SPECIALIZED CENTERS OF RESEARCH (SCOR) IN NEUROBIOLOGY OF SLEEP AND SLEEP APNEA AND AIRWAY BIOLOGY AND PATHOGENESIS OF CYSTIC FIBROSIS Release Date: December 11, 2001 RFA: RFA-HL-02-013 National Heart, Lung, and Blood Institute (http://www.nhlbi.nih.gov) Letter of Intent Receipt Date: September 11, 2002 Application Receipt Date: October 11, 2002 PURPOSE The primary objective of the Specialized Centers of Research (SCOR) programs is to foster multidisciplinary basic and clinical research enabling basic science findings to be more rapidly applied to clinical problems. The basic and clinical research to be supported through this RFA will be related to one of the above two categories. It is expected that results from these SCOR grants will have an impact on the prevention, diagnosis, and treatment of disorders of sleep and cystic fibrosis. This is the second and final 5-year solicitation for these two SCOR programs. 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 Request for Applications (RFA), Specialized Centers of Clinical Research, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by for-profit and nonprofit domestic institutions, public and private, such as universities, colleges, hospitals, and laboratories. Awards will not be made to foreign institutions. However, under exceptional circumstances, a foreign component critical to a project may be included as a part of that project. Women and minority investigators are encouraged to apply. This RFA is intended to support SCOR grants for basic and clinical investigations. Applications that include only basic or only clinical research will not be responsive to this announcement. Each awarded SCOR must consist of three or more projects, all of which are directly related to the SCOR program topic. MECHANISM OF SUPPORT This RFA will use the NHLBI SCOR (P50) grant to support this research program. Applications received in response to the Neurobiology of Sleep and Sleep Apnea and Airway Biology and Pathogenesis of Cystic Fibrosis programs may be either new or renewal applications. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. All current policies and requirements that govern the research grant programs of the NIH will apply to grants awarded under the RFA. Basic and Clinical Research The overall concept of a SCOR program focuses on scientific issues related to diseases and disorders relevant to the mission of the NHLBI. It is essential, therefore, that all applications include both basic and clinical research projects. Interactions between basic and clinical scientists are expected to strengthen the research, enhance transfer of fundamental research findings to the clinical setting, and identify new research directions. Plans for transfer of findings from basic to clinical studies should be described. In order for a project to be considered clinical for the purposes of responsiveness to this RFA, the research must fit the definition of clinical research in the PHS 398 (https://grants.nih.gov/grants/funding/phs398/phs398.html, parts 1 and 2, but not part 3). That is, the research must be either patient-oriented research, or an epidemiologic or behavioral study. For patient-oriented research, this is "research conducted with human subjects (or material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects." To be responsive, clinical investigations may include studies of subjects with the disease of interest as well as normal healthy subjects. In studies involving the use of human specimens, e.g., blood, bronchoalveolar lavage, or biopsy, the investigators must have direct interaction with the subject or patient and relate the research results to the patient status or outcome for this to be considered a clinical project. It is intended that the requirement for investigator interaction with the study participants will eliminate research involving archived tissue. Human biomedical and behavioral studies of etiology, pathogenesis, prevention and prevention strategies, diagnostic approaches, and treatment of diseases, disorders or conditions are also responsive. Small population-based epidemiologic studies, where the research can be completed within 5 years, may also be proposed. However, clinical research projects focused on large epidemiologic studies or Phase III clinical trials will be considered unresponsive to this RFA. In addition, basic research projects must be included that relate to the clinical focus. A SCOR may also contain one or more core units that support the research projects. A core cannot be counted as a clinical project. Applicants should provide a detailed data and safety monitoring plan for the clinical research proposed; the monitoring plan will be considered as part of the peer review of the application. This plan should address informed consent, recruitment, reporting of adverse events, patient safety, oversight of clinical issues in the protocols, storage and analysis of confidential data, and dissemination of any research results. The NIH Policy for Data and Safety Monitoring can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. There may be isolated cases when the Institute may wish to convene a DSMB to oversee the clinical projects in a SCOR program. This will be determined after review and selection of the SCOR centers. Principal Investigator (SCOR Director) and Project Leaders The principal investigator should be an established research scientist with the ability to ensure quality control and the experience to administer both basic and clinical research effectively and integrate all components of the program. A minimum time commitment of 25 percent is required for this individual. The Principal Investigator must be the project leader of one of the component research projects. If this project is not recommended by peer review, the overall SCOR application will not be considered further. If this project is judged by peer review to be of low scientific merit, this will markedly reduce the overall scientific merit ranking assigned to the entire application. Project leaders should have significant research experience and must agree to commit at least 20 percent effort to each project for which they are responsible. Length of SCOR Programs Each NHLBI SCOR program is limited to 10 years of support. Exceptions to this policy will be made only if a thorough evaluation of needs and opportunities, conducted by a committee composed of non-federal experts, determines that there are extraordinarily important reasons to continue a specific SCOR program. Under this policy, a given SCOR grant is awarded for a 5-year project period following an open competition. Only one 5-year competing renewal is permitted, for a total of 10 years of support, unless the SCOR program is recommended for extension. The NHLBI comprehensive evaluation of the Neurobiology of Sleep and Sleep Apnea and Airway Biology and Pathogenesis of Cystic Fibrosis SCOR programs will be conducted during the second project period according to the following timetable: Program Announced: FY 1996 Project Period (First Competition): FY 1998 through FY 2003 Program Reannounced: FY 2002 Project Period (Second Competition): FY 2003 through FY 2008 Letter to SCOR Directors Regarding SCOR Evaluation Plans: FY 2005 (mid-way through year 02 of 2nd project period) SCOR Evaluation Meeting: FY 2005 (late in year 02 of 2nd project period) The NHLBI does not limit the number of SCOR applications in a given SCOR program from one institution nor does it limit the number of applications in the two SCOR programs described in this announcement from one institution. However, there must be a different SCOR principal investigator for each application and each application must be self-contained and independent of the other(s). This does not preclude cooperation planned or possible among participants of SCORs after awards are made. Scientific overlap among applications will not be accepted. If more than one application in a given program is envisioned from an institution, the institution is encouraged to discuss its plans with the NHLBI SCOR program administrator. FUNDS AVAILABLE For new applications, the applicants may request up to $1,420,000 direct costs, not including facilities and administrative costs for collaborating institutions, in the first year, and for renewal applications, the applicants may request a ten (10) percent increase over the last year of the preceding project period or a total of $1,420,000, whichever is less. An increase of no more than 3 percent may be requested in each additional year. Award of grants pursuant to this RFA is contingent upon availability of funds for this purpose. It is estimated that a total of $11,600,000 will be available for the first year of support for the two programs and it is anticipated a total of up to seven awards will be made. Equipment is included in the budget limitation. However, requests for expensive special equipment that cause an application to exceed this limit may be permitted on a case-by-case basis following staff consultation. Such equipment requests require in-depth justification. Final decisions will depend on the nature of the justification and the Institute's fiscal situation. Consortium Arrangements If a grant application includes research activities that involve institutions other than the grantee institution, the program is considered a consortium effort. Such applications are permitted, but it is imperative that a consortium application be prepared so that the programmatic, fiscal, and administrative considerations are explained fully. The published policy governing consortia is available in the business offices of institutions that are eligible to receive Federal grants-in-aid. Consult the latest published policy governing consortia before developing the application. For clarification of the policy, contact Mr. Ray Zimmerman, Grants Operations Branch, NHLBI, 301-435-0171. Applicants of SCOR grants should exercise great diligence in preserving the interactions of the participants and the integration of the consortium project(s) with those of the parent institution, because synergism and cohesiveness can be diminished when projects are located outside the group at the parent institution. Indirect costs paid as part of a consortium agreement are excluded from the limit on the amount of direct costs that can be requested. RESEARCH OBJECTIVES Background The SCOR program was initiated within the Division of Lung Diseases in 1971 as a Pulmonary SCOR. Since then, several modifications and changes in program direction have been made and new SCOR programs have been implemented. As a result of a congressional mandate, two new SCOR programs, Cardiopulmonary Disorders During Sleep and Cystic Fibrosis, were announced in 1988, resulting in a total of five awards. In 1991 renewal programs in Cardiopulmonary Disorders of Sleep and Cystic Fibrosis were announced. In FY 1993, a total of four awards were made for centers in Cardiopulmonary Disorders of Sleep and three in Cystic Fibrosis. In response to the new Institute policy that each SCOR program is limited to 10 years of support, unless a programmatic evaluation indicates that further support is warranted, the Division convened an evaluation committee in 1995 to review the SCOR programs in Cardiopulmonary Disorders of Sleep and Cystic Fibrosis. They recommended that new SCOR programs be announced in Neurobiology of Sleep and Sleep Apnea and in Airway Biology and Pathogenesis of Cystic Fibrosis. In fiscal year 1998 three awards were made for centers in Neurobiology of Sleep and Sleep Apnea and four awards in Airway Biology and Pathogenesis of Cystic Fibrosis. This is the reannouncement for these two SCOR programs for the second 5 year period of funding. Justification for announcing a competition in the SCOR programs in Neurobiology of Sleep and Sleep Apnea and Airway Biology and in Pathogenesis of Cystic Fibrosis are based on the recommendations from the SCOR evaluation, on past accomplishments, which have been provided in reports from the Division and the Institute, and on opportunities for new research directions. Funding for these two SCOR programs expires on August 31, 2003. Proposed Research Applications must be addressed to only one of the two categories identified in this announcement to be acceptable for this competition. A SCOR grant is a 5- year program, therefore, an applicant should submit a 5-year plan for all the projects. If a project can be completed in less than 5 years, it should not be included in the application. Examples of research topics of interest for each SCOR program under competition are listed below. These research topics are intended to provide a perspective of the scope of research that would meet the objectives of this program. It is not required that all or any of these topics be included; investigators are encouraged to consider other topics that are relevant to the goals of these programs. Neurobiology of Sleep and Sleep Apnea The objective of this SCOR program is to integrate clinical research on the etiology and pathogenesis of sleep disorders, particularly sleep apnea, with molecular, cellular, and genetic approaches to the study of sleep. Neurobiological mechanisms underlying the relationship of sleep apnea to cardiovascular, pulmonary, hematological, endocrine, immunological, and other health consequences are also of interest. The scope of the program includes repetitive episodes of complete or partial obstruction of the upper airway during sleep (sleep-disordered breathing). The research topics identified below are offered as examples that would be responsive to this announcement. Sleep disordered breathing and snoring have been implicated as risk factors for the development of hypertension, ischemic heart disease, and cerebral infarction. Research is needed to examine the pathophysiologic role of the nervous system in the association of sleep disordered breathing with heart, lung, and blood diseases. Studies are also needed to elucidate neural mechanisms underlying the influence of sleep on cardiovascular, vascular, and immunological function. Since excessive daytime sleepiness is a major clinical consequence of sleep apnea, another important focus is to identify factors that can be quantified with minimally invasive procedures to assess sleep status, the sleep requirements of individuals, and the consequences of excessive daytime sleepiness on normal health and development. The neurobiological basis of impaired daytime performance due to sleep disordered breathing also needs to be elucidated. The development of new therapeutic strategies for the treatment of sleep disordered breathing and associated health consequences, particularly pharmacologic approaches, remains an important goal of this SCOR program. Epidemiologic studies have provided new insights into the risks associated with sleep disordered breathing. Studies are needed to better define the clinical threshold at which sleep disordered breathing presents significant health risks, and determine its predictors and antecedents, particularly in its early phases. Evidence now suggests that the nature of sleep disturbances associated with sleep apnea in children may be different than in adults. Attention should be given to the relationship between pathologic and physiologic abnormalities, gender specific factors, and age. Better objective measures and standardized criteria for sleep apnea, including associated morbidity and mortality also need to be investigated. Recent findings indicate that sleep disordered breathing and several other sleep disorders exhibit patterns of familial aggregation and suspected genetic predisposition. Studies are needed to elucidate the genetic programs regulating normal human sleep and phenotypic variations in the amount, timing, architecture, and electrophysiologic characteristics of sleep. Polymorphisms at multiple loci are likely to be involved, but very few studies have attempted to identify the underlying genetic factors or estimate the role of inheritance in human sleep disorders. Mammalian genes with strong effects on endogenous circadian rhythmicity such as Clock have been identified in various tissues including brain, heart, and lung. Genes encoding receptors and metabolic enzymes for neurotransmitters critically involved in the regulation of sleep (and in functions related to sleep disorders such as breathing and neuroendocrine/immune function) have been cloned and mapped. Some of these genes are polymorphic, but whether these polymorphisms influence sleep/circadian rhythms in human populations, are associated with disorders such as sleep disordered breathing, or contribute to disease development or progression in other physiologic systems needs to be determined. The elucidation of neural pathways and the molecular processes regulating normal sleep and sleep disordered breathing continues to be an area of interest. For example, molecular neurobiologic approaches should be applied to determine what neurons express sleep regulating factors, whether sleep disordered breathing changes the expression of sleep regulating factors, and to elucidate the regulatory signals involved in these events. It is also important to determine how the levels of endogenous sleep regulating compounds vary with the sleep/wake cycle. Studies are needed to investigate the neurobiologic significance of sleep disorders, particularly sleep apnea, in the maintenance of brain functions such as learning, and to characterize its role in neurologic disease processes. Integrating clinical research on sleep apnea with the neurobiology of sleep will advance our understanding of major clinical consequences of sleep apnea, including excessive daytime sleepiness and increased risk of cardiovascular disease. Airway Biology and Pathogenesis of Cystic Fibrosis (CF) The Airway Biology and Pathogenesis of CF SCOR program seeks to develop multidisciplinary collaborations focused on fostering the translation of basic research to clinical applications. Current knowledge of CFTR will be utilized to promote research advances on the pathogenesis of CF, the role of CFTR in airway biology, and the development of new prevention and treatment strategies. Information on how CF begins and progresses in the airway with respect to inflammation and/or infection, and their inter-relationship, is particularly important as is understanding the role of host defense mechanisms and inflammatory mediators in preventing or contributing to pathogenesis. Novel therapeutic approaches directed at controlling these processes need to be developed and tested. Understanding the nature of the vulnerability of CF patients to infection and excessive inflammation is critical for planning therapeutic strategies for CF patients at all stages of disease. Further investigation is essential into the mechanisms generating and controlling the airway surface fluid (ASF), which may be critical to pulmonary homeostasis and lung defense, and how normal and mutant CFTR affect it. Pertinent clinical data relevant to these responses need to be generated. The contribution of the submucosal glands versus the surface epithelium to normal fluid and electrolyte balance and to the pathogenesis of CF needs to be determined. Information on stem or progenitor cells in the airways is critical to our understanding of basic aspects of lung biology and would be helpful for therapeutic approaches. Our knowledge of the biology, structure and function of normal and mutant CFTR remains superficial. The interaction of CFTR with other membrane and cellular proteins needs to be defined, as well as its functional consequences. Factors other than the primary defect in CFTR govern the fate of patients with CF such as environmental factors, the acquisition of certain infections, bacterial gene products, and genetic modifiers of the CF phenotype. These factors need to be identified and characterized. New therapies are needed which correct the primary defect or activate alternative pathways to prevent airway disease. Thus, there is a critical need to translate the new knowledge regarding the pathogenesis of CF and the function of CFTR into new treatment strategies. The development of novel pharmacologic and gene therapies are important, such as the development of agents which correct defective CFTR, enhance expression or activity of CFTR, facilitate trafficking of CFTR to the apical cell membrane, or interfere with bacterial colonization. Barriers to persistent correction of defective CFTR function such as vector-induced inflammatory and immune responses and low efficiency of airway cell transduction should be eliminated. Identification of appropriate lung cell targets for gene transfer such as progenitor, surface and submucosal gland cells is important. Translational research is essential for potential treatment modalities resulting from ongoing pathophysiologic analyses of cytokines, chemoattracants, adhesion molecules and other potential immunotherapies; gene therapy; mucus production and composition; natural peptide antibiotics (e.g., defensins); and alternative ion channels. A better understanding would be helpful of the processes of protein processing and degradation operative in CF airways and pharmacologic interventions to disrupt downstream pathology. As potential sites of therapeutic targets designed to provide alternate pathways for fluid production in CF airways, it would be important to study alternate ion channels, uncover new receptors which control lung function and develop methods of overcoming aberrant processing of mutant CFTR. The molecular and physiologic defects in CF need to be linked with the clinical aspects of CF lung disease. SPECIAL REQUIREMENTS Special features of SCOR grants are: o They provide opportunities for investigators with mutual or complementary interests to engage in multidisciplinary research focusing on a specific respiratory disorder. o Inherent in the SCOR program is a special interaction among the principal investigator, the grantee institution and the Division of Lung Diseases. Funds are specifically allocated in a SCOR grant for investigators from different SCORs to meet and discuss problems of mutual interest and to participate in workshops addressing common research areas. o The Division's SCOR programs undergo periodic evaluations. Requirements of SCOR grants: 1. Research conducted at the individual centers must include both basic and clinical research to ensure that advances in the basic sciences are translated rapidly into clinical applications and that clinical needs will provide a direction for the basic research. Therefore, each SCOR grant application and award must include one or more clinical research project(s) as specified under the section "Basic and Clinical Research." The basic research projects should clearly relate to the disease focus and contribute to elucidation of mechanisms underlying the disease, or to improved diagnosis or management of the disease. 2. Each component project whether basic or clinical requires a well-described clinically relevant hypothesis, preliminary data and a time-table for conducting the proposed investigations. 3. The relationship of each core to the research projects should be described. A core cannot be counted as a clinical project. 4. The principal investigator (SCOR director) should be an established scientist with the ability to ensure quality control and the experience to administer basic and clinical research effectively and integrate all components of the program. A minimum time commitment of 25 percent is required for this individual. The principal investigator must also be the project leader of one of the component research projects. If this project is not recommended by peer review, the overall SCOR application will not be considered further. If this project is judged by peer review to be of low scientific merit, it will markedly reduce the overall scientific merit ranking assigned to the entire application by the review committee. 5. Project leaders should have significant research experience and must agree to commit at least 20 percent effort to each project for which they are responsible. Investigators with minimal research experience, but promising credentials, may participate; however, it is expected that most of the project leaders will be investigators with significant research experience. 6. Each SCOR must have a well-delineated organizational structure and administrative mechanism that foster interactions between investigators, accelerate the pace of research, and ensure a productive research effort. 7. If a project leader transfers to another institution, support for the project will normally not be continued as a consortium. Because of the size and complexity of a SCOR, prospective applicants are urged to consult with the staff of the Division of Lung Diseases early in the preparation of the application (see INQUIRIES Section). To provide opportunity for such interactions, the time frame for implementation of this program includes an ample interval between the release of this RFA, and the receipt date for applications. 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 clinical research projects unless a clear and compelling justification is provided indicating 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. NIH POLICY AND GUIDELINES ON THE 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 and Type 2) 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: https://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. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. 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. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the principal investigator, the names of participating institutions, the identities of other key personnel, 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 subsequent applications, it assists the NHLBI staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to the Chief, Review Branch, listed under Inquiries no later than September 11, 2002. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) available at https://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable format. For further assistance contact GrantsInfo, Telephone 301-710-0267, Email: GrantsInfo@nih.gov. Special instructions are needed for preparing a SCOR application and are available from the program contact listed under Inquiries or at http://www.nhlbi.nih.gov/funding/inits/dldscor.htm. Plans for data safety monitoring must be included for the clinical research proposed. Applicants should describe the organizational structures and procedures they will employ to ensure the safety of participants and the validity and integrity of the data; for a statement of issues and concerns, see NIH Policy for Data and Safety Monitoring, NIH guide to Grants and Contracts, Release Date: June 10, 1998, https://grants.nih.gov/grants/guide/notice-files/not98-084.html. At the time of the award, applicants should be prepared to make adjustments to their procedures based upon NHLBI policy. The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 as well as all five collated sets of Appendix material must be sent to Chief, Review Branch, at the address listed under Inquiries. 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 also 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. Principal investigators should not send supplementary material without first contacting the Scientific Review Administrator (SRA). The SRA will be identified in the letter sent to you indicating that your application has been received. If you do not receive such a letter within three weeks after submitting the application, contact Dr. Deborah Beebe at the address listed under Inquiries. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by CSR and responsiveness by the NHLBI staff. Incomplete applications or applications deemed not responsive to the RFA will be returned to the applicant without further consideration. Applications that are submitted with only basic or only clinical research will be considered nonresponsive. 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 NHLBI in accordance with the review criteria stated below. APPLICANTS SHOULD SUBMIT THE HIGHEST QUALITY APPLICATIONS POSSIBLE TO CSR AS NO SITE VISITS NOR REVERSE SITE VISITS WILL BE HELD. 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 National Heart, Lung, and Blood Advisory Council. Factors to be considered in the evaluation of each application will be similar to those used in review of traditional research grant applications and, in addition, will include overall proposed interactions among basic and clinical research projects. Major factors to be considered in the evaluation of applications include: 1. Scientific merit of the proposed basic and clinical research projects, including significance, importance, clinical relevance and appropriateness of the theme; innovation, originality, and feasibility of the approach; and adequacy of the experimental design. 2. Leadership, scientific stature, and commitment of the principal investigator; competence of the investigators to accomplish the proposed research goals and their time commitment to the program; clinical research experience among the investigators; and the feasibility and strength of consortium arrangements. 3. Collaborative interaction among basic and clinical research components, the required clinical research component, and plans for transfer of potential findings from basic to clinical studies. 4. Adequacy of the environment for performance of the proposed research including clinical populations and/or specimens; laboratory facilities; quality of the support cores; proposed instrumentation; quality controls; administrative structure; institutional commitment; and, when needed, data management systems. 5. Adequacy of the data and safety monitoring plan for the clinical research proposed. Each project will receive a priority score. Each core will be Recommended or Not Recommended based on whether the core is essential for the proposed research and has the capability to fulfill the proposed function. Reviewers will evaluate the number of projects serviced by the core; strengths and weaknesses of the proposed approaches, resources, and interactions; whether the investigators are qualified for their role(s) in the core; and whether the proposed budget for the core is appropriate. Each application will receive an overall priority score based on the review criteria listed above. 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 adequacy of the proposed plan to share data. AWARD CRITERIA The anticipated date of award is September 30, 2003 (FY2003) for these two SCOR programs. A major factor guiding the Institute in selecting which applications to fund will be the strength of the clinical research and its integration with the basic research. Applications with weak clinical research will unlikely be funded, regardless of the overall priority score. Availability of funds and programmatic priorities will also be factored into funding decisions. INQUIRIES Written and telephone inquiries concerning the RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Special supplemental instructions for the preparation of grant applications for SCORs may be obtained by contacting program staff at the Division of Lung Diseases, as indicated below. Direct inquiries regarding programmatic issues to: Neurobiology of Sleep and Sleep Apnea Michael Twery, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, MSC 7952 Bethesda, Maryland 20892-7952 Telephone: (301) 435-0202 Fax: (301) 480-3557 Email: Twerym@nhlbi.nih.gov Airway Biology and Pathogenesis of Cystic Fibrosis Susan Banks-Schlegel, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, MSC 7952 Bethesda, Maryland 20892-7952 Telephone: (301) 435-0202 Fax: (301) 480-3557 Email: Schleges@nhlbi.nih.gov Direct inquiries regarding review issues, send letter of intent, and two copies of the application to: Chief, Review Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7178(MSC 7924) Bethesda, Maryland 20892-7924 Telephone: (301) 435-0270 Fax: (301) 480-3541 Email: Db57j@nih.gov Direct inquiries regarding fiscal matters to: Raymond Zimmerman Division of Extramural Affairs National Heart, Lung, and Blood Institute National Institutes of Health 6701 Rockledge Drive, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: (301) 435-0171 Fax: (301) 480-3310 Email: rv7g@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.838. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended by Public Health Service Act (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 Public Health Service (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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