Full Text CA-95-020 NATIONAL COOPERATIVE DRUG DISCOVERY GROUPS NIH GUIDE, Volume 24, Number 33, September 22, 1995 RFA: CA-95-020 P.T. 34 Keywords: Cancer/Carcinogenesis Chemotherapeutic Agents Biomedical Research, Multidiscipl National Cancer Institute Letter of Intent Receipt Date: October 1, 1995 Application Receipt Date: December 20, 1995 PURPOSE The Developmental Therapeutics Program, Division of Cancer Treatment, National Cancer Institute (NCI) invites applications for the continuance of the National Cooperative Drug Discovery Group (NCDDG) and National Cooperative Natural Products Drug Discovery Group (NCNPDDG) Programs for the discovery of new and more effective anticancer treatments. Applications are sought from both recompeting NCDDGs and NCNPDDGs as well as from new applicant Groups. This Request for Applications (RFA) will support broad, innovative, multidisciplinary approaches to the discovery of new, rationally based (NCDDG) or natural-source derived (NCNPDDG) anticancer treatments. A multi-institutional approach involving academic, nonprofit, and/or commercial/industrial institutions is envisioned because the creative talents in the required scientific disciplines will rarely be available in only one institution. The active participation of industry is encouraged because it will allow this segment of the scientific community to contribute its considerable intellectual and material resources. Further, the interaction of academic and non-profit research institutions with industry and Government will facilitate subsequent development and marketing of new therapies, although these latter activities are not within the scope of this RFA. The present RFA is a reissuance of CA-94-007 and CA-94-008, which were released on June 3, 1994. The "Research Objectives" of the RFA require that an NCDDG or NCNPDDG has the capacity within itself to discover and evaluate new entities and strategies for the treatment of cancer. Biological or molecular targets for drug discovery, and, for the NCNPDDG program, the sources and types of natural products to be investigated, will be selected by the applying Group. For the NCDDG program either mechanism of action or disease-oriented approaches are being solicited. Although this RFA does not support clinical trials, a timely evaluation of products discovered by the Groups is encouraged. Subsequent studies required for development of new treatments and progression to clinical trial (e.g., formulation development, large-scale production for clinical trials, or toxicology in support of Investigational New Drug Applications, etc.) are beyond the scope of this RFA. The development of analogs of established anticancer agents is not responsive to this RFA. 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 RFA, National Cooperative Drug Discovery Groups, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign 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 support of awards will be a cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NCI purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreement(s) are discussed later in this document under the section "Terms and Conditions of Award." Assistance via cooperative agreement differs from the research project grant in that the Government component (NCI) awarding the cooperative agreement anticipates substantial programmatic involvement during performance of the award. This partnership relationship will facilitate technology transfer from Government-owned data bases and the use of appropriate NCI-derived resources to enhance the efficiency and effectiveness of a Group's efforts. The nature of NCI staff participation is described below under "Terms and Conditions of Award". There is no intent, real or implied, for NCI staff to direct Group activities or to limit the freedom of investigators. Award will be made only to the Principal Investigator's institution. All Group activities will be coordinated through an administrative core located at the Principal Investigator's institution. The total project period for applications submitted in response to the present RFA may not exceed five years. The earliest anticipated award date is August 1, 1996. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of awards will vary also. The number of awards and the level of support depend on receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. At this time, the NCI anticipates that there will be a renewed competition of this program. However, if the NCI does not continue the program, awardees may submit grant applications through the usual investigator-initiated grants program. FUNDS AVAILABLE The NCI has set aside approximately $3.5 million total costs (direct plus indirect costs) for the first year of funding. This level of support is dependent on the receipt of a sufficient number and diversity of applications with high scientific merit. It is anticipated that three or four NCDDG and one or two NCNPDDG awards will be made for periods up to five years. Awards are subject to a first year limit of $900,000 in total costs. Budget requests should be carefully justified and commensurate with the needs of the project. Applications in excess of $900,000 total costs for the first year will be returned without review. Annual budgets for years two to five cannot exceed $900,000 plus a four percent yearly increase. RESEARCH OBJECTIVES Background Important new discoveries in molecular biology, embryology and related fields, together with major technological advances, permit the design of highly selective and specific approaches to discovery of new cancer therapies. Exploitation of these exciting advances for development of more effective cancer therapy requires the organization of outstanding scientists from diverse scientific disciplines within the biological, chemical, and pharmacological sciences into highly synergistic research teams without regard to institutional affiliation. To realize this objective, as well as to utilize facilitating resources of NCI's drug development program within these teams, the NCI established, in 1983, on advice of a special subcommittee of the Division of Cancer Treatment's Board of Scientific Counselors, the National Cooperative Drug Discovery (NCDDG) program. The NCDDG was initiated by Requests for Applications (RFAs) issued in July 1983 and August 1984 for the exploitation of mechanistically based differences between normal and cancer cells. October 1986 reissuances established groups focused on exploitation of specific and unique characteristics of lung and colorectal cancers. The NCDDG approach to modern drug discovery was broadened further in August 1987 by RFAs inviting applications for the creation and evaluation of both the general mechanism of action based and the specific disease oriented anticancer treatments as well as for the development of innovative preclinical models. Combined RFAs were issued in August 1991 and March 1994 for general mechanism of action and specific disease oriented research. National Cooperative Natural Products Drug Discovery Groups (NCNPDDGs) were established through RFAs issued in September 1988 and October 1989 with a reissuance in March 1994, to enhance discovery of novel chemotypes from natural sources for subsequent development as anticancer agents. NCDDGs and NCNPDDGs are peer-reviewed projects funded as cooperative agreements. The cooperative agreement is a mechanism in which the NCI, through its extramural staff, is an active partner in the group. NCI staff, represented by a Project Coordinator appointed after award, provide advice and guidance in the area of drug discovery and development and facilitate access to NCI resources including repositories, chemical searches, and screens. Resources for advanced development including scale-up synthesis, pharmaceutics, toxicology, Investigational New Drug Applications (INDAs) to the Food and Drug Administration (FDA), and clinical trials support can be made available through the NCI Decision Network process (M.R. Grever, S.A. Schepartz, and B.A. Chabner, Seminars in Oncology, Vol. 19, No. 6 (December), 1992: pp 622-638) or through private venture capital. Objectives and Scope The purpose of this RFA is to encourage the discovery of novel therapies and therapeutic strategies to improve the survival of cancer patients. Projects organized for both the NCDDG and NCNPDDG programs should utilize, to the extent possible, novel and innovative approaches to drug discovery based on recent advances in tumor biology and the molecular understanding of cancer. Approaches to targets specifically altered in tumor cells are encouraged. It should be emphasized that approaches to realization of the goals of this RFA are broad and limited only by the creativity and scientific abilities of the applicants. Applications with relevance to high priority diseases, such as breast and prostate cancer, are encouraged, but this RFA is not meant to exclude any approach or disease type. Rather, the emphasis is on creative ideas. Applications could include approaches to chemical modification of leads, but it should be emphasized that discovery of new agents and not modification of known structures should be the primary focus of the Group activities. Preclinical evaluation that will facilitate decisions regarding potential clinical efficacy of agents discovered should be included. NCDDG projects should emphasize new drug design strategies based on recent advances in tumor biology and new technology appropriate for cancer drug discovery. Specific approaches could encompass a wide range of topics such as new combinatorial libraries or computer modelling of receptor targets. Other examples appropriate for the NCDDG program include, but are not limited to, gene therapies, monoclonal antibodies, and vaccines; design of agents to interfere with transcription factors, signal transduction, cell adhesion factors, angiogenesis, intracellular hormone or other receptors; and other novel targets involved in the initiation and/or maintenance of the transformed state and for which a strong rationale can be provided. NCNPDDG projects should focus on the discovery and evaluation of new entities from natural sources for the treatment of cancer. Programs should utilize to the extent possible, novel and innovative approaches to drug discovery based on recent advances in tumor biology and the molecular understanding of cancer. Programs appropriate to fulfillment of these objectives include, but are not limited to, discovery of natural products which selectively inhibit specific tumor types, products that may affect oncogene expression in tumors, signalling pathways, or the actions of hormones or growth factors on proliferation. The development or use of preclinical models based on their ability to discriminate for antitumor activity and to test the rationale for natural product selection and isolation are encouraged. Projects for random collection and screening of natural products extracts without strong rationales for material selection or testing models and projects designed to produce analogs of known antitumor natural products are not responsive to this RFA. Applications should stress novelty of approach and strong rationale both in terms of the cancer target and the natural products to be evaluated. Applications for NCDDG and NCNPDDG should stress creative approaches to the discovery of effective anticancer therapies and should emphasize the following: o Objectives of the proposed NCDDG or NCNPDDG project. o Research approaches to the realization of objectives and the provision of comprehensive information (including citations) in support of the rationale(s) for the proposed approaches. o Specific relevance to cancer treatment. o The scientific and technical areas of expertise (Program Leaders) required to attain Group objectives. Funds for projects or cores that depend on the successful completion of other activities, such as the availability of certain reagents or scale up synthesis, could be included, but use of such funds will be restricted and released only on specific approval of the NCI Program Director. Inclusion of such funds cannot exceed the total costs cap of $900,000 plus four percent annual increase. Definitions ADMINISTRATIVE CORE. An administrative unit located at the Principal Investigator's institution that coordinates all Group activities. It is separately budgeted from the PI's Laboratory Program (if any) and budgets for activities pertinent to the Group as a whole. CORE LEADER. The director of a scientific core component who is responsible for the conduct of that core. DRUG. In the context of this RFA, a term used broadly to encompass synthetic agents and biological products, as well as novel therapeutic strategies and inventions designed to treat and cure cancer. Strategies also encompass creative methods to maximize antitumor selectivity. GROUP. See NCDDG and NCNPDDG, below. LABORATORY PROGRAM. A research component headed by a Program Leader within an NCDDG or NCNPDDG with a separate, detailed research plan and budget. NATIONAL COOPERATIVE DRUG DISCOVERY GROUP (NCDDG). A unit consisting of a Principal Investigator, Program Leaders, Core Leaders (if any), their respective programs, and an NCI Coordinator (appointed after award) which functions as a unit with a common goal: the conceptualization, invention, and evaluation of new entities and strategies for treatment and cure of cancer. In this RFA, the terms NCDDG and Group are used synonymously. NATIONAL COOPERATIVE NATURAL PRODUCTS DRUG DISCOVERY GROUP (NCNPDDG): A number of Laboratory Programs representing diverse scientific disciplines and usually multiple organizations which consist of a Principal Investigator, Program Leaders, Core Leaders (if any) and the NCI Coordinator which functions as a unit with a common goal: the rational selection, isolation, and evaluation of new entities from natural sources for treatment of cancer. As with the NCDDG (above), the terms NCNPDDG and Group are used synonymously. NATURAL PRODUCT: In the context of the NCNPDDG program, a term used broadly to encompass any naturally occurring chemical or biological entity of non-human origin selected and evaluated preclinically against cancer. This, of course, excludes materials which are synthesized de novo by the investigators and also excludes semi-synthetic derivatives of known antitumor agents. NCI COORDINATOR. A scientist from the NCI extramural program staff, appointed after award by the NCI Program Director, who participates as a member of the Group, interacts scientifically with the Group and facilitates the role of NCI as partner in the Group. The Program Director also may serve as the NCI Coordinator for a Group. NCI PROGRAM DIRECTOR. The senior staff member of the Grants and Contracts Operations Branch, Developmental Therapeutics Program, Division of Cancer Treatment who provides leadership and guidance for the overall NCDDG and NCNPDDG Programs within the NCI, maintains overall scientific balance in the NCDDG and NCNPDDG Programs, and ensures that the NCDDG and NCNPDDG Programs are consistent with the NCI mission for treatment research. PROGRAM LEADER. A senior scientist with proven independent research capabilities who serves as director of one of the scientific Laboratory Programs of the Group and is responsible for the scientific conduct of that program. The Principal Investigator of the Group may be a Program Leader. SCIENTIFIC CORE. A separately budgeted scientific service component which provides essential facilities or services to two or more of the proposed Laboratory Programs. Core components typically use established procedures or protocols rather than generating new research. SPECIAL REQUIREMENTS A. The Group's objectives and goals should be relevant to and compatible with the NCI's mission in cancer treatment as stated in this RFA. Applicants should describe their plans to accommodate the stated NCDDG or NCNPDDG requirements, criteria, and NCI involvement. B. All proposed Groups must consist of at least three interrelated projects, which are called Laboratory Programs in this RFA. While no maximum number of programs is stipulated, when an award exceeds five programs the overall Group becomes more difficult to manage. Groups may also have scientific cores which provide essential services to two or more Laboratory Programs, but a core cannot serve as one of the three Laboratory Programs. C. The Principal Investigator and each Program Leader should provide a signed statement of acceptance of the participation of NCI staff during performance of the award as outlined under "NCI Staff Responsibilities" below. D. A plan should be provided for those developmental activities required for introduction of an agent into clinical trial but not supported by this RFA for those agents identified as potentially worthy of clinical evaluation. E. PATENT COVERAGE Since the discovery of new and improved anticancer treatments is the objective of this effort and active involvement by industrial laboratories is facilitated by the existence of adequate patent coverage, it is essential that applicants provide plans to assure such coverage. The situation could be complicated since multiple institutions are likely to be involved. Each applicant Group must therefore provide a detailed description of the approach to be used for obtaining patent coverage and for licensing where appropriate, in particular where the invention may involve investigators from more than one institution. Procedures must be described for resolution of legal problems should they arise. Your attention is drawn to P.L. 96-517 as amended by P.L. 98-620 and 37 CFR Part 401. Instructions were also published in the NIH GUIDE FOR GRANTS AND CONTRACTS, Vol. 19, No. 23, June 22, 1990. NOTE: A formal statement of Patent Agreement among all Group members and their institutions as well as a detailed description of procedures to be followed for resolution of legal problems which may develop, signed and dated by the organizational official authorized to enter into patent arrangements for each Group member and member institution is preferred with the application. If this signed agreement is not included in the application, it must be submitted to the Scientific Review Administrator, Division of Extramural Activities, NCI prior to peer review. For NCNPDDG applications a formal statement of agreement should be provided signed by authorized representatives of all institutions in the Group, assuring that an equitable portion of royalties or profits arising from drugs discovered, if any, will be returned to indigenous peoples, research collaborators, research institutions or Governmental entities as appropriate, in the country of origin of the natural product sample from which the drug was derived. If this signed agreement is not included with the application, it must be submitted to the Scientific Review Administrator prior to peer review. F. The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. Terms and Conditions of Award NOTE: Failure to abide by any of the Terms of Award pertaining to awardee responsibilities stipulated in this Section may result in a reduction of funding, withholding of support, suspension or termination of the award. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement (U19), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee for the project as a whole, although specific tasks and activities in carrying out the studies will be shared between the awardee and the NCI Coordinator. 1. Awardee Rights and Responsibilities a. The Principal Investigator, Program Leaders, and NCI Coordinator will meet periodically to review progress, plan and design research activities, and establish priorities. The frequency of meetings, not fewer than two per year, will be determined by the Principal Investigator who will be responsible for scheduling the time and place (generally at one of the performance sites) and for preparing concise proceedings or minutes (two or three pages)which will be delivered to the members of the Group within 60 days of the meeting. NCI staff may not chair Group meetings. b. The Government, via the NCI Coordinator, will have access to data generated under this cooperative agreement and may periodically review the data. However, the awardee will retain rights to the data, and timely publication of major findings by the Group members is encouraged. Publication or oral presentation of work done under this agreement will require appropriate acknowledgement of NCI support, including the assigned cooperative agreement award number. Dissemination of information on synthetic or natural substances supplied to the Group by NCI (e.g., for comparative testing purposes, as reference material, etc.) will require clearance by NCI to assure conformity with existing confidentiality agreements with suppliers. c. For NPNCDDGs, ownership of natural product samples acquired during the course of the research rests with the Group. The Group should formulate a policy for final disposition of the samples and ownership rights in the event that the samples are transferred to the other parties who make discoveries using them. In order that the samples be fully evaluated for anticancer potential and anti-AIDS activity after the Group has concluded its evaluation but before the samples are transferred to other parties for evaluation in other therapeutic areas, it is requested that the Group provide lists of completed samples to the NCI coordinator, who will arrange for review of these lists by NCI staff involved in the Developmental Therapeutic Program's screening for anticancer and anti-AIDS activities. Should selected samples be of interest to the NCI, the Group is requested to provide these to the NCI for evaluation before release of samples for other purposes. d. The NCI recognizes that most countries, and in particular developing countries, retain interests in samples collected in their domains. All applicants who propose foreign collections of natural products must provide a plan, signed by authorized representatives of all Group member institutions, for equitable return of a portion of any profits or royalties derived from NCNPDDG discoveries to indigenous peoples, research collaborators, cooperating institutions or Governmental entities in the countries of origin, as appropriate to their contributions. 2. NCI Staff Responsibilities NCI shall participate as a member of the Group and will be represented by a Coordinator. The NCI Coordinator will be selected after award by the NCI Program Director for the NCDDG Program from the extramural but not the intramural senior staff. During performance of the award, NCI may provide appropriate assistance by participating in the design of activities; advising in the selection of sources for resources, staff, etc.; advising in management and technical performance; and participating in the preparation of publications. In all cases, the role of NCI will be to assist and facilitate and not to direct activities. The NCI Coordinator, as well as any other Group member, may assist in research planning; may suggest studies within the scope of the Group's objectives and research activities; may present to the Group experimental findings from published sources or from contract projects in support of these suggestions; may participate in the design of experiments agreed to by the Group; and may participate in the analysis of results. However, the NCI Coordinator will not conduct laboratory studies. Upon recommendation of the NCI Coordinator, NCI may utilize its drug development resources in support of Group research activities when such resources may be required on an occasional basis. The following is a list of some resources that might be supplied if they become desirable during performance, are not anticipated as a continuing need, and are readily available: a. Reference compounds for standardization of test systems, as analytical standards, and for related purposes. b. Needed resources such as test materials and information that may not otherwise be available to the Group. c. Data from testing conducted in resource contract laboratories. d. Laboratory testing capacity, whenever appropriate and possible, in the current contract based preclinical therapy related laboratory testing program. The Group is expected to provide sufficient test material for such testing. e. Searches of computer files of materials, chemical structures and biological activity, if requests for such searches are sufficiently focused to avoid excessive costs. Information given to a Group will be restricted by any standard confidentiality agreements between the Government and suppliers of test materials to the Government. f. Experimental animals and cultured cells, if available, to Groups whose main research activities do not require these materials on a regular basis. Groups whose experimental approach involves studies that require animals on a regular basis must budget for these costs in their application. g. Computer processing and statistical evaluations if costs are not excessive. These "Terms and Conditions of Award" require that the NCI Program Director approve the following: changes in the Principal Investigator or Program Leaders; reports intended for inclusion in INDAs and Clinical Brochures; redistribution, outside the NCDDG, of biological and chemical materials received from the Government; and dissemination of research findings resulting from the use of such materials. 3. Collaborative Responsibilities a. The principal end product of NCDDG and NCNPDDG activities will be the discovery of new entities and strategies for development to clinical trial. Subsequent developmental work through private resources is encouraged. Alternatively, the Group may recommend that development be sponsored by NCI. In the latter case, it will be necessary for the Principal Investigator and NCI Coordinator to cooperate in the analysis, summarization, preparation, and presentation of data to the appropriate NCI staff, such as the NCI Decision Network Committee. b. NCI will retain the option to cross-file or independently file an application for investigational clinical trial (e.g., an Investigational New Drug Application [INDA] to the United States Food and Drug Administration) of any invention resulting from these NCI supported Cooperative Agreements. Reports of data generated by the Group or any of its members required for inclusion in INDAs and Clinical Brochures and for cross-filing purposes will be submitted promptly by the Principal Investigator to the NCI Coordinator upon request. Such reports will include background information, methods, results, and conclusions. They will be subject to approval and revision by NCI and may be augmented with test results from other Government sponsored projects prior to submission to the appropriate regulatory agency. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between the awardee and the NCI may be brought to arbitration. An arbitration panel will be composed of three members: one Group designee, one NCI designee, and a third designee with expertise in the relevant area chosen by the other two. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable 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 research. This new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations) which have been in effect since 1990. The new policy contains some new provisions that are substantially different from the 1990 policies. All investigators proposing research involving human subjects should read the "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," which was reprinted in the Federal Register of March 28, 1994 (59 FR 14508-14513), and reprinted in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume 23, Number 11. Investigators may obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by October 1, 1995, a letter of intent that includes a descriptive title of the overall proposed research; the name, address, telephone number, and institution of the Principal Investigator; names of prospective Program Leaders, other key investigators, and their respective institutions; title and Program Leader for each Group Program; and the number and title of the RFA in response to which the application may be submitted. Although the letter of intent is not required, is not binding, and is not a factor in the peer review of the application, the information it contains is helpful in planning for the review of applications. It allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review process. The letter of intent is to be sent to: George S. Johnson, Ph.D. Division of Cancer Treatment National Cancer Institute Executive Plaza North, Suite 832 6130 Executive Boulevard, MSC 7450 Bethesda, MD 20892-7450 Bethesda, MD 20852 (for express/courier service) APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these awards. These forms are available at most institutional offices of sponsored research or from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, Room 3032, MSC 7762, Bethesda, MD 20892-7762, telephone (301) 710-0267. Because of the multidisciplinary and likely multi-institutional nature of an NCDDG or NCNPDDG and the special requirements in this RFA, additional written suggestions regarding format will be provided by Dr. George S. Johnson at the address listed under INQUIRIES. Potential applicants are urged to obtain the "Special Instructions to Applicants" to avoid omitting essential information and to expedite review. If required information is not contained within the application, the application will be returned without review. On line 2 of the face page of the application form, the YES box must be marked, the Number must be listed as RFA CA-95-020 and the Title should be given as "National Cooperative Drug Discovery Groups"; a personalized title more fitting for the application should be listed on line 1. The RFA label available in the PHS 398 (rev. 5/95) 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 with the result that it may not reach the review committee in time for review. Submit a signed, typewritten original of the application, including the Checklist, and three signed, photocopies, in one package to: Division of Research Grants 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 Referral Officer National Cancer Institute 6130 Executive Boulevard Executive Plaza North, Room 636 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Applications must be received by December 20, 1995. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) 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 DRG 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 include an introduction addressing the previous critique. REVIEW CONSIDERATIONS General Considerations All applications will be judged on the basis of the scientific merit of the proposed project and documented ability of the investigators to meet the RESEARCH OBJECTIVES of the RFA. Although the technical merit of the proposed studies is important, it will not be the sole criterion for selection. Other considerations, such as the likelihood of identifying a clinical trial candidate, will be part of the evaluation criteria. Applications should provide a plan for development even though some of the activities will be beyond the scope of the RFA. Review Method Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If NCI staff find that the application is not responsive to the RFA, it will be returned without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. As part of the initial merit review, all applicants will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria o Scientific merit and originality of proposed research. o Extent of progress on prior award (RECOMPETING GROUPS) or preliminary results (NEW APPLICANTS). o Extent and effectiveness of cooperation with the NCI (RECOMPETING GROUPS) and adequacy of plans for cooperation with the NCI in the event of an award (ALL APPLICANTS). o Technical merit of proposed methods for producing or obtaining test materials and for their evaluation. o Adequacy of the developmental plan for recommending a new cancer therapy or strategy for clinical trial. o Adequacy of the scientific disciplines and specific competencies represented by the Principal Investigator and Program Leaders; research experience, competence, commitment, and time availability of Principal Investigator, Program Leaders, and other key personnel. o Leadership, scientific ability, and administrative experience and competence of Principal Investigator in the development, implementation, and management of comprehensive research programs. o Adequacy of plans for effective intra-Group communication and for ensuring Group cohesiveness. o Evidence of approval and commitment of institutions represented by Group members to Group goals. o Evidence of availability and competence of the applying institution to serve as the Administrative Core for the Group. o Adequacy of existing physical facilities and resources of the Principal Investigator and Program Leaders. o Justification and usefulness of cores to the overall Group. o Adequacy of plans to include both genders and 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. The review group will critically examine the budget requested and will recommend an appropriate budget and period of support for each approved application. AWARD CRITERIA Applications recommended by the National Cancer Advisory Board (NCAB) will be considered for award based on scientific merit as reflected in the priority score; on programmatic priorities and relevance; on program balance; and on funds available. Letter of Intent Receipt Date: October 1, 1995 Application Receipt Date: December 20, 1995 Scientific Review Date: March 1996 NCAB Meeting Date: May 1996 Earliest Award Date: August 1, 1996 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 and requests for the "Special Instructions to Applicants" on application format to: George S. Johnson, Ph.D. Division of Cancer Treatment National Cancer Institute Executive Plaza North, Suite 832 Bethesda, MD 20892-7450 Telephone: (301) 496-8783 FAX: (301) 496-8333 or (301) 402-0831 Email: johnsongpax2.ncifcrf.gov Direct inquiries regarding fiscal or administrative matters to: Ms. Joan Metcalfe Grants Administration Branch National Cancer Institute Executive Plaza South, Suite 242 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, Ext. 228 Email: metcalfj@gab.nci.gov AUTHORITY AND REGULATIONS This program is described in the catalog of Federal Domestic Assistance No. 93.395, Cancer Treatment Research. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR Parts 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The Public Health Service strongly encourages all grant 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 case, 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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