and Human Services (HHS)
EXPIRED
INNOVATIVE TOXICOLOGY MODELS FOR DRUG EVALUATION: EXPLORATORY/DEVELOPMENTAL GRANTS (R21, R33) AND PHASED INNOVATION AWARD (R21/R33) Release Date: October 25, 2000 PA NUMBER: PAR-01-003 National Cancer Institute Letter of Intent Receipt Dates: December 7, 2000 and October 10, 2001 Application Receipt Dates: January 11, 2001 and November 14, 2001 THE PA INCLUDES MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. THIS PA DOES NOT USE THE MODULAR GRANT CONCEPT. PURPOSE Recent advances in cancer biology, molecular biology, combinatorial chemistry, and screening technology provide unprecedented opportunities for discovery of new agents for the treatment and prevention of cancer. Drug discovery can now be focused on specific molecular or regulatory sites within the cancer cell. The National Cancer Institute (NCI) considers exploitation of this knowledge and technology for discovery of new cancer therapies a high priority as stated in its "Bypass Budget" (http://2001.cancer.gov). It is expected that research focused on discovery and validation of new targets and screening design efforts to identify agents that affect these targets will result in a multitude of new chemical and biological agents with potential for clinical benefit. However, before such agents can be tested and used widely in patients, safety and acceptable toxicity to critical organs must be demonstrated. Current practices and procedures for safety evaluations are costly and time consuming. Developments in genomics and proteomics will provide new approaches to evaluate quickly and effectively the expected large numbers of new agents. This Program Announcement (PA) encourages the development, standardization, and validation of new and innovative assays which determine or predict specific organ toxicities (e.g., cardiotoxicity, gastrointestinal toxicity, hepatotoxicity, nephrotoxicity, ototoxicity, bladder toxicity, neurotoxicity, pulmonary toxicity, and endocrine toxicity, including pancreatic beta cell toxicity) of potential cancer therapeutic agents. Agents that have been evaluated in both animals and man can be utilized retrospectively to validate the utility, sensitivity, and reproducibility of the assay and to determine if other factors such as agent stability, protein binding, or metabolic activation are important parameters for interpretation and validation of the assay. Through a separate PA, PAR-01-004 (http://grants.nih.gov/grants/guide/pa-files/PAR-01-004.html), the NCI is inviting applications for SBIR and STTR support, focusing on the same research areas as described in the RESEARCH OBJECTIVES section of this solicitation. Qualified applicants are strongly encouraged to consider responding to the SBIR/STTR program announcement. SBIR and STTR application information is available at the following website: http://grants.nih.gov/grants/funding/sbir.htm Potential applicants who believe that they may be eligible for the SBIR/STTR award should contact the NCI staff listed under INQUIRIES to discuss this issue. In addition, potential applicants are encouraged to access the PHS SBIR and STTR OMNIBUS SOLICITATION for information on eligibility requirements at the following website: http://grants.nih.gov/grants/funding/sbirsttr1/index.htm This solicitation will utilize the R21, R33, and the R21/R33 combined Phased Innovation Award mechanisms. Specific features of the Phased Innovation Award mechanism include: o Single submission and evaluation of both the R21 and R33 as one application. o Expedited transition of feasibility phase to development phase. o Flexible budgets. o Flexible staging of feasibility and development phases. The use of the multiple mechanisms will allow projects to be submitted at various stages of development. The R21 will provide support for projects in early stages of development where there is little or no preliminary data available and it is difficult to predict success sufficiently to develop an extended R33 phase. The R33 will provide support for projects in which feasibility has been demonstrated and thus are ready for extended development. The combined R21/R33 will provide support for projects which require feasibility demonstration, and the aims and milestones of the R21 are sufficiently predictable to consider the extended R33 phase. This PA will expire on November 15, 2001. NIH Grants policies apply to these awards. RESEARCH OBJECTIVES Background Recent advances in all branches of medical sciences provide new insight into the underlying mechanisms in malignancy and suggest new targets and approaches for cancer therapy and prevention. Drug discovery can now be focused on targeting key regulatory pathways or specific macromolecules relevant to cancer. For example, key growth regulatory pathways and genes mutated in cancer cells are being identified, array technology for expression of thousands of genes as well as computer-assisted evaluation of data are available. New technologies in chemistry which allow facile synthesis of millions of new chemicals, and high resolution structures of important target proteins are becoming available. These advances taken together and coupled with high throughput screening allow identification of hundreds and maybe thousands of agents which could be seriously considered for clinical evaluation. Translation of these new technological discoveries and innovations into clinical benefit for the cancer patient through these newly discovered agents is essential, however, the later stages in this drug development process are lengthy and costly. Obviously new procedures are necessary to decide which of the multitude of new agents should be tested in humans. It is reasonable to consider that new technological advances which lead to discovery of the new agents could likewise be exploited to expedite the development and decision process. Investigations focusing on the hazards of potential cancer or AIDS drugs or biologicals to healthy organs in intact experimental animals are the final steps in the preclinical stages of new drug development. Data generated from these studies on each new drug are evaluated in light of potential human toxicity and form a major portion of the information required by the Food and Drug Administration (FDA) for an Investigational New Drug (IND) application. Preclinical toxicology studies are generally conducted in two animal species with the following objectives: to define the Maximum Tolerated Dose (MTD), Dose Limiting Toxicities (DLTs), schedule-dependency of toxicity, reversibility of adverse effects, and a safe clinical Starting Dose (SD). Procedures to obtain such information for IND filing have significant limitations in aspects such as cost and time requirements as well as prediction of problems to be encountered when agents are administered to humans. For example, since animal studies are very expensive and time- consuming, it is generally impractical to evaluate numerous analogs of a class of compounds in a species prior to selection of the best developmental candidate or to decide which of a multitude of "hits" identified from screening models should be brought to clinical evaluation. Another concern is the lack of information gained from these toxicological studies in regard to molecular or mechanistic mechanisms for observed toxicities. It cannot be determined if toxicities of new agents designed to attack a key molecular target are related to actions of inhibition of that target or to other unknown aspects of the drug"s action in various organs. New technology to improve toxicology approaches and define toxicity at the molecular level are emerging, but as yet none has been validated and accepted for common use. For example, bacterial strains and transgenic mice have been engineered to detect mutational activities of agents. "Toxicogenomics", e.g., analysis of the gene transcription profile in a cell or organ following toxic agent administration [Molecular Carcinogenesis 24:153-159 (1999)] is under development using a variety of approaches, including DNA arrays. Data analysis software programs are being written to predict toxicological endpoints. Individually, these activities may not be sufficient, but they may be highly valuable when combined with other approaches to develop a total toxicological profile of specific organ toxicity and molecular mechanisms responsible for this toxicity. Objectives and Scope The goal of this PA is the discovery, development and validation of new assays and procedures to determine quickly and cheaply toxicological profiles of potential cancer drugs. It is expected that a molecular definition of toxicity in the affected organ, tissue or cell would be a component of the procedure. Approaches for new toxicology assays in response to this initiative are broad and are determined by the creativity of the applicant. Genetically modified animals or cell lines, various non-mammalian organisms, in vitro assays utilizing primary mammalian cells, tissue slices, isolated organs, sub-cellular fractions or purified enzymes could be utilized for the model. Computer modeling utilizing existing biological and toxicological data bases would be appropriate. Genomic and proteomic technology could be exploited to profile total gene activity or protein expression and thereby establish molecular correlations with specific toxicities. Molecular endpoints to evaluate toxicity and high throughput toxicity screening could be used to help decide which agent of a chemical series should be pursued, to allow exploration of toxicity at an earlier stage in drug development, or to define the toxicity profile of agents selected for clinical trial. The NCI, through the Developmental Therapeutics Program: http://dtp.nci.nih.gov, on occasion utilizes its internal resources to foster drug development. For this PA, toxicology data from previous drug development sponsored by NCI may be made available to awardees. For additional information contact Dr. Adaline C. Smith at the address listed under INQUIRIES. The overall objective of this PA is to provide a flexible funding mechanism to support the research activities required to develop and validate innovative toxicology assays. MECHANISM OF SUPPORT Support for this program will be through the National Institutes of Health (NIH) Exploratory/Developmental Research Grant (R21), the Exploratory/Developmental Research Grant Phase 2 (R33) and the Phased Innovation Award (R21/R33 combined). The R33 is a newly established NIH grant mechanism to provide a second phase for the support of innovative exploratory and development research initiated under the R21 mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Except as otherwise stated in this PA, awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement, NIH Publication No. 99-8, October 1998. Under this PA, applicants can submit either an R21, a combined R21/R33, or an R33 application alone if feasibility can be documented, as described in the APPLICATION PROCEDURES section of this PA. The total project period for an application submitted in response to this PA may not exceed the following duration: R21, 2 years, R33, 3 years, combined R21/R33 application, 4 years. In the combined application the R21 phase cannot extend beyond 2 years. The R21 phase, either as a single application or as part of a combined R21/R33 application, may not exceed $100,000 direct costs per year except to accommodate Facility and Administrative (F&A) costs to subcontracts to the projects. Although the R33 application has no official budgetary limit, applications requesting in excess of $500,000 dollars direct costs in any single year of the grant period require prior approval before submission. It is strongly recommended that applicants contact NCI staff at an early stage of application development to convey critical information, such as potentially large budget requests or to discuss programmatic adherence to the guidelines of the proposed project. Refer to the INQUIRIES sections of this PA for NCI staff contacts. The combined R21/R33 application offers two advantages over the regular application process: 1. Single submission and evaluation of both the R21 and the R33 as one application. 2. Minimal or no funding gap between R21 and R33. The award of R33 funds will be based on program priorities, on the availability of funds and on successful completion of negotiated scientific milestones as determined by NCI staff in the context of peer review recommendations. 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 are encouraged to apply as principal investigators. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Applicants are encouraged to check the website, http://dtp.nci.nih.gov/, for additional information. Direct inquiries regarding programmatic issues to: Adaline C. Smith, Ph.D., D.A.B.T. National Cancer Institute Division of Cancer Treatment and Diagnosis Toxicology and Pharmacology Branch 6116 Executive Blvd., Room 5113, MSC 7458 Bethesda, MD 20892-7458 Telephone: (301) 496-8777 FAX: (301) 480-4836 Email: smithad@mail.nih.gov Direct inquiries regarding fiscal matters to: Sara Stone National Cancer Institute Grants Administration Branch 6120 Executive Boulevard, Room 243 Bethesda, MD 20892 Telephone: (301) 496-9927 FAX: (301) 496-8601 Email: stones@gab.nci.nih.gov Direct inquiries regarding review matters to: Ms. Toby Friedberg Referral Officer National Cancer Institute 6116 Executive Boulevard, Room 8109, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for overnight/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 LETTER OF INTENT Prospective applicants are asked to submit a letter of intent by the dates listed on the first page of this announcement 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 discuss potential problems or concerns with the applicant as well as estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Adaline C. Smith at the address listed under INQUIRIES. APPLICATION PROCEDURES 1. SPECIFIC INSTRUCTIONS FOR PREPARING THE COMBINED R21/R33 PHASED INNOVATION AWARD APPLICATION: Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and prepared according to the instructions provided unless specified otherwise within this SECTION. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: grantsinfo@nih.gov. For applicants with internet access, the 398 kit may be found at: http://grants.nih.gov/grants/forms.htm. R21/R33 applications must include the specific aims and clear measurable goals (milestones) that would demonstrate feasibility and justify transition to the R33 phase. Applications must include a specific section labeled Milestones following the Research Plan of the R21 phase. Milestones should be well described, quantifiable and scientifically justified and not be simply a restatement of the specific aims. It should be clear how the specific aims of the R33 continue and expand the R21 study. A discussion of the milestones relative to the progress of the R21 phase, as well as the implications of successful completion of the milestones for the R33 phase, should be included. See Research Plan, item d, listed below for a further discussion of milestones. R21/R33 combined applications should be submitted as one application with one Face Page. Although it is submitted as a single application, it should be clearly organized into two phases. To accomplish a clear distinction between the two phases, applicants are directed to complete Sections a-d of the Research Plan twice: one write-up of Sections a-d and milestones for the R21 phase and Sections a-d again for the R33 phase. The Form 398 Table of Contents should be modified to show Sections a-d for each phase as well as the milestones. There is a page limit of 25 pages for the composite a-d text. (i.e., Section a-d and milestones for the R21 and Section a-d for the R33 phase must be contained within the 25 page limit.) In preparing the R21/R33 application, investigators should consider the fact that applications will be assigned a single priority score. In addition, as discussed in the REVIEW CONSIDERATIONS section, the initial review panel has the option of recommending only the R21 phase for support. However, an application with an R33 Phase that is so deficient in merit that it is not recommended for support will reflect upon the judgment of the applicant. For these reasons, the clarity and completeness of the R21/R33 application with regard to specific goals and feasibility milestones for each phase are critical. The presentation of milestones that are not sufficiently scientifically rigorous to be valid for assessing progress in the R21 phase will reflect upon the scientific judgment of the applicant. 1. Face Page of the application: Item 2. Check the box marked YES and type the number and title of this PA. Also, indicate that the application is submitted as an R21/R33. Item 7a, DIRECT COSTS REQUESTED FOR INITIAL PERIOD OF SUPPORT: For the R21 phase of the combined R21/R33 application, direct costs are limited to a maximum of $100,000 per year for up to two years and the award may not be used to supplement an ongoing project. The requested budgets can exceed this cap to accommodate F&A costs to subcontracts to the project. Insert the first year of support in item 7a. Item 8a, DIRECT COSTS REQUESTED FOR PROPOSED PERIOD OF SUPPORT: For the R21 phase of the combined R21/R33 application, direct costs requested for the proposed period may not exceed $200,000 for two years of support. The statement in item 7a above pertaining to subcontract costs also applies here. Insert sum of all years of requested support in item 8a. 2. Page 2 - Description: As part of the description, identify concisely the technology or assay methodology to be developed, its innovative nature, its relationship to presently available capabilities, and its expected impact on toxicology approaches. 3. Budget: The application should provide a detailed budget for Initial Budget Period (form page 4), for each of the initial years of the R21 and R33 phases as well as a budget for the entire proposed period of support (form page 5) with R21 and R33 periods listed separately. All budgets should include a written justification for each item requested. 4. Research Plan (Page 15 in PHS 398 Instructions) Item a., Specific Aims. The applicants must present specific aims that the applicant considers to be scientifically appropriate for the relevant phases of the project. The instructions in the PHS 398 booklet for this section of research grant applications suggest that the applicant state the hypotheses to be tested. Since the goal of this PA is to develop new methods for toxicological analysis, hypothesis testing per se may not be the driving force in developing such a proposal and, therefore, may not be applicable. Item b: Background and significance Elaborate on the innovative nature of the proposed research. Clarify how the assay or technology development proposed in this project is a significant improvement over existing approaches. Explain the potential of the proposed technology for having a broad impact on cancer research and toxicological evaluations. Clearly identify how the project, if successful, would result in new capabilities for toxicology analysis, the immediacy of the opportunity, and how the proposed assays would differ from existing approaches. Item c., Preliminary studies/Progress report The R21 phase should provide current thinking or evidence in the field to substantiate feasibility of the R21 phase. While preliminary data are not required for the R21 phase, easily understandable data which provide relevant information to aid review could be included when available. The R33 phase need not repeat information already provided in the R21 phase. Applicants are encouraged to include all information required for adequate review evaluation. However, in the event that assays and technology are not yet patent protected and the applicant does not wish to include complete details, the application should at a minimum provide a demonstration (results) of the capabilities of the proposed approach. Item d., Research Design and Methods Instructions in the PHS 398 booklet should be followed. In addition, for the R21 phase only, the following information must be included as a final section of Item d: Applications must include a specific section labeled Milestones following the Research Design and Methods of the R21 phase. Milestones should be well described, quantifiable, and scientifically justified and not be simply a restatement of the specific aims. A discussion of the milestones relative to the success of the R21 phase, as well as implications of successful completion of the milestones for the R33 phase, and the page number of the milestones section should be listed. This section should be listed in the Table of Contents. Applications lacking this information, as determined by program staff, will be returned to the applicant without review. Completion of the R21 milestones will elicit an expedited review by NCI program staff that will determine whether or not the R33 should be awarded. The release of R33 funds will be based on successful completion of milestones, program priorities, and on availability of funds. Expedited review may result in additional negotiations of award. 2. SPECIFIC INSTRUCTIONS FOR SUBMISSION OF THE R21 APPLICATION WHEN SUBMITTED WITHOUT THE R33 PHASE: Applications for R21 grants are to be submitted on the grant application form PHS 398 (rev. 4/98) and prepared according to instructions provided for R21 applications in the previous section except that milestones and discussion of the implication of the milestones to an R33 phase are not required. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, 6701 Rockledge Dr. MSC 7910, Bethesda, MD 20892-7910, telephone: 301/710-0267, email: grantsinfo@nih.gov. For applicants with internet access, the 398 kit may be found at: http://grants.nih.gov/grants/forms.htm. 1. Face page of the application: Item 2. Check the box marked "YES" and type the number of this PA. Also indicate that the application is for an R21. 3. SPECIFIC INSTRUCTIONS FOR PREPARATION OF THE R33 APPLICATION WHEN SUBMITTED WITHOUT THE R21 PHASE. Applications for R33 grants are to be submitted on the grant application for PHS 398 (rev. 4/98) and prepared according to the instructions provided unless specified otherwise within items 1-5 below. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, 6701 Rockledge Dr. MSC 7910, Bethesda, MD 20892-7910, telephone: 301/710-0267, email: grantsinfo@nih.gov. For applicants with internet access, the 398 kit may be found at: http://grants.nih.gov/grants/forms.htm. 1. Face page of the application: Item 2. Check the box marked "YES" and type the title and number of this PA. Also, indicate that the application is for an R33. 2. Description: As part of the description, identify concisely the technology or assay methodology to be developed, its innovative nature, its relationship to presently available capabilities, and its expected impact on toxicology approaches. 3. Budget: The application should provide a detailed budget for the Initial Budget Period (form page 4) as well as a budget for the entire proposed period of support (form page 5). Budget should include a written justification of all items requested. 4. Research Plan: Item a, Specific Aims: Instructions in the PHS 398 booklet suggest that the applicant state the hypothesis to be tested. Since the goal of this PA is to develop new methods for toxicolgical analysis, hypothesis testing per se may not be the driving force in developing such a proposal and therefore, may not be applicable. Item b, Preliminary studies/Progress Report: R33 applications should clearly state how feasibility for the project has already been demonstrated. It would be expected that this demonstration would include significant data. This section must document that progress has been achieved which is essentially equivalent to that expected from an R21 grant. The application must clearly describe how the project is ready for scale up to an expanded development stage. FOR ALL APPLICATIONS A signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided photocopies, should be submitted in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) To expedite the review process, at the time of submission, send two additional copies of the application to: Ms. Toby Friedberg Referral Officer National Cancer Institute 6116 Executive Boulevard, Room 8109, MSC 8329 Bethesda, MD 20892-8329 Rockville, MD 20852 (for overnight/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Applications must be received by the receipt dates listed at the beginning of this PA. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the CSR for completeness and by NCI program staff for adherence to the guidelines. Applications not adhering to application instructions described above and those applications that are incomplete as determined by CSR or by NCI program staff will be returned to the applicant without review. Applications that are complete and adhere to the guidelines of this PA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NCI, Division of Extramural Activities 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, generally the top half of the applications, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. Within this framework, the specific goals of the PA are the discovery and validation of new and innovative assays which predict specific toxicities of potential cancer drugs. Assays developed under this PA would be expected to be effective for a quick and cost effective determination of toxicity of specific compounds and, importantly, to reduce the number of animals required. 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 for development of a valuable assay. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? What may be the anticipated societal benefit of the proposed activity? Will the proposed toxicology methodology have a competitive advantage over existing toxicology procedures? 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? What is the time frame for developing the proposed technologies and suitability of this time frame for meeting the scientific community"s needs? What are the throughput and cost effectiveness of the proposed toxicology assays? 3. Milestones. How appropriate are the proposed milestones against which to evaluate the demonstration of feasibility for transition to the R33 development phase? 4. Innovation. Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 5. 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 including consultants and collaborators (if any)? 6. Environment. 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 sufficient access to resources (equipment, facilities, etc.)? Is there evidence of institutional support? Additional Considerations For the R21/R33 Application, the initial review group will evaluate the specific goals for each phase and the feasibility milestones that would justify expansion to the R33 phase. A single priority score will be assigned to each scored application. As with any grant application, the initial review group has the option of recommending support for a shorter duration than that requested by the applicant, and basing the final merit rating on the recommended portion of the application. For the R21/R33 application, this may result in a recommendation that only the R21 phase be supported, based on concerns related to the application"s specific goals and the feasibility milestones justifying expansion to the R33 phase. Deletion of the R33 phase by the review panel or presentation of inadequate milestones in the application may affect the merit rating of the application. The initial review group will also examine: the appropriateness of the proposed project budget and duration, the adequacy of plans to include both genders and minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects, the provisions for the protection of human and animal subjects, and the safety of the research environment. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The quality of the proposed project as determined by peer review, availability of funds, and program priority will be considered in making final funding decisions. SCHEDULE Letter of Intent Receipt Dates: December 7, 2000 and October 10, 2001 Application Receipt Dates: January 11, 2001 and November 14, 2001 NCAB Review Dates: May 2001 and May 2002 Earliest Anticipated Award Date: July 1, 2001 and July 1, 2002 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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 the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an internet site. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA, Innovative Toxicology Models for Drug Evaluation, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.395. 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 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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