and Human Services (HHS)
EXPIRED
MOLECULAR TARGET DRUG DISCOVERY FOR CANCER: SMALL BUSINESS GRANTS Release Date: February 16, 2000 PA NUMBER: PAR-00-061 National Cancer Institute Letter of Intent Receipt Date: June 6, 2000 Application Receipt Date: July 18, 2000 PURPOSE The National Cancer Institute (NCI) defines new, extraordinary research opportunities through stated goals in a "Bypass Budget". Among the priorities of the 2001 Bypass Budget was to identify and use molecular targets for the discovery and clinical testing of new anticancer agents based on the molecular mechanisms that underlie neoplastic transformations, cancer growth and metastasis. Accordingly, the Developmental Therapeutics Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), and the Chemoprevention Agent Development Research Group, the Division of Cancer Prevention, NCI invite Small Business Innovative Research Program (SBIR) and Small Business Technology Transfer Program (STTR) applications to exploit molecular targets for drug discovery. New insights into our understanding of cancer cell biology provide a new opportunity for a fundamental re-ordering of approaches to cancer drug discovery. Rather than depending on in vitro and in vivo screens for antiproliferative activity, investigators can now focus on new molecular targets and pathways essential for the development and maintenance of the cancer phenotype. As a result, the NCI is reorganizing its drug development programs from early drug discovery phases to the conduct of clinical trials in order to bring forward new types of agents based on strong rationales. The plan also involves changes in the clinical evaluation of new agents that will include appropriate measurements to verify target modulation. In addition to the present announcement, the NCI announces three related initiatives in molecular target drug discovery for cancer treatment and prevention: Cooperative Agreement (U01) applications (see http://grants.nih.gov/grants/guide/rfa-files/RFA-CA-00-002.html) which are suitable for more mature projects defined by preliminary data, Exploratory/Development Grant (R21) awards (see http://grants.nih.gov/grants/guide/pa-files/PAR-00-060.html) for pilot projects for which preliminary data are lacking that would make the project NCI awardees (see http://grants.nih.gov/grants/guide/pa-files/PAR-00-062.html), which can be used to extend the goals of active grants to include studies related to drug discovery. See the Home Pages of either the Developmental Therapeutics Program (http://dtp.nci.nih.gov) or the Chemoprevention Agent Development Group (http://dcp.nci.nih.gov/cb) for further information or contact individuals listed under INQUIRIES of this PA. Further information on research opportunities regarding molecular targets in drug discovery can be found in the NCI ByPass Budget, The Nation’s Investment in Cancer Research: A Budget Proposal for Fiscal Year 2001 at http://2001.cancer.gov. The purpose of this Program Announcement (PA) is to reorganize the front end or gateway to drug discovery. Investigators are being asked to identify a novel molecular target, to validate the target as a basis for cancer drug discovery, or to develop an assay for the target. Given the fact that some investigators may already have considerable preliminary data on a signaling pathway, they nevertheless may not have focused on the point of greatest vulnerability in the pathway and therefore, perhaps the optimal point of drug attack. This PA would support an investigator to validate a target or to develop an assay based on the target. Applicants may address targets related to the treatment of established cancers, or the prevention of molecular changes which may cause cancer. Investigators may use their own creativity in defining their approach. For example, some may prefer to 1) use a genetic, structural biology or molecular biology approach to target identification/validation using information from genetic studies or studies of pathways, whereas others may prefer to 2) identify the function of a cellular target after first finding the target as a result of exploring binding patterns of natural products or other ligands to the novel target. The PA requires that the proposed target in each application be novel and not addressed by drugs already approved for clinical use. Since the SBIR and STTR mechanisms require the research to result in a commercial product (see "Mechanism of Support"), it would seem that projects such as assay development or combinatorial chemistry library generation to assist target validation might be more suitable than, for example, target identification. Applications submitted to the NIH will be reviewed by the NCI according to the criteria established for this PA as described below under REVIEW CONSIDERATIONS. 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, Molecular Target Drug Discovery for Cancer, is related to priority areas of human cancer treatment and prevention. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000 . ELIGIBILITY REQUIREMENTS Eligibility requirements are described in the SBIR STTR OMNIBUS SOLICITATION: http://grants.nih.gov/grants/funding/sbir.htm. Any small business, independently owned and operated by United States citizens or permanent resident aliens may apply. It must be organized for-profit, cannot be dominant in its field of expertise, and must have its principal place of business in the United States. For both Phase I and Phase II, the research or R&D must be performed in its entirety in the United States. Including any affiliates, the company can be the employer of no more than 500 people. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Support for the PA is through the SBIR and STTR mechanisms, which are set-aside programs. This is a one-time PA, which may be reissued. Unless otherwise noted, all NIH grants policies apply. Applications can be submitted for support as Phase I STTR (R41) or Phase I SBIR (R43) grants: Phase II STTR (R42) or Phase II SBIR (R44) grants, or under the SBIR/STTR FAST-TRACK option as described in the OMNIBUS SOLICITATIONS (PHS 2000-2). Phase II applications in response to this PA will only be accepted as competing continuations of previously funded NIH Phase I SBIR/STTR awards. The Phase II proposal must be a logical extension of the Phase I research. Information on the FAST-TRACK process and the OMNIBUS SOLICITATIONS are available at: RESEARCH OBJECTIVES Background The past 20 years have seen an explosion in the understanding of how cancer cells work. Specific molecules have been identified which cause the initiation and progressive growth of tumors. From this work, a fundamental re-ordering of the approach to drug discovery and development for the treatment and prevention of cancer has emerged. There is the opportunity to move away from screening agents by their effects on tumor cell growth, in vivo or in vitro, and targets that have been thoroughly exploited. While it remains true that these methods might continue to be the basis for the development of clinically useful agents, these agents may not be the best lead compounds that effect a particular pathway of biologic importance specific for cancer establishment or progression. Drugs discovered by these early methods have historically demonstrated clear limitations in clinical efficacy. The hope is that drugs targeting new, specific molecular lesions in cancer cells will provide more effective therapy or prevention approaches, alone or in combination with other agents. The focus of attention in this new approach to cancer drug discovery is a compound’s effect against a novel molecular target, or a target operating in a defined biochemical pathway, with the intent of causing a gain or loss in function to reverse, stop, or delay cancer progression. The cancer cell selectivity of lead compounds should be enhanced by screens based on a novel target or a critical pathway that represents a true Achilles heel. The evaluation of drugs in the clinic which have emerged from these types of approaches is beginning. Examples would include the farnesyl transferase inhibitors (FTIs), protein kinase (PK) antagonists of various sorts, matrix metalloprotease inhibitors, and growth factor receptor or other effector antagonists (endothelin, tamoxifen, TRAIL, etc.). It is striking that in this process the pharmaceutical industry has clearly seized a defining role in expeditiously advancing potentially useful compounds to a clinical test. However, in each of the instances cited, the pioneering studies on the targets to which these drugs are directed occurred largely (if not exclusively) in the academic sector. Objectives and Scope The goal of this PA is the discovery and/or validation of molecular targets for cancer prevention or treatment intervention which can be developed into drug discovery assays. Identification of a potential target might present varying degrees of difficulty, but validation (an indication of a target’s predictive capacity to aid in the selection of clinical drugs) is apt to be uniformly more problematic. Leads for many existing clinical drugs were not discovered through the use of macro-molecular targets but rather through in vivo or in vitro anti-proliferative assays. Accordingly, the cornerstone of this effort is the validation of targets of demonstrated importance. Projects are acceptable at all stages of development, mature projects as well as novel insights at an early investigational stage. Approaches and projects appropriate for this PA should be in one, or all, of three general areas as follows: First, investigative activities establishing a molecule as a potential cancer drug discovery target can have as its focus any aspect of early dysplasia or cancer cell biology that may reveal a vulnerability in the cancer cell. These might include cell cycle checkpoints, DNA repair, cell stress, or cell death pathways, cassettes of altered transcription factor activity, or activation of pathways allowing cell growth in hypoxic or hypo-vascularized conditions. Oncogenic viral targets also would be appropriate. In fact, any difference between a cancer and normal cell could potentially be exploitable as a therapeutic maneuver. Modern science has afforded numerous opportunities to demonstrate the likely value of this approach. These include: (1) engineered animals of various sorts (transgene-expressing, knock-out, etc.), (2) smart assays designed to give information, not only about phenotypic alteration, such as growth arrest or cell death, but also about the effect on particular molecular targets of pathways known or suspected to have biological relevance to cancer, (3) array technology, where the action of a candidate drug lead against its target can be placed rapidly in the context of expected action against other cellular and indeed organ- specific molecules, and (4) cancer gene discovery programs, such as the Cancer Genome Anatomy Project (CGAP) (http://www.ncbi.nlm.nih.gov/CGAP/), which has identified numerous mutational sites in cancer cells, some of which are possibly unique to specific types of cancer. Accordingly, a requirement is to establish that a molecular target likely affects important aspects of cancer cell function. Second, the validation of new molecular targets, with the intent of discovering new agents for the treatment or prevention of cancer, is an important and necessary activity. At present, science appears to offer too many targets. Therefore, projects should focus on determining which of these numerous potential defects are sites of critical vulnerability which could be exploited for intervention. Ideally one would expect to demonstrate that manipulation of the target function would cause a phenotypic change in the cancer cell. Clearly if a prime target is fully validated, such that the target can be used to totally exploit a unique difference between a healthy and a cancerous cell, control of cancer would then only await the discovery of a drug molecule through a systematic screening and/or drug design program, in real laboratory experience, validation occurs in stages or degrees. Demonstration of some phenotypic or functional change that is desirable, such as elimination or reversal of dysplasia, tumor shrinkage or change in a validated surrogate marker, would provide evidence of the importance of a target. Approaches to target validation might involve the use of antisense or engineered animals, such as transgene-expressing or gene knock-outs. Small, bioactive molecules, obtained either from natural products libraries or from chemical libraries, may be used as ligands to select and validate proteins from arrays. If an investigator chooses to utilize crude extracts of natural products, as from the NCI Active Repository, expertise must be available for chemical fractionation of the extracts. Thus, validation can be conceptualized as a series of milestones. A proposal to reach validation milestones could be responsive to this PA. There are many good rationales for selecting targets, but validation requires considerable imagination and skill on the part of the investigator. Therefore, also responsive to this PA would be an insightful and clever validation of a target suggested by others as a possible intervention point. While it is true that the ultimate validation can only come from a successful clinical trial, having information on the importance of the target prior to the trial should provide important feedback in case therapies are ineffective. Applicants proposing to access the Natural Products Repository of the NCI must obtain and execute the Natural Products Repository Material Transfer Agreement in advance of submitting a grant application. Similarly, applicants proposing to access the synthetic repository of the NCI must obtain and execute the synthetic Material Transfer Agreement. These agreements are available at http://dtp.nci.nih.gov (On the panel, left side, click on "Organization", select "Natural Products Branch", select "Natural Products Repository", then scroll down to and select "Material Transfer Agreement"). For information concerning the NCI synthetic or natural product repositories go to the Developmental Therapeutics web site, http://dtp.nci.nih.gov (On the panel, left side, click on "Samples and Services"). For applications involving natural products, the applicant must provide a formal statement signed by an authorized representative of the applicant institution which assures that an equitable portion of royalties or profits arising from drugs discovered, if any, will benefit 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. Plans for the procurement of proper collection and export permits must be provided. The signed document must be submitted prior to award to Dr. Gordon Cragg at the Developmental Therapeutics Program web site, http://dtp.nci.nih.gov (On the panel, left side, click on "Organization", select "Natural Products Branch" then click on "Organization/ Staff Directory"). Third, the target system should be amenable to conversion into a screen for effectors of the target’s function (at minimum on a laboratory scale), or the molecular structure determined through biophysical techniques as a prelude to drug discovery studies . These aspects are critical components which would form the thrust of any molecularly focused drug discovery effort. The practical nature of drug discovery research is of high importance. While the desirability of this approach might seem obvious, the tools for accomplishing this task are only now becoming routinely available. These include sequence information defining the primary structure of relevant target proteins or other macromolecules, expression vectors for their large scale production, biophysical (e.g. X-ray and NMR) and computational techniques to allow the determination of three-dimensional structure, advances in screening technology to allow ever increasing speed and efficiency in assessing large numbers of candidate structures, and combinatorial chemistry to generate large numbers of candidate drug structures. 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 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: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. Investigators may also obtain copies of the policy from the program staff mentioned in the GCOB web site, 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. As part of the scientific and technical merit evaluation of the research plan, reviewers will be instructed to address the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion. LETTER OF INTENT Prospective applicants are asked to submit, by June 6, 2000, a letter of intent that includes a descriptive title of the proposed research, name, address, and telephone number of the Principal Investigator, identities of other key personnel and participating institutions, and 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 subsequent applications, the information allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The Letter of Intent is to be sent to a program representative at the address listed under INQUIRIES by the letter of intent receipt date listed in the heading of this PA. APPLICATION PROCEDURES This PA must be read in conjunction with the OMNIBUS SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH GRANT (SBIR) APPLICATIONS (PHS 2000-2) and for SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS (PHS 2000-2). All of the instructions within the omnibus solicitation apply with the following exceptions: -Special receipt dates -Initial review convened by the NCI Division of Extramural Activities -Additional review considerations. Applications received in response to this PA are to be prepared as described in the OMNIBUS SOLICITATION (PHS 2000-2) for the SBIR and STTR programs. OMNIBUS SOLICITATION is available electronically through the NIH, Office of Extramural Research "Small Business Funding Opportunities" website: http://grants.nih.gov/grants/funding/sbir.htm. Hard copies, subject to availability, may be obtained from the PHS SBIR/STTR Solicitation Office, phone (301) 206-9385, FAX (301) 206-9722, email [email protected]. Helpful information in preparation of the application can be obtained: http://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf. 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 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). Applications in response to this PA are to be submitted on the applicable grant application forms as follows: SBIR Phase I - PHS 6246-1 (1/98) http://grants.nih.gov/grants/funding/sbirsttr1/index.htm STTR Phase I - PHS 6246-3 (1/98) http://grants.nih.gov/grants/funding/sbirsttr1/index.htm SBIR Phase II - PHS 6246-2 (1/98) http://grants.nih.gov/grants/funding/sbir2/index.htm STTR Phase II - PHS 6246-4 (1/98) http://grants.nih.gov/grants/funding/sttr2/index.html The application forms are also located in the back pages of the OMNIBUS SOLICITATION. Applications will be accepted up to July 18, 2000. The PA title and number must be typed in line 2 on the face page of the application form. If an application is received after the application receipt dates, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this PA that is essentially the same as one currently pending review, unless the applicant withdraws the pending application. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Applications can be submitted for Phase I or Phase II support, or as a combined Phase I and II (FAST TRACK). Phase II applications will only be accepted as continuations of previously funded Phase I grants. The Phase II proposal must be a logical extension of the Phase I research but not necessarily a Phase I supported in response to this PA. Projects may be presented for SBIR/STTR support at all stages of the target identification and validation process. Projects will be evaluated on overall innovation, strength of the approach, and probability of clinical utility, with less emphasis on the nature of the specific stage proposed in the application. PHASE I: Feasibility in the target validation process or assay development should be demonstrated. Normally, the Phase I award period is one year with an assistance of $100,000 in total costs. However, award levels are guidelines and not ceilings. Applicants may request longer periods of time and/or higher budgets with convincing justification. It would be expected, but not required, that Phase I would support relatively early discovery and evaluation projects. Phase I projects should focus on research required to advance to the next stage in the development process and present a plan and time line outlining accomplishments and milestones to be achieved at each stage. Applicants should emphasize innovative aspects of the project as well as the potential for clinical relevance. If the allowed 25 pages for Phase I projects is not sufficient, applicants should contact the Scientific Review Administrator (SRA) after receipt and assignment of the application to request approval for submission of supplementary information for review. PHASE II: Normally Phase II awards can be for up to two years and up to $750,000 in total costs per year for SBIR projects and $500,000 for STTR projects. As with Phase I, requests for larger budgets and/or longer time periods may be considered, if justification is given. FAST TRACK: Applications may be submitted for combined Phase I and Phase II, FAST TRACK consideration as described in the OMNIBUS SOLICITATION. However, due to the complex nature of the target identification and validation process, it is recommended that only well defined and more advanced projects be proposed for support through this mechanism. Phase I, FAST TRACK applications must specify clear, measurable milestones that should be achieved prior to Phase II funding. Failure to provide measurable milestones in the Phase I application and/or sufficient detail in the Phase II application may be sufficient reason for the peer review committee to exclude the Phase II from consideration. If so, the applicant may apply later for Phase II support. Such applications will be reviewed by a standing Study Section of CSR or by a special review group convened in response to a re-issuance of this PA, if applicable. Special provisions described in this PA pertaining to Phase I and Phase II also apply to FAST TRACK applications. The small business concern must submit a concise Product Development Plan (limited to five pages) as an Appendix to the Phase II application addressing the four areas described in the instructions for FAST TRACK applications in the OMNIBUS SOLICITATION. The OMNIBUS SOLICITATION indicates the normal levels of support and period of time for SBIR and STTR Phase I and Phase II awards. It is strongly recommended that applicants contact NCI staff at an early stage of application development to convey critical information, such as potentially large budgets requests or to discuss programmatic responsiveness of the proposed project. Applications requesting a budget not to exceed $100,000 total costs (direct costs, indirect costs and fixed fee) per year should use the Modular Grant format as presented in the OMNIBUS SOLICITATION. Other applicants should provide a detailed budget. SBIR Phase I applications requesting in excess of $100,000 total costs (direct costs, indirect costs and fixed fee) per year will use "Budget for Phase I Direct Costs" (form page 3 of PHS 6246-1), and justify this request using "Budget Justification" (form page 4 of PHS 6246-1). STTR Phase I applications requesting up to $100,000 total costs (direct costs, indirect costs and fixed fee) will request budgets using "Budget Justification" (form page 5 of PHS 6246-3) ONLY. Present the total amount requested for direct costs on line &a of the Face Page of PHS 6246-3. The applicant small business organization is not to submit "Budget of Applicant Organization for Phase I - Direct Costs Only" (form page 3 of PHS 6246-3), it is to be used as a "worksheet" only. However, the single, "partnering research institution must complete "Budget of Research Institution for Phase I" (form page 4) in an abbreviated manner by: (1) Entering the amount of its participation in the project under "Total Costs," and (2) Signing and dating the "Certificate of Research Institution Participation" portion of the form. STTR Phase I applications requesting in excess of $100,000 total costs (direct costs, indirect costs and fixed fee) will use "Budget of Applicant Organization for Phase I - Direct Costs Only" (form page 4 of PHS 6246-3) and justify this request using "Budget Justification" (form page 5)." Potential applicants are encouraged to contact program staff for guidance and to read the advice and information on the web sites. However, responsibility for planning, direction, and execution of the proposed research will be solely that of the applicant. The completed original application and three legible copies must be sent or delivered to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) To expedite the review process, at the time of submission, send two additional copies of the application to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8062, MSC 8239 Bethesda, MD 20892-8239 Rockville, MD 20852 (for express/courier service) Applications must be received by the receipt date listed at the top of the first page of this PA announcement. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and for adherence to the guidelines by NCI. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities of the NCI in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications 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-sponsored research are to advance our understanding of biological systems, improve the control of disease, and enhance health. Within this framework, the specific goals of this PA are the discovery and/or validation of new molecular targets with the potential for developing assays for the discovery of new agents to treat or prevent cancer. At minimum, a target should be identified (de novo, or from the literature) and/or a validation plan outlined, and a conception of how the validated target can be developed into a drug assay. Meritorious projects will include imaginative intervention points and/or insightful validation approaches, which overall will reveal an exploitable site of critical vulnerability. In considering the scientific and technical merit of each application, the following criteria will be used as described in the OMNIBUS SOLICITATION (PHS 2000-2): Significance. Does this study address an important problem? Does the proposed project have commercial potential to lead to a marketable product or process? What may be the anticipated commercial and societal benefits of the proposed activity? If the aims of the application are achieved, how will scientific knowledge be advanced? Does the proposal lead to enabling technologies (instrumentation, software, etc.) for further discoveries? Will the technology have a competitive advantage over existing/alternate technologies that can meet the market needs? Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Is the proposed plan a sound approach for establishing technical and commercial feasibility? Does the applicant acknowledge potential problem areas and consider alternative strategies? Are the milestones and evaluation procedures appropriate? Innovation. Does the project challenge existing paradigms or employ novel technologies, approaches or methodologies? Are the aims original and innovative? Investigator. Is the Principal Investigator capable of coordinating and managing the proposed SBIR/STTR? Is the work proposed appropriate to the experience level of the principal investigator and other researchers, including consultants and subawardees (if any)? Environment. Is there sufficient access to resources (equipment, facilities, etc.)? Does the scientific and technological 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? For Phase II applications: In addition to the above criteria, to what degree was progress toward the Phase I objectives met and feasibility demonstrated in providing a solid foundation for the proposed Phase II activity? For Phase I/Phase II Fast Track applications, the following additional criteria will be applied: Does the Phase I specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II? Did the applicant submit a concise Product Development Plan that adequately addresses the four areas described in Section VI. G. of the SBIR/STTR solicitation? To what extent was the applicant able to obtain letters of interest, additional funding commitments and/or resources from private sector or non- SBIR/STTR funding sources that would enhance the likelihood for commercialization? For all SBIR/STTR applications, in accordance with NIH policy, all applications will also be reviewed with respect to the following: The adequacy of plans to include both genders, 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 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. The appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA Funding decisions for Phase I or Phase II applications will be based on quality of the proposed project as determined by peer review, program priority, potential for clinical success, and availability of funds. FAST TRACK, Phase II applications may be funded following submission of the Phase I progress report and other documents necessary for continuation. Phase II applications will be selected for funding based on the initial priority score, NCI"s assessment of the Phase I progress and determination that Phase I goals were achieved, the project"s potential for commercial success, and the availability of funds. INQUIRIES Inquiries concerning this PA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues in cancer treatment and inquiries regarding access to the Natural Products Repository to the appropriate individuals given in the GCOB web site: http://dtp.nci.nih.gov/ (On the panel, left side, click on "Funding", then scroll down to "Staff") Direct inquiries regarding programmatic issues in cancer prevention to the DCP web site: http://dcp.nci.nih.gov/cb Direct inquiries regarding review issues to: Ms. Toby Friedberg Referral Officer Division of Extramural Activities National Cancer Institute 6116 Executive Boulevard, Room 8062, MSC 8239 Bethesda, MD 20892-8239 Rockville, MD 20852 (for express/courier service) Telephone (301) 496-3428 Fax: (301) 402-0275 Email: [email protected] Direct inquiries regarding fiscal matters to: Ms. Kathleen Shino Grants Administration Branch National Cancer Institute Executive Plaza South 243 Bethesda, MD 20892-7150 Telephone: (301) 496-8635 Fax: (301) 496-8601 Email: [email protected] 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 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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