and Human Services (HHS)
EXPIRED
ANCILLARY STUDIES IN HEART, LUNG, AND BLOOD DISEASE TRIALS Release Date: June 22, 2000 RFA: HL-00-012 (See renewal with modifications: RFA-HL-07-009) National Heart, Lung, and Blood Institute Letter of Intent Receipt Date: One month prior to application receipt dates Application Receipt Date: Applications will be accepted every three (3) MONTHS on the following receipt dates: September 11 and December 11 of 2000; March 9, June 11, September 10, and December 10 of 2001; and March 11 and June 10 of 2002. 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/PA. PURPOSE The overall goal of this initiative is to solicit research grant applications to conduct mechanistic studies in clinical trials related to heart, lung and blood diseases. Specifically, this initiative focuses on the utilization of patients and patient materials from such trials to study the mechanisms underlying the interventions, the mechanisms of disease pathogenesis, surrogate markers or biomarkers of disease activity and therapeutic effect and the mechanisms of human cardiopulmonary and hematologic function. Studies aimed at accelerating the development of new technologies within the context of the mechanistic investigations are also encouraged. Mechanistic studies in clinical trials supported by any source (industry, public and private) are eligible. Applications submitted under this program will undergo an expedited peer review and award to facilitate the timely conduct of these mechanistic studies. 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)ANCILLARY STUDIES IN HEART, LUNG AND BLOOD DISEASE TRIALS, 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 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 four years. This RFA will be active for two (2) fiscal years (FY 2001 and 2002)contingent on the availability of funds. Unsolicited competing continuation applications after this 2 year period will compete with all investigator-initiated applications according to the customary peer review procedures. Highly meritorious applications selected for funding under this RFA will receive their awards approximately 15 weeks after the application receipt date. 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 NHLBI intends to commit $3.0 million in FY 2001 and $3.0 million in FY 2002 to fund up to 8-10 new grants each year in response to this RFA. An applicant may request a project period of up to four years and a budget for direct costs of up to $225,000 (9 modules) per year, including facilities and administrative (F&A) costs on consortium arrangements. Because the nature and scope of the research proposed in each application may vary, it is anticipated that the size of each award will also vary. The parent or core clinical trial must be independently funded and will not receive support under this RFA. Phase II-IV clinical trials supported by any source (public or private) are eligible. Although the financial plans of the National Heart, Lung, and Blood Institute provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds in each fiscal year, and receipt of a sufficient number of meritorious applications. RESEARCH OBJECTIVES Background Large numbers of well characterized participants are frequently required to conduct clinical trials, especially those that require hard clinical endpoints to achieve their primary goals. These trials constitute a substantial investment and provide a unique resource of potential subjects and patient materials for studies to better understand disease mechanisms or how responses to therapy are mediated. There is general agreement within the scientific community that our understanding of many of the mechanisms underlying interventions for treatment of heart, lung, and blood diseases are limited, even in cases where efficacy has been shown. In addition, clinical trials supported by industry and other sources, including NIH, often do not incorporate studies of underlying mechanisms. Therefore, it is necessary to consider novel approaches to capitalize on these valuable and expensive clinical trials to utilize patient information and samples from clinical trials of heart, lung, and blood diseases for study of the basic mechanisms of therapeutic effect, physiologic/cellular function and disease pathogenesis. These mechanistic studies not only offer an opportunity to elucidate disease pathogenesis and correlate this information with clinical course and outcome, but a means to investigate new mechanisms and obtain new information. This information will be crucial to identifying effective surrogate markers that can be used to predict which patients are at high risk, or to design treatments, or the timing of treatments that can be targeted to patients with specific responses or characteristics. Unfortunately, the time currently required for review and award of new grant applications is often incompatible with the time-line of a clinical trial. Specifically, when a clinical protocol is finalized (which is required for applications submitted under this RFA), investigators are often ready to begin once approval is obtained from the clinical trial governing body and Institutional Review Board. The standard time frame for submission to award for a NIH investigator-initiated research grant application does not generally work well for supporting ancillary mechanistic studies and often critical time points are missed. This RFA would fill two important needs. The first would be to encourage basic scientists and clinical investigators from academia and industry to work together on ongoing clinical protocols to enable more in depth study of mechanisms of disease pathogenesis. Secondly, it will provide a means of rapidly responding to opportunities to study underlying mechanisms and surrogate markers. This approach should provide a cost efficient means of conducting mechanistic ancillary studies of disease pathogenesis within the larger context of ongoing clinical trials. The overall goal of this RFA is to support mechanistic research in clinical trials of cardiovascular, respiratory or hematologic diseases. Specifically, the goal is to utilize patients and patient materials from such trials for the evaluation of the relevant parameters to study the underlying mechanisms of disease activity and therapeutic effect, and mechanisms of human cardiopulmonary and hematologic function. Such studies would not be part of the parent or core clinical trial and are commonly referred to as ancillary studies. These studies would consist of measurements not being conducted as part of the parent clinical trial. For example, such ancillary studies might be done on the entire participant cohort or on subsets of the participants depending on the sample size required to answer the questions. They may involve physiologic or biochemical measures, imaging techniques or analyses of biological specimens from the subjects for potential genetic studies, or for other factors thought to bear on the pathogenesis of the condition or on the mechanism of the intervention. The primary objective is to help elucidate the mechanism of action, or the pathogenesis of the condition, or the validity of potential cardiopulmonary or hematologic biomarkers. These studies must not interfere with or over burden participants in the parent study. Appropriate sample size calculations are required, and all ancillary study policies from the parent study must be followed. The parent or core clinical trial must be independently funded and will not receive support under this RFA. Phase II-IV clinical trials supported by any source (public or private) are eligible. This program will utilize an expedited application process, rapid review and feedback to the Institute and applicant and modular funding to simplify budget negotiations. Research Scope The following are examples of the kinds of areas that might be studied. However, these are only examples and are not meant to be limiting. A number of potential mechanistic studies of cardiovascular disease pathogenesis are open for investigation. For example, in trials of cardiovascular and diabetes, studies might determine the validity of biomarkers or surrogate endpoints to assess disease progression. Studies of cardiac energetics (MRI, PET) before and after control of metabolic abnormalities and studies to evaluate changes in coagulation factors or inflammation with improved control of glucose or other risk factors would be appropriate. Similarly, in trials of heart failure or sudden death, imaging studies might contribute to the understanding of disease progression or mechanism of action of the intervention. Pathophysiological mechanisms of inflammatory lung diseases such as asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, acute respiratory distress syndrome (ARDS), interstitial pulmonary fibrosis, and bronchopulmonary dysplasia (BPD) may differ depending on the initial insult and may be further complicated by the patient's underlying condition. The inflammatory cascades initiated by these disease processes are complex and may result in activation of different inflammatory mechanisms. Studies are encouraged to explore the underlying mechanisms of airway injury and repair, vascular remodeling, regulation of vessel tone, airway/tissue remodeling, individual host response to lung injury, role of genetic factors in clinical heterogeneity, mechanisms underlying the maintenance and severity of asthma, and identification of surrogate markers for rejection and infection in transplant patients. A number of important mechanistic questions in the area of sickle cell disease could be studied in ongoing clinical trials. These include determining the mechanism of action of hydroxyurea in ameliorating sickle cell crises, including investigation of its effects on fetal hemoglobin levels, on adhesion of sickle red blood cells and white blood cells to endothelium in various organs, post-translational modifications of hemoglobin, identification of biomarkers for a sickle cell crisis, biomarkers to quantify graft vs. host disease in blood and marrow transplantation, and the mechanisms responsible for first-time stroke. Studies could explore thrombosis resulting from hormone replacement therapy in post-menopausal women or identify newly recognized transfusion-transmitted agents and antibodies to these agents. SPECIAL REQUIREMENTS In order to be considered responsive to this announcement, applications must propose mechanistic (not clinical) studies using ongoing heart, lung and blood related clinical trials. The use of epidemiology studies or existing cohorts for mechanistic studies are not eligible under this RFA. Applications focused solely on the development of methodology without plans for addressing the goals of this RFA will not be accepted. Studies needed to develop biomarkers or to overcome barriers such as the development of instrumentation should be integrated into the proposed research program. For information related to ongoing clinical trials supported by the NHLBI prospective applicants may wish to refer to the NHLBI clinical trials data base at: http://apps.nhlbi.nih.gov/clinicaltrials/ Prospective applicants for this RFA may or may not be investigators of the parent clinical trial(s)whose data and/or materials and/or subjects they propose to use. It is expected that applicants who are not parent study investigators will work together with the parent study investigators in developing their applications. All ancillary study applications MUST include a letter or statement documenting that patients, samples, data and/or materials are available from the parent clinical trial and the proposed ancillary study has the approval of the parent study's organization/leadership. Applications not containing such documentation will be considered non-responsive to this RFA. Applicants must submit a time line in their application demonstrating that the ancillary study can be completed within a reasonable time frame. Upon initiation of the program, periodic meetings may be organized to encourage the exchange of information among investigators who participate in this program. Travel funds for a one day meeting each year, most likely to be held in Bethesda, Maryland, must be included in the module calculation. Applicants must include a statement indicating their willingness to participate in these meetings. In addition to yearly progress reports, the Principal Investigators of grants funded under this RFA will provide brief (1-2 pages) summary reports of the outcomes of the research at the conclusion of the funding period and one year later. The reports will summarize the major scientific knowledge gained and identify other substantive outcomes such as publications, patents, and new grants, contracts, or research studies based on this mechanistic research. 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. 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) 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 URLS IN NIH GRANTS 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. LETTER OF INTENT Prospective applicants are asked to submit one month prior to the application receipt dates a letter of intent that includes: a descriptive title of the proposed research; the title of the parent clinical trial; 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 this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows review to estimate the potential review workload and to plan the review. IT IS HIGHLY RECOMMENDED THAT THE LETTER OF INTENT BE SUBMITTED, and it should be sent to Dr. Scheirer at the address listed under INQUIRIES. APPLICATION PROCEDURES Applicants are strongly encouraged to call program staff listed in INQUIRES below with any questions regarding the responsiveness of their proposed project to the goals of this RFA. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98). 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 301/710-0267, email: [email protected] and on the internet at: http://grants.nih.gov/grants/funding/phs398/phs398.html For purposes of identification and processing, item 2a on the face page of the application must be marked "YES" and the RFA number "HL-00-012" and the words "ANCILLARY STUDIES IN HEART, LUNG, AND BLOOD DISEASE TRIALS" must be entered on the face page. Applications must be received by the receipt date. Receipt dates are September 11 and December 11 of 2000; March 9, June 11, September 10, and December 10 of 2001; and March 11 and June 10 of 2002. Applications which are received after the deadline will automatically be processed for the next receipt date. Applications not received as a single package (See Special Instructions Section below) on the receipt date or not conforming to the instructions contained in PHS 398 (rev. 4/98) Application Kit (as modified in, and superseded by, the special instructions below, for the purposes of this RFA), will be judged non-responsive and will be returned to the applicant. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. 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. A sample RFA label is available at the following site: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in pdf format. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but that has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. Simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application that is essentially identical to one that has already been reviewed cannot be submitted in response to this RFA. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. Submit a signed, typewritten original of the application, including the checklist and three signed, exact, single-sided photocopies in one package to: PLEASE NOTE THAT THIS ADDRESS IS DIFFERENT FROM THE INSTRUCTIONS IN THE 398 APPLICATION PACKAGE AND FAILURE TO COMPLY WILL RESULT IN DEFERRAL OF REVIEW. Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 2030 - MSC 7720 Bethesda, MD 20892-7720 Bethesda, MD 20817 (for express mail or courier service) At the time of submission, two additional copies of the application plus all five copies/sets of the appendix material must be sent to Dr. C. James Scheirer listed under INQUIRIES. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application. SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA The research plan in the application should be limited to 15 pages, excluding references. The research plan includes specific aims, background and significance, preliminary studies, and research design and methods (Sections A to D). In the research plan, include a justification for why the proposed studies require the use of patients in this clinical trial as opposed to using patients with the same disease state but not in a trial. Methods of data analysis and power calculations must be included as well as a justification for the required sample size. A restatement of the sample size calculations from the parent clinical trial is insufficient. If appropriate to your application, discuss whether it is necessary to perform the mechanistic studies on all patients enrolled in the parent trial or whether a sub-sample would be sufficient. There must be a discussion of the statistical procedures that will be used to analyze the data. The manner in which mechanistic approaches will be related to the clinical outcomes in the main study should also be discussed. The protocol and the investigators' brochure for the parent or core clinical trial should be included with the application as part of the human subjects section. Inclusion of the complete clinical protocol within the PHS 398 grant application is intended to simplify the application process by eliminating the need to duplicate protocol details in the Research Plan section. Informed Consent form(s) from the parent clinical trial must also be included as part of this section. While drafts of the consent forms for the proposed study from all participating sites are not required, it would be useful to include them if they are available. NIH will treat as confidential any scientific, preclinical, clinical, or formulation data and information that the sponsor deems to be proprietary and confidential. To facilitate the accelerated award schedule, applicants will be notified of the need to obtain Institutional Review Board (IRB) approval for the mechanistic studies when there is the potential for an award and to provide documentation that the parent clinical trial also has IRB approval. Amended applications will be accepted for ANCILLARY STUDIES IN HEART, LUNG, AND BLOOD DISEASE TRIALS ONLY if invited by NHLBI. Applicants with minor or easily corrected problems will be invited to submit an abbreviated amendment (5 page limit and one time only) which directly addresses the questions and concerns raised in the initial review. In order to ensure coordination between the mechanistic studies and the parent or core clinical trial, the principal investigator and the sponsor of the parent or core clinical trial MUST provide written agreement for the conduct of the mechanistic studies as presented in the application. Applications submitted without this documentation will be considered non-responsive to this RFA. All procedures to protect the subject's privacy rights must be clearly described in the mechanistic study application. Prior to award, the applicant must provide to the NHLBI a memorandum of understanding signed by the applicant, an appropriate representative of the applicant institution, the principal investigator of the parent or core clinical trial, and an appropriate representative of the sponsor of the parent or core clinical trial. This memorandum will indicate agreement and will outline the specifics of the agreement for the following areas: 1) data from the mechanistic studies (including ownership, analysis, access, and release), 2) access to the data from the parent or core clinical trial (how/when) which is needed to analyze the mechanistic studies, including procedures for prevention of unblinding of the parent trial and informed consent/privacy issues for patient samples, 3) documentation of quality assurance procedures for both the parent trial and the mechanistic studies, and documentation of Data Safety Monitoring procedures for the parent trial, especially for efficacy trials, 4) ownership of intellectual property developed during the mechanistic studies, and 5) publication of the results of the mechanistic studies. MODULAR APPLICATION DETAILS: 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 $225,000 (9 modules) per year including F&A costs on consortium arrangements. 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 $225,000) and Total Costs [Modular Total Direct plus 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 F&A costs) 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NHLBI. 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 NHLBI in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Heart, Lung, and Blood Advisory 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? (6) Is there adequate documentation that patients, samples, data and/or materials are available from the parent clinical trial? 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. If the proposed research includes studies in human subjects, 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. AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o program balance. 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: James Kiley, Ph.D. Division of Lung Diseases National Heart, Lung, and Blood Institute Rockledge 2, Suite 10018 Bethesda, MD 20892-7952 Telephone: (301) 435-0233 FAX: (301) 480-3547 Email: [email protected] Peter Savage, M.D. Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 8104 (MSC 7938) Bethesda, MD 20892-7950 Telephone: (301) 435-0422 FAX: (301) 480-0868 Email: [email protected] Carol Letendre, Ph.D. Division of Blood Diseases and Resources National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 10152 (MSC 7950) Bethesda, MD 20892-7950 Telephone: (301) 435-0055 FAX: (301) 480-0868 Email: [email protected] David Gordon, M.D. Division of Heart and Vascular Diseases National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 9152 (MSC 7956) Bethesda, MD 20892-7956 Telephone: (301) 435-0555 FAX: (301)480-2858 Email: [email protected] Direct inquiries regarding review matters to: C. James Scheirer, Ph.D. Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Dr.,Room 7216 (MSC 7924) Bethesda, MD 20892-7924 (20817 for Courier) Telephone: (301) 435-0266 Fax: (301) 480-3460 Email: [email protected] Direct inquiries regarding fiscal matters to: Raymond Zimmerman Grants Operations Branch Division of Extramural Affairs National Heart, Lung, and Blood Institute 6701 Rockledge Drive, Room 7154, MSC 7926 Bethesda, Maryland 20892-7926 Telephone: 301 435-0171 FAX: 301 480-3310 E-mail: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.837, 93.838, 93.839. 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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