QUICK-TRIALS FOR NOVEL CANCER THERAPIES Release Date: January 27, 2000 PA NUMBER: PA-00-047 National Cancer Institute National Center for Complementary and Alternative Medicine Letter of Intent Receipt Date: One month prior to application receipt date Application Receipt Dates: April 9, August 9, December 9 through August 9, 2002 THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA. PURPOSE Continuing advances in molecular genetics and drug development have led to new approaches for inhibiting tumor growth either directly or by impacting the tumor microenvironment. These agents include new classes of cytotoxic agents, agents or approaches that act via immune-stimulatory effects, agents that inhibit angiogenesis and metastasis or alter signaling pathways, and agents targeted specifically to novel cancer cell targets. At present, there is a paucity of funding mechanisms targeted to stimulate the transition of promising and potentially relevant advances in new drug development from the laboratory into the clinical setting for the treatment of early and advanced disease. Similarly, there are limited means to support rigorous evaluations of complementary and alternative medicine (CAM) treatments for cancer, such as botanicals, unconventional pharmacological and biological interventions, or mind-body approaches. The QUICK-TRIAL program was initially published as a pilot program in prostate cancer. This Program Announcement (PA) sponsored by the National Cancer Institute and the National Center for Complementary and Alternative Medicine expands the initiative to all cancer sites and provides investigators with rapid access to support for pilot, phase I, and phase II cancer clinical trials testing new agents and patient monitoring and laboratory studies to ensure the timely development of new therapeutic approaches. QUICK-TRIAL will provide a new approach designed to simplify the grant application process and provide a rapid turnaround from application to funding. Features include a modular grant application and award process, inclusion of the clinical protocol within the grant application, and accelerated peer review with the goal of issuing new awards within five months of application receipt. Inclusion of the complete clinical protocol within the PHS 398 grant application is intended to simplify the application process by eliminating the need to duplicate protocol details in the Research Plan section. Investigators may apply for a maximum of two years of funding support using the exploratory/developmental (R21) grant mechanism for up to $250,000 direct costs per year. This PA supersedes and replaces both PA-99-070, Quick Trials for Prostate Cancer Therapy, published in the NIH Guide for Grants and Contracts, March 5, 1999, and PAR 97-006, Small Grants for Therapeutic Clinical Trials of Malignancies, published in the NIH Guide for Grants and Contracts, Vol. 25, No. 37, November 1, 1996. 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 PA, QUICK-TRIALS for Novel Cancer Therapies, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, 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. Racial/ethnic minority individuals, women, and persons with disabilities as well as new clinical investigators are encouraged to apply as principal investigators. An application may include one or more institutions (e.g., individual institutions, consortia, cancer centers) with established clinical, laboratory, and statistical resources. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) exploratory/developmental grant (R21) mechanism. The exploratory/ developmental (R21) grant mechanism is utilized for pilot projects or feasibility studies to support creative, novel, high risk/high payoff research that may produce innovative advances in science. The exploratory grant program provides support for short-term (up to two years) research projects. Applications submitted in response to this PA will be limited to $250,000 direct costs per year (includes third party facilities and administrative costs). These grants are non-renewable, and continuation of projects developed under this program will be through the traditional unsolicited investigator-initiated research grant program. Applicants will be responsible for the planning, direction, and execution of the proposed project. All PHS and NIH grants policies will apply to applications received and awards made in response to this program announcement. The total project period for applications submitted in response to this PA may not exceed 2 years. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm For this PA, funds must be requested in $25,000 direct cost modules. A feature of the modular grant is that no escalation is provided for future years, and all anticipated expenses for all years of the project must be included within the number of modules being requested. Only limited budget information is required and any budget adjustments made by the Initial Review Group will be in modules of $25,000. RESEARCH OBJECTIVES Background With advances in our understanding of the basic biology of cancer, tumor immunology, and the molecular genetics of cancer, new approaches for inhibiting tumor growth either directly or by impacting the tumor microenvironment have been identified. Novel drug therapeutics based on these new approaches are ready to be tested in the clinic with new tools and laboratory analyses that allow investigators to ascertain how specific targets are affected by therapy. These approaches include new classes of cytotoxic agents, agents acting via immune-stimulatory effects, agents that inhibit angiogenesis and metastasis or alter signaling pathways, and agents targeted specifically to novel cancer cell targets. New clinical therapeutic trials may employ drugs, biologics, radiation, or surgery used as single agents/modalities or in combination for the treatment of early and advanced disease. In addition, clinical trials of CAM therapies for cancer treatment, including, but not limited to, mind-body approaches (e.g., relaxation, imagery, meditation, psychosocial support groups, or psychotherapy, etc. ), herbal therapies, dietary supplements, or unconventional pharmacological and biological interventions (e.g., antineoplastons, Coley’s toxin, enzyme therapies, etc.) will be considered. At present, there are few funding mechanisms targeted to stimulate the communication of promising and potentially relevant advances in new drug development from the laboratory into the clinical setting. Quite frequently the initial stages of clinical investigation are the most difficult to accomplish. They are resource intensive, and to be done well they require laboratory, pharmacology, and other resource support, as well as substantial personnel effort, none of which is supported by health benefit programs. Nonetheless, these early studies tend to fare poorly in competition for conventional grant support precisely because they are preliminary and cannot serve as the definitive tests of new approaches. Even when funding is received, the review and award cycle may introduce a year or more of delay. Except where there is an industrial sponsor with a particular commitment to development of an agent, it may take a long time for a promising approach to get through the initial phase of demonstrating feasibility and interest, or it may never be tested in more than one or two diseases. NCI recently published a new initiative entitled Rapid Access for Intervention Development or RAID (http://dtp.nci.nih.gov) to support the clinical development of new agents by providing access to NCI resources for toxicity studies and formulation and production of new agents for clinical use. The QUICK-TRIAL program will serve as an extension of RAID by providing a new initiative with accelerated peer review and funding to support the clinical and laboratory costs of early clinical testing to ensure the timely development of new therapeutic approaches. Objectives and Scope The aim of this initiative is to support pilot, phase I, and phase II clinical trials and associated patient monitoring and laboratory studies for the treatment of malignancies using novel therapeutic approaches. Therapeutic trials in human subjects employing new agents and therapeutic approaches, including CAM treatments, whether used as a single agent/modality or in combination, are appropriate. Preference will be given to clinical trials that include laboratory studies to validate mechanistic hypotheses or clinical correlates that can meaningfully guide further clinical development. The QUICK-TRIAL program may therefore serve as a extension to the RAID program but may also be used by applicants whose agents have emerged from industry development programs, where support may only be needed for mechanistic and correlative laboratory studies. Applicants to the QUICK-TRIAL program may request support for the conduct of either the clinical trial, the proposed laboratory studies, or both. Whether the studies are focused on the clinical trial or laboratory studies, the grant application package must include the complete clinical protocol in the Human Subjects section of the grant application. Including the protocol as the major part of the QUICK-TRIAL application is intended to save the applicants the significant additional labor of repeating the details of the trial in the body of the grant application. Where support is sought for the actual clinical trial, the protocol should be authored by the investigators applying for QUICK-TRIAL support. In cases where the investigator seeks support only for laboratory studies to accompany a trial funded by a company, a protocol written by the drug sponsor or other clinical investigators is acceptable. Support for the conduct of the clinical trial and/or patient monitoring and correlative laboratory studies that have clinical relevance to the therapeutic clinical trial may be requested. A rigorous description of the rationale and methodology for the laboratory components of the study, as well as a description of how the results will be analyzed in conjunction with the results of the clinical trial, should be provided. Laboratory studies using patient specimens from the clinical trial may include patient monitoring studies (i.e., pharmacokinetics, immune response, etc) or clinical correlative studies that may guide clinical development of the new agent or approach or identify patient subsets for specific therapies. Laboratory studies of the underlying mechanisms of intervention, the mechanisms of disease pathogenesis, or surrogate markers of disease activity and therapeutic effect are encouraged. Statistical design issues should be addressed in the research plan for both the clinical protocol and the laboratory analyses. The proposed research plan should convince reviewers that the planned studies are well conceived, that the methodology is solidly grounded and practical for use in a clinical trials setting, and that the analysis plan is sensible and likely to be informative. In order to review and confer awards to applications received in response to this PA in a timely fashion without delay of the clinical trial, NCI and CSR have developed a pilot project for accelerated review/award. QUICK-TRIAL will provide a new approach designed to simplify the grant application process and provide a rapid turnaround from application to funding. Features include a modular grant application and accelerated peer review with the goal of issuing new awards within five months of application receipt. Investigators may apply for up to two years of funding support. It is expected that patient accrual will be completed within the two year funding period even though final patient outcome analysis may not occur for 1-2 years later. In order to permit rapid turnaround of the grant applications, IRB approval must be obtained prior to review of the grant application. If FDA IND approval is needed, documentation of IND submission must be included in the grant submission. Investigators who intend to use NCI sponsored drugs must submit a Letter of Intent (CTEP LOI) to the Cancer Therapy Evaluation Program, NCI, (http://ctep.info.nih.gov/IDB) prior to grant submission. The CTEP LOI for requesting drugs should mention your plans to submit a grant application for this PA. An approval letter from CTEP confirming potential drug availability must be received prior to grant submission. This is to insure availability of sufficient quantities of drug and to avoid unjustifiable duplication of studies already in progress. Because the QUICK-TRIAL program is designed to support novel and innovative ideas and utilizes the exploratory grant mechanism, preliminary data as evidence of feasibility are not required. However, the applicant does have the responsibility for providing a convincing rationale and justification for the proposed developing a sound research plan. Originality of approach and potential significance of the proposed research are major considerations in the evaluation. 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 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994 available on the web at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. Investigators also may 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. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, one month before the application receipt date, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the PA 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 a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Ms. Diane Bronzert at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program contact listed under INQUIRIES with any questions regarding their proposed project. The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98). Applications will be accepted on the 9th of April, August, and December through August 9, 2002. Amended applications are due on the same receipt dates. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, Email: grantsinfo@nih.gov. Application kits are also available at: http://grants.nih.gov/grants/forms.htm. 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 (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-004.html). SEE SPECIFIC APPLICATION INSTRUCTIONS BELOW FOR MODULAR GRANT APPLICATIONS. Submit a signed, typewritten original of the application, including the checklist, and five signed, exact, single-sided photocopies, in one package directly to Dr. Suzanne Fisher at the address listed below. PLEASE NOTE THAT THIS ADDRESS IS DIFFERENT FROM THE INSTRUCTIONS IN THE 398 APPLICATION PACKAGE AND FAILURE TO COMPLY WILL RESULT IN DEFERRAL OF REVIEW. SUZANNE E. FISHER, PH.D. DIVISION OF RECEIPT AND REFERRAL CENTER FOR SCIENTIFIC REVIEW 6701 ROCKLEDGE DRIVE, ROOM 2030, MSC 7720 BETHESDA, MD 20892-7720 BETHESDA, MD 20817 (for express/courier service) SPECIFIC APPLICATION INSTRUCTIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o FACE PAGE: The title and number of the program announcement must be typed in line 2 on the face page of the application and the "YES" box must be marked. Investigators without prior R29 or R01 support are encouraged to apply for this PA and to identify their status as a new investigator on the front of the grant application. IRB approval must be obtained prior to review of the grant application or it will be deferred. Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A,) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page. See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages. At the top of the page, enter the total direct costs requested for each year. o Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Provide an additional narrative budget justification for any variation in the number of modules requested. If large patient care costs or drug acquisition costs are needed and require additional modules, provide a narrative budget justification documenting budget costs. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o RESOURCES - A description of both the clinical and laboratory facilities and resources should be included in the grant application. This includes detailed information on plans for data management, quality control of patient and laboratory data, and computer resources and plans for handling both laboratory and clinical data. If Cancer Center cores will be used for these tasks, letters of support from the appropriate individual with authority to commit the needed resources should be included in the application. Provide information on resources provided by the drug sponsor if not at your institution. o RESEARCH PLAN - Applications in response to this PA should be concise and substantially shorter than regular grant applications. ITEMS a-d MAY NOT EXCEED 15 PAGES IN TOTAL. Item a - Specific Aims - In one page or less, list in priority order, the broad, long-range objectives. Describe concisely and realistically the hypothesis to be tested and what the specific research described in this application is intended to accomplish. Item b - Background and Significance - In two pages or less, use this section to describe (a) how the proposed research will contribute to meeting the goals and objectives of the PA, and, (b) explain the rationale for the selection of the general methods and approaches proposed to accomplish your specific aims. Describe the significance of the planned studies and consider how the pilot study, if encouraging, could transition into an eventual definitive test of the therapeutic approach. Describe the innovative aspects of the studies including novel concepts, approaches, or methodologies. Do not include background material provided in the clinical protocol document but you may refer to the appropriate sections/pages of the protocol. Items c-d - Progress Report/Preliminary Studies, Research Design and Methods - In twelve pages or less, complete as instructed in the PHS 398 booklet. TO THE EXTENT THAT MATERIAL INCLUDED IN THE CLINICAL PROTOCOL IS ADEQUATE FOR REVIEW, IT NEED NOT BE REPEATED IN THIS SECTION. (The clinical protocol must be included in the Human Subjects section even if support is only requested for laboratory studies.) The investigator may use this section to address the following: o Preliminary studies pertinent to the application, o Rationale and hypothesis for the clinical trial and laboratory studies. o General methods that will be utilized, clinical, laboratory, or both, as appropriate, reason(s) for selecting these approaches, provide specific details for those techniques which are unique or where a significant departure from a generally accepted technique is important for reviewers to know, o Outcome measures that will be used to assess the success or failure of each set of experiments (include statistical analyses for laboratory and clinical studies), clinical endpoints should be discussed with particular emphasis on those aspects that may be especially complicated in clinical trials (e.g., lack of conventionally measurable disease, patients whose only evidence of disease is biochemical). o A statistical section should be included discussing the choice of the clinical trial design and laboratory analyses with power calculations. The statistician involved with the study should be identified and a letter of support included if no effort is requested on the grant application. Plans for data management and verification of research data should also be included. o Potential pitfalls in the experimental design and alternative studies that will be done if the proposed experiments fail. The Research Plans must include the following sections: Gender and Minority Inclusion for Research Involving Human Subjects - Describe the composition of the proposed study population in terms of gender and racial/ethnic group and provide a rationale for selection of such subjects. Display this proposed composition using the Inclusion Report Format provided in the PHS 398 form instructions. Participation of Children - This section should provide either a description of the plans to include children and a rationale for selecting or excluding a specific age range of child, or an explanation of the reason(s) for excluding children as participants in the research (see justifications for exclusions in the PHS 398 form instructions). o HUMAN SUBJECTS - IN ADDITION TO THE INFORMATION REQUESTED IN THE PHS 398 FORM, INCLUDE THE COMPLETE CLINICAL PROTOCOL IN THIS SECTION Informed consent form(s) must be included. NIH will treat as confidential any scientific, preclinical, clinical, or formulation data and information that the sponsor deems to be proprietary and confidential. IN ADDITION, applicants must insure that the first page of the human subjects section includes the following information: 1a) If NCI-provided agent(s) to be used: CTEP-assigned LOI # and date of CTEP LOI response letter confirming potential availability__________ 1b) If agent(s) will be provided by a company, letter is provided confirming plans to provide agents and date available__________ 1c) If this protocol is an initial IND-filing study: date IND submitted to FDA__________ 1d) None of the above (1a, 1b, or 1c) applies__________ NCI/CTEP or drug company correspondence should be included in the Appendix, as applicable. o CHECKLIST - This page should be completed and submitted with the application. If the F&A, rate agreement has been established, indicate the type of agreement and the date. It is important to identify all exclusions that were used in the calculation of the F&A, costs for the initial budget period and all future budget years. o APPENDIX - Include a maximum of 10 publications, manuscripts (submitted or accepted for publication), abstracts, patents, or other printed material relevant to this project. Include letters from appropriate drug sponsor. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applications not conforming to these guidelines will be considered unresponsive to this PA and will be returned without further review. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened by the Center for Scientific Review in accordance with the standard NIH peer review procedures. 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 applications under review, will be discussed, assigned a priority score, and receive a second level review by either the National Cancer Advisory Board or the National Advisory Committee for Complementary and Alternative Medicine. 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 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 this study address an important problem? If the aims of the application are achieved, will this be a worthwhile experiment in investigating an innovative therapeutic approach? How will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 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? Have the investigators considered how the pilot study, if encouraging, could transition into an eventual definitive test of the therapeutic approach? 3. 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 for cancer? 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 researchers (if any)? 5. Environment. Are the planned statistical and data management resources adequate? 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? 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 minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. 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. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ms. Diane Bronzert or Dr. Roy Wu Program Directors, Cancer Therapy Evaluation Program Division of Cancer Treatment and Diagnosis National Cancer Institute Executive Plaza North, Room 734 Bethesda, MD 20892 Telephone: (301) 496-8866 FAX: (301) 480-4663 Email: db85g@nih.gov or rw51j@nih.gov Dr. Richard L. Nahin Division of Extramural Research Training and Review National Center for Complementary and Alternative Medicine 9000 Rockville Pike Bldg. 31, Room 5B-58 Bethesda, MD 20892-2182 Telephone: 301-496-4792 Email: NahinR@OD.NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Jill Rogers Grants Management Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-8699 FAX: (301) 496-8601 Email: rogerj@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No 93.395, Cancer Treatment Research and 93.213, Complementary and Alternative Medicine Research. Awards are made under the authorization of the 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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