COOPERATIVE HUMAN TISSUE NETWORK Release Date: March 23, 2000 RFA: CA-01-009 (Reissued as RFA-CA-08-503) National Cancer Institute Letter of Intent Receipt Date: July 13, 2000 Application Receipt Date: August 17, 2000 PURPOSE The Cancer Diagnosis Program of the National Cancer Institute invites applications for Cooperative Agreements from institutions capable of and interested in participating in the Cooperative Human Tissue Network (CHTN). The purpose of this existing national network is to collect and distribute benign, pre-cancerous and cancerous human tissue specimens for basic and developmental studies in cancer research. The network was established to facilitate research by providing human tissue specimens to the general scientific community. Since its establishment in 1987, the CHTN has provided more than 200,000 high quality specimens from a wide variety of organ sites to over a thousand investigators. Basic and developmental studies in numerous areas of cancer research have been facilitated by the availability of these specimens. The objective of this Request for Applications (RFA) is to continue and expand the network to ensure that specimens critical to progress in cancer research are available to the scientific community. 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, Cooperative Human Tissue 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 domestic for-profit and non-profit organizations as well as those in Canada and Mexico, public and private, such as universities, colleges, hospitals, laboratories, units of State and Local governments, and eligible agencies of the Federal Government. Applications with components involving countries other than Canada and Mexico may not be submitted. 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 a cooperative agreement (U01) in which substantial NIH scientific and/or programmatic involvement with the awardee during performance of the activity is anticipated. The Principal Investigator defines the details of the project within the guidelines of the RFA, retains primary responsibility for the performance of the activity and agrees to accept the cooperation and assistance of NCI staff (through the NCI Program official) in the scientific and technical management of the project. Details of the responsibilities, relationships and governance of the project 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, 2001. This RFA is a one-time solicitation. If it is determined that there is a sufficient continuing program need, the NCI may re-compete this initiative through the cooperative agreement or other appropriate mechanism. FUNDS AVAILABLE The NCI intends to commit approximately $4 Million dollars in FY 2001 to fund 5 to 7 new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 5 years. Because the nature and scope of the project proposed may vary, it is anticipated that the size of individual awards 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 meritorious applications. RESEARCH OBJECTIVES Background The Cooperative Human Tissue Network (CHTN) (http://www-chtn.ims.nci.nih.gov) was established by the NCI in 1987 to address the increasing demand by the scientific community for access to high quality human tissue specimens for cancer research. Often researchers are unable to establish the necessary clinical collaborations for access to the specimens they need. This cooperative network of tissue collection laboratories was established to make high quality human specimens available to the general scientific community for basic and developmental cancer research. The CHTN currently consists of a network of five institutions that collect specimens prospectively to meet researchers= requests. Normal, benign, pre-cancerous and cancerous human tissue with associated histopathologic and demographic data is provided to researchers throughout North America. The CHTN is not a tissue bank, but does store limited numbers of specialized tumor types, such as rare pediatric tumors, to ensure their availability. Four Divisions of the CHTN are each assigned a geographic area of the United States from which requests for researchers are received. A fifth Division, the Pediatric Division, provides rare pediatric tumor specimens nationwide. In order to serve investigators as rapidly as possible, specimen requests that cannot be filled within a few weeks by the assigned Division are "networked" to all Divisions. The existing network has demonstrated the feasibility of the network approach for responding to requests for specimens. Systems have been developed to facilitate efficient communication among laboratories and to share tissue requests and determine specimen availability. Since its creation in 1987, the CHTN has become a vital resource for the cancer research community. The CHTN has continued to grow, providing more than 50,000 specimens in 1999. Efforts to define the molecular signatures of cancer cells and the continued emphasis on the application of molecular and other emerging technologies to human specimens is expected to significantly increase the demand for specimens. Services, such as tissue microarrays, microdissection services, and RNA/DNA preparations, may also be needed. This RFA requests applications to continue and expand the network in order to ensure that the necessary resources are available to the scientific community. The Network is expected to facilitate basic discovery in cancer research as well as the development and application of new technologies to clinical specimens. Objectives and Scope: This RFA requests applications for cooperative agreements from organizations (individual institutions or consortia) capable of and interested in participating in the Cooperative Human Tissue Network. The major focus of this cooperative tissue collection and distribution network will be to continue and improve access to high quality human tumor tissue with associated histopathologic and demographic data. The NCI will fund 5 - 7 institutions to work together as a network to prospectively collect and distribute high quality tissue specimens to investigators throughout North America. The Network will provide large numbers of tumor specimens from a wide variety of cancers and provide researchers with access to specimens of rare tumor types. Normal, malignant and benign human tissue will be collected and prepared to meet researcher requests. Specimens will be excess materials collected during the course of routine medical care or at autopsy. The Network will not function as a tumor bank, but may store specimens pending the completion of shipments and may bank rare tumors that would not otherwise be available. Pre-malignant lesions, when available, can also be stored for future distribution to facilitate early detection research. The Network is intended to provide specimens for basic and developmental studies. Therefore, data routinely provided with the specimens will generally be limited to histopathologic and demographic information such as diagnosis, sex, age and race. Members of the Network will be expected to collaboratively establish and implement appropriate procedures to collect, process and handle specimens to assure that they are of the highest quality and suitable for a wide variety of studies and technologies. In order to ensure the availability of suitable specimens for patient diagnosis and quality control of research specimens, the Principal Investigator of each participating group must be an experienced surgical or anatomical pathologist, actively involved in the operation of a pathology laboratory that has demonstrated access to human cancer tissues. Applicant institutions with the necessary expertise may propose to provide additional services such as RNA/ DNA preparations, tissue microarrays, and/or laser capture microdissection, these services should be carefully described and justified. Although separate awards will be made to a number of institutions, awardees will be required to work collaboratively with other Network members. Requests for specimens will be shared by network participants so that requests can be filled more rapidly. Existing software developed by the current network will be made available to allow all members of the network to share requests for specimens via a computer network linking the participating organizations. General operating policies for the Network will be established by a Coordinating Committee that will consist of the Principal Investigators, a second representative from each participating institution and a representative from the NCI. The Coordinating Committee will establish standards for quality control, define equitable policies for distributing specimens, set processing and handling fees, develop biohazard procedures and establish policies to address the legal, ethical, and human subjects issues related to the use of human specimens for research. Awardees must agree to provide specimens to the scientific community without any requirement for collaboration. The costs of processing and handling, shipping and other appropriate costs may be charged to researchers, in accordance with policies established by the Coordinating Committee. The Network is expected to remain responsive to changes in the science. The Coordinating Committee will establish mechanisms to assess the changing specimen needs of the scientific community and make operational changes or modifications of CHTN services as needed to rapidly respond to those needs. The Network must meet the requirements of the federal human subjects regulations 45CFR46, (the Common Rule, https://grants.nih.gov/grants/oprr/humansubjects/45cfr46.htm). Federal requirements to protect human subjects apply to a much broader range of research than many investigators realize, including research that uses human specimens (such as cells, blood, and urine), residual diagnostic specimens and medical information. The NIH has developed a brochure entitled, "Research on Human Specimens: Are You Conducting Research Using Human Subjects?" to help investigators understand how the human subjects regulations apply to the research use of human specimens. This brochure can be downloaded from http://www-cdp.ims.nci.nih.gov/policy.html or obtained from the program contact listed under INQUIRIES below. The Network is expected to address the evolving legal, ethical and human subjects policy issues related to the use of human specimens for research purposes. These issues have been the subject of considerable discussion in a variety of settings (see The National Bioethics Advisory Commission report entitled Research Involving Human Biological Materials: Ethical Issues and Policy Guidance http://www.georgetown.edu/research/nrcbl/nbac/pubs.html). A consensus emerging from these discussions is that informed consent beyond that provided in the surgical consent form is desirable for research use of identifiable specimens collected during routine medical care. To address this issue, the Network will be expected to develop and implement improved approaches to obtain consent for future research use of tissue. Applications submitted in response to this RFA must include plans to obtain consent for future research use of specimens collected on this project or to sever any link between the specimen to be distributed to the researcher and the identity of the patient. SPECIAL REQUIREMENTS The Principal Investigator of each application must be an experienced surgical or anatomical pathologist, actively involved in the operation of a pathology laboratory with demonstrated access to human cancer specimens. Terms and Conditions of Award The cooperative agreements awarded under this RFA will require cooperation between an NCI representative (the Program Coordinator) and the principal investigators (PI) to administer the Network and assure smooth interactions among the cooperating institutions. The Program Coordinator participates as a member of the Coordinating Committee and assists in advising the awardees and facilitating communications. These responsibilities are described more fully below. a. Awardee Rights and Responsibilities The principal investigator (PI) of a Cooperative Human Tissue Network award should be an experienced surgical or anatomic pathologist with demonstrated access to a wide range of human cancer tissues. The PI retains primary responsibility for the performance of activities supported by each award. Two members of each awarded research group are required to serve as members of the CHTN Coordinating Committee (as stipulated below) to help formulate and implement CHTN operating policies. Awardees are required to have access to appropriate cancerous and normal human tissue specimens and to make them available to the research community according to the policies established by the CHTN Coordinating Committee. Awardees must agree to implement procedures to obtain consent for future research use of specimens or to sever the link between the specimens to be distributed to researchers and patient identities according to the policies and time frames established by the Coordinating Committee. Each awardee is required to submit reports summarizing their individual activities to the Coordinating Committee, according to the formats, frequencies and time frames established by the 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. b. NCI Staff Responsibilities 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 advise, assist and facilitate, but not to direct the activities of the Network. The Program Coordinator will attend and participate as a voting member in all meetings of the Coordinating Committee, and provide liaison between the Coordinating Committee and the participating groups. The Program Coordinator will assist the Coordinating Committee in developing operating policies and procedures and assure that those policies are acceptable to the NCI. The Program Coordinator may review the operations of individual laboratories for compliance with quality control standards and with operating policies developed by the Coordinating Committee. The Program Coordinator may recommend withholding of support, suspension or termination of an award for failure to adhere to policies established by the Coordinating Committee. The Program Coordinator monitors the operation of the Network and may request the Coordinating Committee to consider modification of operating policies as required to maintain quality control or to serve new research needs of the scientific community. The Program Coordinator will also serve as the NCI Program Director for the normal stewardship responsibilities of the project. An arbitration process, detailed below, is available to resolve disagreements between awardees and NCI staff. c. Collaborative Responsibilities A Coordinating Committee will be established to oversee the operation of the network. The Coordinating Committee will act as the governing body of the CHTN and all participants will be bound by its actions. The Coordinating Committee develops Network operating policies, which must be implemented by the PIs at each cooperating site. The Coordinating Committee reviews the operating procedures of the participating sites to ensure that they are compatible with the overall goals and policies of the Network, the NCI and the NIH. The Coordinating Committee will a) establish uniform standards and policies for tissue acquisition, processing, distribution and storage, b) develop uniform methods of histopathological diagnosis, and assure appropriate control of tissue quality, c) establish strategies to market the resource, d) develop policies for addressing the legal, ethical and human subjects issues related to the use of human specimens for research and establish biohazard procedures, e) develop guidelines and standards for informatics and data management required for operation of the Network, and f) establish procedures for effective communication, and g) develop other network policies as needed. The Coordinating Committee will meet initially to plan for integration of any new cooperating institutions and/or phaseout of current institutions and to review and acccept or modify currently established operating procedures and policies. The Coordinating Committee will meet at least twice a year. The Coordinating Committee may establish subcommittees of the CHTN as necessary. d. Arbitration Disagreements between award recipients and the NCI with regard to scientific/programmatic matters (within the scope of the award) or implementation of proposed operating policies may be brought to arbitration. An arbitration panel will be formed consisting of one member selected by the Coordinating Committee, one member selected by the NCI, and a third member chosen by the other two members of the arbitration panel. The NCI arbitration process for the Network in no way affects the rights of awardees to appeal selected postaward administrative decisions in accordance with PHS regulations at 42 CFR part 50, subpart D and HHS regulations 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 subpopulations 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, available on the web at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not94-100.html Investigators may also obtain copies of the policy from the program staff listed under INQUIRIES. 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: https://grants.nih.gov/grants/guide/notice-files/not98-024.html URLS IN NIH GRANTS 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 July 13, 2000, a letter of intent that includes a descriptive title of the proposed project, 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 and plan the review. The Letter of Intent is to be sent to Ms. Marianna J. Bledsoe at the address 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. Application 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 https://grants.nih.gov/grants/forms.htm A number of specific points related to this RFA must be addressed in the application. 1. Applicants should describe their ideas for how the network as a whole might operate and how their site will integrate with the other network sites. Applicants should describe how the proposed plans will address the needs of the scientific community and facilitate research progress. 2. Applicants should describe the services they can provide and how those services will address the needs of the scientific community. Describe access to human specimens for cancer research, including the number and types of specimens with associated histopathologic and demographic data that could be made available. 3. Describe in detail the procedures for collecting, processing and distributing specimens. In particular: a) document the quality control procedures in place at each collecting site, b) propose a system to prioritize access to specimens, c) describe how requests for specimens will be received and shared with other network participants, and d) describe existing or proposed information systems to manage the resource and how they would facilitate the operation of the network. 4. Applicants should propose methods for marketing the resource to the scientific community and include appropriate costs in the budget. 5. In the Research plans section, applicants must address their willingness to accept the Terms and Conditions of Award. a) Applicants should clearly address their willingness to collaborate with the other awardees and to serve on the Coordinating Committee and to be bound by its decisions. b) Applicants should also address the involvement of the NCI representative and how they will fulfill their responsibility to work together cooperatively with other network participants. c) Applicants should describe the strengths they would bring to collaborative network activities such as establishing CHTN policies and priorities, assuring quality of network services, marketing the resource, developing information systems to manage the resource, monitoring progress, and developing strategies to ensure that the resource remains responsive to researchers= needs. 6) The background, qualifications, and experience of the PIs and other key personnel in the collection, processing, quality control and distribution of specimens for research should be well described. 7) Applicants must complete the "Human Subjects" section of the PHS 398. Each application must include a full discussion of the procedures in place for protecting human subjects under 45CFR46 and for protecting patient confidentiality. 8) The application should address the legal, ethical and human subjects policies issues related to the use of specimens for research. It must include a proposal for obtaining consent for future research use of tissue or a plan to sever the link between the specimens to be provided to the researcher and the identities of the patients. 9) Each application must completely describe the representation of gender, minorities, and children in their patient populations. 10) For competing renewal applications, the application should include a discussion of progress made by the individual collaborating group and the specific contributions of the individual collaborating group to the Network as a whole. Collaborative activities among the network participants should be described. Budgetary issues: 1) Travel funds for two people to attend three Coordinating Committee meetings in the first year and two Coordinating meetings per year thereafter should be included as a budget line item. Travel to national meetings to take part in exhibits to market the CHTN should also be included. Travel for other purposes may be proposed with appropriate justification. This includes, but is not limited to, travel for Coordinating Committee subcommittee meetings or other appropriate meeting travel. 2) Budget items may be proposed, with appropriate justification, for expenses to be shared by all network members. These include, but are not limited to, shared costs for administrative activities, database development and maintenance and marketing activities. A detailed budget justification should be provided for each shared budget item requested. 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: https://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 Applications must be received by August 17, 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and 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 Division of Extramural Activities of the National Cancer Institute 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 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 meritorious 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: Will the resource, as proposed by the applicant, help to fulfill the needs of the cancer research community? To what extent will the proposed resource benefit the cancer research community? Will the proposed resource support progress in cancer research? Innovation: Does this resource, as proposed by the applicant, provide access to unique resources or provide services to the general cancer research community which would otherwise not be available? Does this resource propose creative or improved methods, such as more efficient and effective means of collecting high quality specimens, new approaches for obtaining informed consent from human subjects and maintaining confidentiality, more efficient and effective methods of sharing specimen requests, improved information systems to support resources or more effective marketing techniques or strategies to utilize the resource? Approach: Are the conceptual framework, design, methods and analyses of the resource as proposed by the applicant adequately well integrated and appropriate to the goals of the RFA? What is the merit of the proposed plans for the collection and distribution of specimens? Are appropriate plans in place to assure the collection of large numbers of high quality specimens with associated demographic and histopathologic data or rare specimens which would otherwise not be available? What is the merit of the proposed plans for quality control of specimens and/or services? Are the proposed procedures for the protection of human subjects and patient confidentiality appropriate? Are the proposed procedures for the evaluation of requests for specimens and other services reasonable and equitable? Are the plans for cooperation and coordination among participating awardees and the NCI well-described and are they likely to be effective? Investigators: Is the Principal Investigator an experienced anatomic and surgical pathologist with access to specimens? Are the qualifications, experience and proposed responsibilities of the Principal Investigator and key support personnel well suited to organize and maintain the resource, maintain quality control and equitable access, and manage record keeping? Environment: Does the environment contribute to the probability of success? Are the facilities and equipment for the resource adequate? 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? The initial review group will also examine: the appropriateness of proposed project budget and duration, 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. AWARD CRITERIA Applications recommended by the National Cancer Advisory Board will be considered for award based upon (a) scientific and technical merit, (b) program relevance and 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 13, 2000 Application Receipt Date: August 17, 2000 Peer Review Date: October or November 2000 Review by NCAB Advisory Board: February 14, 2001 Earliest Anticipated Start Date: April 1, 2001 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: Marianna Bledsoe, M.A. Division of Cancer Treatment and Diagnosis National Cancer Institute Executive Plaza North, Room 700 6130 Executive Boulevard Bethesda, MD 20892-7399 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-7147 FAX: (301) 402-7819 Email: mb80s@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 Rockville, MD 20852 (express courier) Bethesda MD 20892-8239 Telephone (301) 496-3428 Fax: (301) 402-0275 Email: tf12w@nih.gov Direct inquiries regarding fiscal matters to: Ms. Eileen M. Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-8791 Fax: (301) 496-8601 Email: Natolie@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 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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