PA-01-020: MOLECULAR AND CELLULAR BIOLOGY OF METASTATIC TUMOR CELLS

Department of Health
and Human Services (HHS)

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MOLECULAR AND CELLULAR BIOLOGY OF METASTATIC TUMOR CELLS Release Date: November 21, 2000 PA NUMBER: PA-01-020 National Cancer Institute National Institute of Diabetes and Digestive and Kidney Diseases THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA. This Program Announcement (PA) replaces PA-98-029, which was published in NIH Guide Feb 27, 1998. PURPOSE The National Cancer Institute (NCI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invite exploratory/developmental grant applications to study the molecular and cellular biology of metastatic tumor cells. This special initiative is designed to promote collaborations and facilitate scientific interchange between investigators, one with experience in the biology of metastasis and the other in a more basic scientific discipline such as molecular or cellular biology, or biochemistry. Therefore, prospective Principal Investigators need to identify a research collaborator. This PA will expire on October 2, 2002, unless reissued. NIH Grants policies apply to these awards. RESEARCH OBJECTIVES The goal of this initiative is to provide funds for preliminary research projects that will form the basis of future R01 applications to investigate metastasis. The intent is to (1) foster collaborative research between investigators with basic molecular and cellular biological and biochemical research experience, and those with experience in metastasis research, and (2) increase the number of laboratories and investigators addressing issues of metastasis. The scope of the research may encompass the application of any aspect of molecular and cellular biology and biochemistry to the investigation of metastasis biology. Bone is a major site of metastasis for many tumors, particularly hormone responsive tumors such as prostate and breast. NCI and NIDDK are interested in fostering collaborations among bone endocrinologists and cancer researchers to exploit the implications of new understanding of hormonal regulation of bone cells and matrix for inhibiting metastasis to bone. Applications should be for preliminary data gathering or pilot feasibility studies, and should be founded on the combined research experience of the Principal Investigator and his/her collaborator. The application should specifically address how the application meets the intent of the initiative, e.g., the development of a new collaboration between an investigator with basic molecular and cellular biological and biochemical research experience and one with experience in metastasis research. Furthermore, the research collaborator should address how the proposed research will relate to and integrate with other ongoing research in his/her laboratory. Just as the initiative is intended to foster a research collaboration, the application itself should clearly be the product of in-depth discussions and input from both the research collaborator and the Principal Investigator. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) exploratory/development research grant (R21). Applicants will be responsible for the planning, direction, and execution of the proposed project. Awards will be administered under NIH grants policy as stated in the NIH Grants Policy Statement, NIH Publication No. 99-8, October 1998. The Exploratory/Developmental Research Grants program (R21) provides limited funds for short-term research projects. These grants provide an opportunity for initiating studies that may be preliminary in nature. Research investigators in relevant fields are invited to apply for these grants in order to develop preliminary data that could form the basis of future research project grant (R01) applications. The direct costs per year for each application funded by the NCI must not exceed $75,000. The total project period for an application funded by the NCI in response to this PA may not exceed two years and is not renewable. The Principal Investigator must be accountable to the applicant organization officials for the proper conduct of the project. The research collaborator must be named and their time and effort should be listed on the budget page. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm. 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. Direct inquiries regarding programmatic issues to: Suresh Mohla, Ph.D. Chief, Tumor Biology and Metastasis Branch Division of Cancer Biology National Cancer Institute EPN, Suite 5000 Bethesda, MD 20892 Telephone: (301) 435-1878 FAX: (301) 480-0864 Email: sm82e@nih.gov Direct inquiries regarding fiscal matters to: Mr. Brian Albertini Grants Management Specialist National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7239 Email: albertib@gab.nci.nih.gov Direct inquiries regarding programmatic issues for NIDDK to: Ronald Margolis, Ph.D. Senior Advisor, Molecular Endocrinology Division of Diabetes, Endocrinology, and Metabolism NIDDK 6707 Democracy Boulevard, Rm. 6107 MSC 5460 Bethesda, MD 20892-5460 Telephone: (301) 594-8819 FAX: 301-435-6047 E-mail: rm76f@nih.gov Direct inquiries regarding fiscal matters for NIDDK to: Cheryl Chick Division of Extramural Activities NIDDK 6707 Democracy Boulevard, Rm. 606 MSC 5460 Bethesda, MD 20892-5460 Telephone: (301) 594-8825 FAX: 301-480-3504 E-mail: ChickC@extra.niddk.nih.gov APPLICATION PROCEDURES The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in- time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. Applications will be accepted at the standard application deadlines (February 1, June 1 and October 1) as indicated in the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: grantsinfo@nih.gov. For those applicants with internet access, the 398 kit may be found at: http://grants.nih.gov/grants/forms.htm. Applicants are strongly encouraged to call the program contacts listed in INQUIRIES below with any questions regarding the adherence to the guidelines of their proposed project to the goals of this PA. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $75,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period. Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page (see http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages). At the top of the page, enter the total direct costs requested for each year. This is not a form page. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is domestic or foreign. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm. - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations. o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Applications not conforming to these guidelines will be considered unresponsive to this PA and will be returned without further review. The title and number of the PA must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the checklist, and five signed, exact, single-sided photocopies, 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria The five criteria to be used in the evaluation of grant applications are listed below. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? The initial review group will also examine: the appropriateness of 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 approved applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. The following additional factors will be considered for applications assigned to the NCI: --In order to increase the number of laboratories and investigators with potential for a long-term commitment to metastasis research, preference in funding will be given to those investigators that are early in their research careers --The extent to which the proposed research develops collaborations that address the purpose of the initiative --How the proposed research relates to and integrates with other ongoing research in the research collaborator"s laboratory Applications will compete for available funds with all other recommended applications assigned to that IC. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. 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, MOLECULAR AND CELLULAR BIOLOGY OF METASTAIC CELLS, is related to 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. 93.396, Cancer Biology, and No. 93.847 for the Division of Diabetes, Endocrinology, and Metabolic Diseases in NIDDK. Awards are made under authorization of the Sections 301 and 405 of the Public Health Service Act as amended ( 42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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