There were about 185,000 new cases of prostate cancer in the United States in 1998 and about 39,000 men died of the disease. The incidence of prostate cancer has risen significantly in the past 25 years. At present, there is an inadequate infrastructure for prostate cancer tissue acquisition, storage, and research use. Existing tissue repositories are few in number and not closely linked to appropriate clinical and pathological information. Further, most existing resources support local research efforts. A national prostate repository will greatly facilitate prostate cancer research efforts nationwide by providing large numbers of specimens with associated clinical data, with quality control of both specimens and data. Initially an archival resource containing paraffin embedded tissues and associated clinical and outcome data will be created. Archival prostate cancer tissues accrued to a national repository could meet the needs of many researchers. Tissue blocks will remain in each of the participating institutions. Necessary patient information should be collected and compiled in such a way as to ensure patient confidentiality. A prospective collection of fresh-frozen tissue will be required to meet anticipated future needs such as the development and application of new technologies to measure RNA, DNA and protein. Applicants will be asked to include plans to bank frozen prostate tumors (malignant, pre-malignant and benign), and normal tissue when available, and to collect associated clinical and outcome data. Procurement of fresh specimens and banking of fresh-frozen tissue will begin in year 2. The availability of institutions with access to large numbers of paraffin embedded specimens and to the associated clinical data should permit the rapid creation of a resource of archival formalin-fixed, paraffin-embedded specimens. The high rate of accrual of new cases of prostate cancer in some institutions should also allow procurement and banking for studies on fresh or frozen prostate specimens. Objectives and Scope This RFA requests applications for the development of a prostate cancer tissue resource that will accrue large numbers (thousands) of prostate cancer cases with archival tissue blocks representative of the patient diagnosis, as well as nodal metastatic tissue blocks, and normal tissue when available (such as prostate tissue adjacent to tumors, or blood cells), as well as the clinical information related to those cases. A network of cooperating institutions will be assembled by the NCI and will work together to meet the goals of the RFA. The PI's and perhaps other participants from the cooperating institutions, and an NCI representative, will constitute a Coordinating Committee to govern the Resource. The Resource will make tissues and associated clinical information available to researchers. An outside scientific review group, the Research Evaluation Panel (REP) will be assembled by NCI in consultation with the Coordinating Committee to review requests for use of the Resource (see "Coordinating Committee" and "Research Evaluation Panel" under TERMS OF COOPERATION). Applicants must propose the establishment of a paraffin tissue archive. Because the number of specimens, the availability of specimens for distribution, the types of specimens, and the quality of accompanying data (demographics, clinical history, treatment, outcome) are important to the utility of the Resource, applicants should estimate their potential to contribute to each of these Resource elements. The first year will focus on creating the bank infrastructure; including forming a coordinating committee to oversee the operation of the bank, developing operating policies and procedures, and identifying cases with appropriate formalin-fixed, paraffin-embedded tissue blocks for entry into the bank. SPECIAL REQUIREMENTS Terms and Conditions of Award 1. 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."] 2. The administrative and funding instrument used for this program is a 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 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. 3. Terms of Cooperation The cooperative agreements (U01) will require cooperation between an NCI representative (the Program Coordinator) and the principal investigators (PI) of the individual projects participating in a Coordinating Committee in order to administer the Resource and ensure smooth interactions among the cooperating organizations. The Program Coordinator participates as a member of the Coordinating Committee and assists in coordinating the activities of the awardees and facilitating communications. The principal investigators, and in some cases other representatives of the cooperating institutions, participate as members of the Coordinating Committee. The Chair of the Coordinating Committee is responsible for maintaining oversight and cooperation among participants and chairing Coordinating Committee meetings. These responsibilities are described more fully below. a. Nature of Participation by NCI Staff The Program Coordinator will be designated by the Associate Director of the Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis. The Program Coordinator's role, as detailed throughout these terms of cooperation is to coordinate, assist and facilitate, but not to direct the activities of the Resource. The Program Coordinator attends and participates as a voting member in all meetings of the Coordinating Committee and will facilitate access to an NCI contractor to assist in implementing the central database for the resource.Data will be supplied to the contractor in a format agreed upon by the Coordinating Committee. The format could include such approaches as a "flat file" or a particular commercial database structure. Ownership of the data is retained by the awardee institutions. The contractor will provide a central point of contact for the resource and to provide support for the implementation and operation of the database. The Program Coordinator also acts as a resource for information about NCI activities. As a member of the Coordinating Committee, the Program Coordinator attends and participates in all Coordinating Committee meetings and assists in developing operating policies and procedures and assures that those policies are acceptable to the NCI. The NCI Program Coordinator may review the activities of awardees for compliance with operating policies developed by the Coordinating Committee and may recommend withholding support, suspension or termination of an award for failure to comply with such policies. An arbitration system, detailed below, is available to resolve disagreements between awardees and NCI staff. b. Responsibilities of Awardees The PI in cooperation with the other Coordinating Committee members is responsible for developing the details of Resource operating policies, including defining objectives and approaches, planning, implementation and interaction with other Resource awardees, marketing the Resource, managing fiscal arrangements regarding charges for the distribution of Resource specimens, and establishing quality assurance measures for all aspects of the operation of the Resource. The PI must also assure that designated Resource tissues remain available and that the relevant clinical data, as designated by the Coordinating Committee, is obtainable. The PI can be required, at the discretion of the Chair, to submit a progress report at any meeting of the Coordinating Committee. Awardees retain custody and primary rights to data developed under these awards, subject to government (e.g., NCI, NIH or PHS) rights of access, consistent with current DHHS, PHS and NIH policies. c. Coordinating Committee The NCI and awardees are responsible for forming a Coordinating Committee to oversee the operation of the Resource. The Coordinating Committee will act as the governing body of the Resource and all participants are bound by its actions. The structure of the Coordinating Committee will be defined at the first meeting. Initially the Coordinating Committee will consist of the principal investigator for each cooperating institution and the Program Coordinator. Additional members may be added at the first or subsequent meetings by action of the Coordinating Committee. The Coordinating Committee will meet three times in the first year and at least twice a year with additional meetings and conference calls as necessary. Meetings may be held at any of the participating organizations or at another convenient location. These meetings are aimed at coordinating the activities of the participating laboratories, establishing new policies and priorities, and reviewing progress. At its initial meeting, the Coordinating Committee will elect a chairperson (who cannot be the Program Coordinator). The Chair is responsible for coordinating the Committee activities, for preparing meeting agendas, and for scheduling and chairing meetings. The Coordinating Committee is initially responsible for reviewing and implementing, as appropriate, the plans for the Resource proposed in the individual applications. It is responsible for developing uniform procedures to accession, process, and distribute tissue, uniform quality control methods and rules for access to the clinical and outcome data associated with the accrued cases. It will also review and approve the local operating procedures proposed by each awardee to insure that they are compatible with the overall goals of the RFA. d. Research Evaluation Panel (REP) The Research Evaluation Panel (REP) is an independent group of experts that will be constituted by the NCI in consultation with the Coordinating Committee. The REP is responsible for reviewing requests from investigators for tissues. The REP then provides scientific advice about the scientific quality and priority of the request to the NCI and the Coordinating Committee. An NCI representative to the REP, the Program Liaison, will be designated by the Associate Director of the Cancer Diagnosis Program. The Program Liaison, who cannot be the NCI Program Coordinator nor chair the REP, is a member of the REP and participates in developing recommendations to the Coordinating Committee about the scientific importance of proposed assays and the design of proposed studies. The REP works independently but collaboratively with the Coordinating Committee. The composition and expertise of the REP will be determined initially by the Coordinating Committee. REP members must have appropriate expertise in prostate cancer and might include clinicians, laboratory researchers, statisticians or members with other expertise that the Coordinating Committee determines to be needed. Two members of the Coordinating Committee serve as ad hoc non-voting members of the REP. Once the REP is established, the REP will select replacements for members who have completed their terms. Operating policies for the REP will be determined by the REP, consistent with operating policies developed by the Coordinating Committee. The REP members will attend at least one Coordinating Committee meeting each year to help coordinate REP activities with those of the Coordinating Committee. This meeting may be associated with a REP meeting as required. 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 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 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. Applications received in response to this RFA are expected to focus on scientific issues related to prostate cancer. In describing the plan to recruit human subjects, investigators may cite a focus on prostate cancer as the justification for why women will be excluded. In this regard applicants may use Justification 1 from the policy announcement: the research topic to be studied is irrelevant to women. 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://www.nih.gov/grants/guide/notice-files/not98-024.html As part of the scientific and technical merit evaluation of the research plan, reviewers will be instructed to address the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion. Applications received in response to this RFA are expected to focus on scientific issues related to prostate cancer. In describing the plan to recruit human subjects, investigators may cite a focus on prostate cancer as the justification for why children will be excluded. In this regard applicants may use Justification 1 from the policy announcement: the research topic to be studied is irrelevant to children. LETTER OF INTENT Prospective applicants are asked to submit, by July 29, 1999, 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, other participating institutions if any, and number and title of the RFA. 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 INQUIRIES. APPLICATION PROCEDURES Awards will be made to multiple institutions or consortia to create a multi- institutional virtual resource with a central database. The special requirements listed below address the ability of applicants to contribute tissues and data to the Resource and the ability and to cooperate with Principle Investigators from several other institutions, whose identity not be known until after the award. 1. Applicants should describe the available institutional resources. a. Estimate the anticipated number of cases that have available archival blocks and complete clinical and outcome data. Applicants should describe the racial, ethnic and age distribution of their cases. In addition, describe the types of specimens (biopsy or prostatectomy, benign tissue, normal tissue, etc.) that are available. Applicants should also estimate their access to cases with fresh prostate specimens suitable for freezing and the numbers and types of specimens that will be available. b. Describe how Gleason grading is performed. Is a Gleason score rendered on each prostate cancer specimen at diagnosis? If so, describe the Gleason components recorded. Are prostate cases coded or indexed by a standard nomenclature (e.g. SNOMED)? 2. Applicants should propose detailed plans for organizing the Prostate Cancer Tissue Resource a. Applicants should propose plans to develop an archival prostate cancer tissue resource. Describe methods to accrue cases, as well as procedures for identifying and retrieving tissue blocks. Include operating procedures for handling specimens, including quality control, inventory management, specimen preparation, shipping, etc. Propose appropriate procedures and methods for obtaining and validating the demographic, clinical and outcome data, including quality control associated with cases, information and ideas for implementing the database including common data elements and formats for data transmission to the central database. b. Propose plans to develop a prostate tissue procurement service and a prospective frozen tissue bank designed to include the same data as the archival bank and describe the logistical measures required to procure and distribute specimens. The budget for year two should include any additional staff needed for tissue procurement. The budget should also list and justify any additional equipment (liquid Nitrogen freezers, etc) needed to bank tissue. Applicants should clearly detail their ability to contribute to the procurement and banking efforts, including agreements with relevant practitioners. c. Propose methods for marketing the Resource to the scientific community and include the costs of these efforts as budget items. 3. Applicants are encouraged, but not required, to include plans for developing and contributing to an electronic image library of prostate tissues. A large archive of imaged biopsies linked to clinical data could permit rapid access to morphologic information for case selection and rapid verification of diagnosis, thus reducing the time for histology review. 4. Since the Terms of Cooperation will be included as terms of award in all awards issued as a result of this RFA, applicants should specify their willingness to participate in all activities described in "Terms and Conditions of Award," and applicants should specify their willingness to interact with the Coordinating Committee and be bound by the actions of the Coordinating Committee. They should also propose what expertise is needed in order to create an effective REP. 5. 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 procedures to obtain informed consent for prospective procurement of tissues and patient data. 6. 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. Travel to national meetings to take part in exhibits to market the Resource should also be included as a budget item. 7. Since the REP will meet with the Coordinating Committee once a year, funds to support travel by one member of the REP to attend one Coordinating Committee meeting each year should also be included in each budget. Submission Instructions 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: firstname.lastname@example.org. For those applicants with Internet access, the 398 kit may be found at http://www.nih.gov/grants/funding/phs398/forms_toc.html 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 August 27, 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 for 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 The goal of NIH-supported human specimen 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 resource 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 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. (1) Significance: Does the resource design fulfill the needs of the cancer research community? Will the resource facilitate progress in the field of prostate cancer research? (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 consider alternative tactics? (3) Innovation: Does the project employ creative approaches and methods for the development and implementation of the resource? (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 participants? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed resource 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: Quality and quantity of the pre-existing surgical pathology and prostate tissue archives serving the applicant institutions Quality of the pre-existing hospital or laboratory information services of the applicant institutions. This would include the completeness, quality, extensiveness, quantity and accessibility of clinical and pathological information pertaining to patients who have had prostate biopsies in the applicant institutions. It is desirable that the data be stored in electronic form. 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: July 29, 1999 Application Receipt Date: August 27, 1999 Review by NCAB Advisory Board: February 15, 2000 Earliest Anticipated Start Date: April 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: Jules J. Berman, Ph.D., M.D. Resources Development Branch, Cancer Diagnosis Program National Cancer Institute 6130 Executive Boulevard, Room 700, MSC-7420 Bethesda MD 20892-7240 Rockville, MD 20850 (for express/courier service) Telephone: (301) 496-7147 FAX: (301) 402-7819 Email: email@example.com 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: firstname.lastname@example.org Direct inquiries regarding fiscal matters to: Ms. Sara Stone Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243, MSC 7150 Bethesda, MD 20892-7150 Rockville, MD 20850 (for express/courier service) Telephone: (301) 496-7800 ext. 266 FAX: (301) 496-8601 Email: email@example.com AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.3 94 Cancer Detection and Diagnosis. Awards are made under authorization of the sections 301 and 405 of the Public Health Service Act, as amended (42 USC 241 and 284) 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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