COMMUNITY-BASED PREVENTION AND INTERVENTION RESEARCH Release Date: September 2, 1999 RFA: ES-99-012 National Institute of Environmental Health Sciences Letter of Intent Receipt Date: October 19, 1999 Application Receipt Date: December 13, 1999 THIS RFA 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 RFA. PURPOSE The purpose of awards in this program is to develop community-based public health research approaches to diseases and health conditions having an environmentally related etiology and determine the impact of these methods. Moreover, awards are intended to stimulate further advances in the design and implementation of prevention and intervention methods that are appropriately applied to environmental health. 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 Request for Applications (RFA), Community-based Prevention and Intervention Research, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000 ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed 5 years. Competitive continuation applications from existing grantees in the NIEHS Community-based Prevention and Intervention Research Program in their fourth year of support will be accepted for consideration under this RFA. Such applications must follow PHS 398 guidelines for competitive renewal, including a progress report. Such applicants are strongly encouraged to contact Program Staff listed under INQUIRIES for additional guidance. The anticipated award date is July 1, 2000. It is anticipated that the maximum award will be $300,000 direct costs per year for each grant. 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 FUNDS AVAILABLE The NIEHS intends to commit approximately $2,500,000 in FY 2000 to fund approximately five new and/or competitive continuation grants in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $300,000 per year. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NIEHS provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. RESEARCH OBJECTIVES Background The mission of the NIEHS is to define: how environmental exposures affect our health; how individuals differ in their susceptibility to these effects; and how these susceptibilities change with time. To help reduce the burden of environmentally associated diseases and health conditions, the NIEHS must: (1) provide the scientific basis and foundation that is necessary for understanding the impact of the environment on human health; (2) translate this information into prevention and intervention strategies; and (3) communicate this information to the public. The current initiative spans all three of these elements within the missions of the NIEHS. Environmental health policy is only as good as the scientific foundation upon which it rests. Recent advances are enabling scientists to develop more detailed and meaningful insights into the effects of environmental agents on basic cellular processes. This knowledge in turn can be used to cultivate intervention schemes based on an enhanced understanding of molecular mechanisms. In 1992 the NIEHS issued an RFA to develop interventions at the molecular level for diseases with an environmental etiology. That RFA focused on generation and use of molecular biomarkers to assess the effectiveness of intervention strategies. In 1996 the NIEHS released an RFA to develop novel culturally relevant prevention/intervention activities in economically disadvantaged and/or underserved populations adversely impacted by an environmental contaminant. Environmental health concerns addressed by awards made in response to this RFA included programs that address: exposure to agents that exacerbate asthma; reducing agricultural pesticide exposures and reduction of exposure to lead. The challenge remains to continue to develop community-based prevention/intervention strategies that address other environmentally influenced health outcomes in medically underserved communities, e.g., low birth weight in infants, autoimmune diseases, diabetes and cardiovascular diseases. An understanding of the environmental components and basic biology of disorders can lead to prevention and intervention strategies to circumvent adverse health effects. Such strategies can be classified as primary, secondary, or tertiary prevention. Traditionally, most approaches have focused on primary prevention techniques aimed at intervening before disease arises, such as eliminating or reducing environmental exposures. As our understanding of the molecular and cellular basis of environmentally associated diseases increases, secondary prevention and intervention techniques can be developed to diagnose and treat people exposed to an environmental contaminant. These molecular intervention techniques, such as early detection screening, rely on manipulation of underlying biological mechanisms, e.g., activation/inactivation of particular genes, enzymes, or receptors. These methods may be especially useful in dealing with environmental exposures that are ubiquitous or difficult to eliminate. Tertiary prevention measures seek to limit injury and disability in people already affected by a specific disease process. Prevention and intervention schemes must also take into account the social and cultural lifestyle and behavioral factors that contribute to environmentally associated disorders. It is part of the responsibility of the NIEHS to provide the scientific underpinning that can delineate the contribution of societal and cultural behaviors in development of these disorders. The cultural diversity inherent within various racial/ethnic groups has generally been overlooked by investigators conducting prevention research. Thus, there is a critical need to address diverse, culturally relevant contexts and disease etiologies in environmental health. The present RFA seeks to implement culturally relevant prevention/intervention activities in economically disadvantaged and/or underserved populations adversely impacted by an environmental contaminant. Research efforts to identify the sources and effects of hazardous environmental exposures among underserved populations have been insufficient. Little is known about the types of environmental agents to which members of such groups are exposed, both at home and at work. Members of economically disadvantaged and/or underserved populations suffer disproportionate levels of morbidity and mortality. Additionally, they are most often the populations with the highest degree of exposure to environmental agents and are frequently the populations with the least information available as to the health consequences of such exposure. Factors such as malnutrition, health status, and socioeconomic status, in combination with behaviors such as smoking, alcohol consumption, and drug use may significantly influence the dose response, metabolism, and health effects of hazardous substances. Geographic location may also play a role in determining the degree and effect of environmental exposure among socioeconomically disadvantaged populations. For example, inner city residents often live in homes with high lead levels and are exposed to higher levels of air pollution. Toxic waste sites, nuclear facilities, and chemical plants are often located in rural areas. More effort must be devoted to identifying disadvantaged populations having high levels of exposure to environmental hazards and to generating prevention and intervention strategies to mitigate the health effects of these hazards. The current RFA is intended not only to foster additional refinement of intervention methods but also to strengthen the participation of affected communities in this effort. Given the complexity and magnitude of environmental health problems, research endeavors aimed at improving our knowledge of and ability to resolve these issues can benefit from establishing collaborative relationships with the communities experiencing these problems. Such community research partnerships have benefits for both the researcher and the community. These partnerships can, for example, facilitate the definition of important environmental issues and concerns, the development of measurement instruments that are culturally appropriate, and the establishment of trust that will enrich the value of data collected. This scheme emphasizes the involvement of community members throughout the research process, from development of research questions to interpretation, application, and dissemination of results. Only through realization of this final leg of the NIEHS mission, i.e., communication and partnership formation, can we ensure that research findings reach and are made relevant to affected individuals and communities. Objectives and Scope This RFA will support research activities that develop and implement improved prevention and intervention strategies related to environmental health that are designed to include community-based, culturally appropriate approaches applicable to underserved populations. Community-based prevention/intervention research seeks to expand our knowledge and understanding of the potential causes and remedies of environmentally related disorders, while at the same time enhancing the capacity of communities to participate in the processes that shape research approaches and intervention strategies. Community-based research is thus more than just a community placed outreach activity. These research projects are community driven and responsive so as to maximize the potential for change in knowledge, attitudes, and behavior. They are conducted in a manner that reinforces collaboration between community members and research institutions. Relevant results from these projects are disseminated to the community in clear, useful terms. Moreover, these studies are designed to be culturally appropriate, i.e., due consideration is given to the social, economic, and cultural conditions that influence health status. Identifying and incorporating unique cultural factors into intervention strategies may result in increased acceptability, use, and adherence. Each application should develop a comprehensive, strategic plan with time schedules and milestones to address all key aspects. This plan should include: o Identification of target community. Population(s) should be clearly identified, community boundaries described, and known environmental health hazards delineated. o Community collaboration. How will communication and regular exchange of information and ideas between community members and institutional researchers be initiated and enhanced? How are productive relationships with local representatives established and maintained? How are local organizations and leaders recruited? What are the mechanisms for communities to identify their environmental health needs? How will activities be designed to meet these needs? How will findings be disseminated within the community? o Research program definition and implementation. A variety of research designs may be proposed. Primary, secondary, or tertiary prevention strategies may be included. Interventions should be based on appropriate behavioral and scientific theories. They should also be built on the results of previous methods shown to be efficacious in changing risk factors related to knowledge, attitudes, and behaviors. Interventions should use multiple, culturally sensitive, community-based approaches and be adapted to the special needs of underserved populations. o Evaluation. Both outcome and process evaluations should take place. Only projects having well developed, comprehensive evaluation plans will be supported. The application must include detailed descriptions of process and outcome evaluation, specify the measures and instruments for data collection, and indicate a time frame for conducting all evaluation activities. Experimental design is not restricted by this RFA. Applicants should develop their own independent design and provide appropriate justification. Designs should focus on an integrated approach employing various culturally appropriate factors that have been previously shown to be effective. It is important that the study population be clearly identified and that community involvement in developing the design be demonstrated. An experimental design with a defined hypothesis is the preferred approach. A randomized design, comparing specially constructed interventions against usual and customary conditions, would be one appropriate study design to test intervention models. Other designs may also be considered responsive. Elements that may be considered in assembling a research design include sampling procedures, instrumentation and measurement, data collection, quality control, recruitment, retention, tracking and follow up, and data analysis. State of the art econometric techniques for measuring cost effectiveness of prevention efforts may also be included. Applicants are encouraged to test and compare multiple innovative strategies and to assess their relative effectiveness. Community-based Research Community-based research seeks to enhance the capacity of communities to participate in the processes that shape research approaches and intervention strategies. Active cooperation and participation of organizations within the community(ies) that is (are) the focus of the study are essential components of the research. Hence, applicants must describe an existing or proposed involvement with one or more community-based organizations in an area having an underserved population adversely impacted by an environmental contaminant. This connection is essential to the development of community-based approaches and should also enhance the potential for long term impact of the project. Community input is most meaningful and best utilized if it is built into the research process from the outset. Community representatives should be given a voice in choosing research topics, developing the application, collecting data, and interpreting results. Thus, projects should be community-driven and community-responsive. Research efforts should reinforce the collaborations between communities, health care providers and scientists. Results generated by the research should be disseminated to community members in useful terms. This will mandate that all facets of the project design be culturally appropriate. Involvement of an Historically Black College or University, Hispanic College, or Tribal College and/or recruitment of staff from the community may be appropriate. However, such efforts will not substitute for direct involvement of a community-based organization. Applications lacking an existing or proposed link to a community-based organization will be considered to be nonresponsive to this RFA. The NIEHS has been active in developing pioneering efforts with translational research programs. Innovative programs linking environmental health scientists with health care providers, community members, educators and schools are making tremendous impacts on environmental health awareness in medically underserved communities across the nation. The NIEHS has supported the development of programs that are at the forefront of community input and participation with regard to environmental health concerns. Benefits of community-based research include: o The formation of bridges between scientists and communities that allow both to gain in knowledge and experience. o Better definition of a particular environmental health concern. o Assistance in development of culturally appropriate measurement instruments, thus making projects more effective and efficient. o Establishment of a level of trust that will enhance both the quantity as well as the quality of data collected. o The community gains more knowledge about environmental health problems; and has a role in addressing those problems. o Relationships are built that can have a longer term impact or influence on those problems. Principles of community-based research include: o Community-based research seeks to enhance the capacity of communities to participate in the processes that shape research approaches and intervention strategies. o Active cooperation and participation. o Community members have a voice in choosing research topics, developing projects, collecting data, and interpreting results. o Projects are community-driven and -responsive. o Research efforts reinforce collaboration. o Results are disseminated to the community in useful terms. o Designed to be culturally appropriate. SPECIAL REQUIREMENTS Annual meetings, to be held in Research Triangle Park, NC, are planned for the exchange of information among investigators. Applicants must budget travel costs associated with these meetings in their applications. In addition, since these projects are community-based and embrace both research demonstration and dissemination, applicants are expected to maximize opportunities for information exchange between institutional researchers and community members. As part of this program, applicants must generate a report that describes community input, program implementation, and relevant findings. This report must be produced at least annually and distributed among community members in such a way that it can be easily comprehended by the public. Applicants must budget for production and dissemination of such reports. This requirement is intended to establish a minimal level of communication among project participants; additional, more frequent dissemination efforts may be appropriate. Relationship to Environmental Justice Activities conducted under this RFA should be consistent with Federal Executive Order No. 12898 entitled, Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations. To the extent practicable and permitted by law, grantees shall make achieving environmental justice part of their project's mission by identifying and addressing, as appropriate, disproportionately high and adverse human health effects of environmental contaminants on minority and low income populations. The current RFA builds upon the framework established by the separate NIEHS grant program entitled "Environmental Justice: Partnerships for Communication." That program, initiated in 1993, supports outreach, training, and education efforts that will become the catalyst for reducing exposure to environmental pollutants in underserved populations. Its main objective is to establish methods for linking members of a community, who are directly affected by adverse environmental conditions, with environmental health researchers and health care providers. This endeavor will help to ensure that the community is aware of basic environmental health concepts and that they have a role in defining problems and shaping approaches to their solution. The present RFA differs from the Environmental Justice grant program in that the former is a scientific research demonstration and dissemination project, whereas the latter is an education project. Thus, this RFA is intended to support specific, rigorous, scientific research projects that develop and implement community-based, culturally appropriate prevention/intervention strategies in underserved communities. The Environmental Justice program supports education projects that enhance the flow of information and communication among scientists, health care providers, and community members. Although these programs are complementary, it is important to differentiate the substantial research orientation of this RFA from the educational goal of the Environmental Justice program. 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 was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-100.html 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 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 these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by October 19, 1999, 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 RFA 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 NIEHS staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: David P. Brown, M.P.H. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-24 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-4964 Fax: (919) 541-2503 Email: brown4@niehs.nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/435-0714, Email: GrantsInfo@nih.gov. 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. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions. 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: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) 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 key 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 key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. 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. o 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. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. The RFA label and line 2 of the application should both indicate the RFA number. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and three signed, 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) At the time of submission, two additional copies of the application must be sent to: David P. Brown, M.P.H. Division of Extramural Research and Training National Institute of Environmental Health Sciences P.O. Box 12233, MD EC-24 111 T.W. Alexander Drive Research Triangle Park, NC 27709 Telephone: (919) 541-4964 Fax: (919) 541-2503 Email: brown4@niehs.nih.gov Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NIEHS staff. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIEHS 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 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 Advisory Environmental Health Sciences Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application 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 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 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? In addition to the above criteria all applications will also be reviewed with respect to the following: o Extent of community sanction/liaison. Rationale for selection of the targeted population and documentation of environmental health needs and risk factors. Evidence of access to, interaction with, and participation of community members and community leaders in development and conduct of the project. Establishment of collaborative interactions among all project participants. Extent to which the design demonstrates sensitivity to cultural and socioeconomic factors in the community. o Demonstration of effective communication channels between researchers and community members. Plans for useful and practical dissemination of project activities and findings within the affected community(ies). Active involvement of at least one community based organization is a minimal requirement for responsiveness to this RFA. o Appropriateness of proposed budget and duration in relation to the project's objectives. o Adequacy, appropriateness, feasibility, and comprehensiveness of the evaluation plan, including sufficient allocation of resources. o Feasibility of plans for independently continuing the program. Evidence of continuing commitment on the part of the proposing institution(s). The potential long term impact of the proposed project is especially important. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o 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. o The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. Schedule Letter of Intent Receipt Date: October 19, 1999 Application Receipt Date: December 13, 1999 Peer Review Date: March 2000 Council Review: May 2000 Earliest Anticipated Start Date: July 1, 2000 AWARD CRITERIA Criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Frederick L.Tyson, Ph.D. Chemical Exposures and Molecular Biology Branch National Institute of Environmental Health Sciences P.O. Box 12233, 111 T.W. Alexander Drive, MD EC-21 Research Triangle Park, NC 27709 Telephone: (919) 541-0176 FAX: (919) 316-4606 Email: tyson2@niehs.nih.gov Direct inquiries regarding fiscal matters to: Carolyn B. Winters Grants Management Branch National Institute of Environmental Health Sciences P.O. Box 12233, 111 T.W. Alexander Drive, MD EC-21 Research Triangle Park, NC 27709 Telephone: (919) 541-7823 FAX: (919) 541-2860 Email: winters@niehs.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.113, 93.114, and 93.115. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under 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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