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INNOVATIVE TOXICOLOGY MODELS FOR DRUG EVALUATION: SBIR/STTR INITIATIVE Release Date: October 25, 2000 PA NUMBER: PAR-01-004 National Cancer Institute National Institute of Diabetes, Digestive and Kidney Diseases National Institute of Drug Abuse Letter of Intent Receipt Dates: December 7, 2000 and October 10, 2001 Application Receipt Dates: January 11, 2001 and November 14, 2001 PURPOSE Recent advances in cancer biology, molecular biology, combinatorial chemistry, and screening technology provide unprecedented opportunities for discovery of new disease therapies. Drug discovery can now be focused on specific molecular or regulatory sites within cells. The National Cancer Institute (NCI) considers exploitation of this knowledge and technology for discovery of new agents to treat or prevent cancer 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 for therapy and screening design efforts to identify agents that effect 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 quickly and effectively evaluate the expected large numbers of new agents. This Program Announcement (PA) encourages the small business community to develop, standardize, and validate 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 therapeutic agents for the treatment and prevention of diseases of interest to the NCI, National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) and the National Institute of Drug Abuse (NIDA). 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. This Program Announcement (PA) must be read in conjunction with the OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH, SMALL BUSINESS INNOVATION RESEARCH (SBIR) and SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS (PHS 2000-2). All of the instructions within the Omnibus Solicitation apply with the following exceptions: o Special receipt dates o Initial review convened by the NCI, Division of Extramural Activities o Additional review considerations For this PA, the Modular Grant format will not be used. This program will utilize the SBIR and STTR mechanisms, but will be run in parallel with a program of identical scientific scope that will utilize Exploratory/Developmental Grants mechanism, PAR-00-003 (see http://grants.nih.gov/grants/guide/pa-files/PAR-00-003.html). 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 therapy diseases of interest to the NCI, NIDDK, and NIDA. For example drug discovery can now be focused on targeting key regulatory pathways or specific macromolecules relevant to cancer and AIDS. Key growth regulatory pathways and mutated genes 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 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 new agents could likewise be exploited to expedite the development and decision process. Investigations focusing on the hazards of potential 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 have 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 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 array analysis. 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 quickly and cheaply determine toxicological profiles of potential 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 by small businesses. For this PA, toxicology data from previous drug development for cancer and AIDS sponsored by NCI may be made available to awardees. For additional informational contact Dr. Adaline C. Smith at the address listed under INQUIRIES. The overall objective of this PA is to provide a flexible funding mechanism with regard to budgets and time of funding for small businesses to support the research activities required to develop and validate innovative toxicology assays. MECHANISM OF SUPPORT Support for this PA is through the SBIR and STTR mechanisms which are set- aside programs. This PA is a one-time announcement which may be reissued. Responsibility for the planning, direction and execution of the proposed project will be solely that of the applicant. Awards will be administered under NIH grants policy stated in the NIH Grants Policy Statement, NIH publication 99-8 October 1998. 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 the SBIR/STTR FAST-TRACK option as described in the OMNIBUS SOLICITATION (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 application must be a logical extension of the Phase I research. Information on the FAST-TRACK process and the OMNIBUS SOLICITATION are available at: http://grants.nih.gov/grants/funding/sbirsttr1/index.htm ELIGIBILITY REQUIREMENTS Eligibility requirements are described in the OMNIBUS SOLICITATION for SBIR/STTR grant applications. Any small business, independently owned by United States citizens or permanent resident aliens, and located in the United States may apply. The small business 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 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. 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 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 Robert Star, M.D. Senior Scientific Advisor National Institute of Diabetes, Digestive and Kidney Diseases Building 31, Room 9A35 31 Center Drive MSC 2560 Bethesda, MD 20892-2560 Telephone: (301) 594-7715 FAX: (301) 496-2830 Email: robert_star@nih.gov David J. McCann, Ph.D. Chief, Medications Discovery & Toxicology Branch National Institute on Drug Abuse Division of Treatment Research & Development 6001 Executive Boulevard, Room 4123, MSC 9551 Bethesda, MD 20892-9551 Telephone: (301) 443-2999 FAX: (301) 443-2599 Email: dmccann@nih.gov Direct inquiries regarding fiscal matters to: Ms. Kathleen Shino National Cancer Institute Executive Plaza South, Room 243 6120 Executive Blvd, MSC 8635 Bethesda, MD 20892-7150 Telephone: (301) 496-8635 FAX: (301) 496-8601 Email: shinok@gab.nci.nih.gov Direct inquiries regarding review matters to: Ms. Toby Friedberg Referral Officer National Cancer Institute Division of Extramural Activities 6116 Executive Boulevard, Room 8109, MSC 8329 Bethesda, MD 20892-8329 Telephone: (301) 496-3428 FAX: (301) 402-0275 Email: tf12w@nih.gov LETTER OF INTENT Prospective applicants are asked to submit, by the dates listed on the first page of this PA, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the PA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and plan the review. NCI policy requires that all applicants requesting greater than $500,000 direct costs in any one year must obtain approval from NCI Program staff prior to submission of the application. If greater that $500,000 per year is requested, this fact must be clearly indicated and approval requested in the letter of intent. The letter of intent is to be sent to Dr. Adaline C. Smith at the address listed under INQUIRIES. APPLICATION PROCEDURES This PA must be read in conjunction with the OMNIBUS SOLICITATION FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS (PHS 2000-2). All instructions within the solicitation apply with the following exceptions: - special receipt dates - initial review convened by the NCI Division of Extramural Activities - additional review considerations Information on the SBIR and STTR programs, OMINBUS SOLICITATION, application forms, and helpful advice on preparation of applications are available at: http://grants.nih.gov/grants/funding/sbir.htm. Hard copies of the SOLICITATIONS, subject to availability, may be obtained from the PHS SBIR/STTR Solicitation Office, telephone (301) 206-9385; FAX (301) 206-9722; email a2y@cu.nih.gov. Applications received in response to this PA are to be prepared as described in the OMNIBUS SOLICITATION (PHS 2000-2). Phase I applications are located in the back pages of the SOLICITATION. All applications and proposals for NIH funding must be self-contained within specified page limitations. Applications will be accepted up to the dates indicated on the first page of this PA. 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 previously reviewed. Applications can be submitted for Phase I or Phase II support, or as a combined Phase I and II (FAST-TRACK). A Phase II application will be accepted only as continuation of a previously funded Phase I grant. The Phase II proposal must be a logical extension of the Phase I research but not necessarily a Phase I project supported in response to this initiative. PHASE I: Demonstration of feasibility of the innovative approach. Research should be proposed to provide sufficient reason to continue the assay development in Phase II. It would be expected that assay methodology would be established. If two years of support are requested, the goals for the first year should be clearly stated and not simply a reiteration of specific aims. Support for the second year will be contingent upon NCI programmatic evaluation to ensure that investigators are accomplishing the goals presented. PHASE II: Development of approach to stage at which the assay can be used for toxicology purposes. Extensive studies designed to validate the approach would be expected. Validation should include analysis of compounds with known organ toxicities. Innovative aspects of the research necessary to complete the projects such as development of new in vivo models which may require “surrogate endpoints” should be clearly described. Goals and milestones for each year of support should be clearly presented. Support for years two to four, if requested, is dependent upon NCI Programmatic review of progress and achievement of the proposed goals. For example, if a goal cannot be achieved such as identification of a known toxicity, the continuation years may not be supported. 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 toxicological assay development, 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 such information 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 an appropriate scientific review group convened by the NIH. Special provisions described in this PA pertaining to Phase I and Phase II also apply to FAST TRACK applications. An additional requirement of the FAST TRACK mechanism is the Product Development Plan. The small business must submit a Product Development Plan (limited to ten 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. However, for this PA, budgets up to $250,000 total costs per year (direct costs, indirect costs, and fixed fee) and time periods up to 2 years for Phase I and $650,000 total costs per year (direct costs, indirect costs, and fixed fee) and up to 4 years for Phase II can be requested. For FAST-TRACK applications the total duration of Phase I plus Phase II cannot exceed 5 years. 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 2a of the Face Page of PHS 6246-3. The applicant small business organization should not 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 3 of PHS 6246-3) and justify this request using “Budget Justification” (form page 5). Phase I SBIR and STTR applications requesting a budget more than one year should follow the following procedures: Photocopy Form Page 3, “Budget for Phase I-Direct Costs Only”, and number it Form Page 3a; Use Form Page 3 for the first year budget and title Form Page 3a “Phase I-2nd year budget”. (This page will not be counted against the 25 page limit.); Provide the appropriate/requested information in the narrative justification (Form Page 4) for years 1 and 2; Indicate on the Phase I Face page Field 6, Dates of Project Period, the dates for the ENTIRE project period; Indicate on the Phase I Face Page in Field 7, the requested Direct Costs and Total Costs for the entire project period; The summary statement will reflect the recommended budget for the -01 and -02 years. 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 one 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 (20817 for express/courier service) To expedite the review process, at the time of submission, send one 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 express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 Applications must be received by the receipt dates listed at the top of the first page of this PA. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by CSR staff for completeness and by NCI program staff for adherence to guidelines. Incomplete applications and applications not adhering to instructions described above will be returned to the applicant without further consideration. Applications that are complete and adhere to the guidelines of this PA will be evaluated for scientific and technical merit and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of this PA by an appropriate peer review group convened by the NCI, Division of Extramural Activities, in accordance with the peer review criteria listed below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate advisory Council of NCI, NIDDK, or NIDA. Review Criteria: Review criteria are described in the NIH Omnibus Solicitation and available on the web at the following URL address: http://grants.nih.gov/grants/funding/sbirsttr1/index.htm 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 validation of new and innovative assays which predict specific toxicities of potential 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 decrease the number of animals required. The reviewers will comment of 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 the criteria will be addressed and considered 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 impact and thus deserve a high priority rating. For example, an investigator may propose to carry out important research that by its nature is not overly innovative but may be essential for development of a valuable assay. 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 the 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/alternative 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 sub-contractors (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 commitment 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: 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; 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; appropriateness of the proposed budget and duration in relation to the proposed research. AWARD CRITERIA Applications will compete for available funds with all other recommended SBIR and STTR applications. 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 commercial success, and availability of funds. A portion of the SBIR/STTR allotment will not be designated for this initiative. 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, grant Program staff’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. 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 sub-populations 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 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, and under funding opportunities at the web site: http://dtp.nci.nih.gov 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 Nos. 93.395, 93.847, 93.848, and 93.849. 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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