RFA-HD-00-010: COOPERATIVE MULTICENTER NEONATAL RESEARCH NETWORK

Department of Health
and Human Services (HHS)

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COOPERATIVE MULTICENTER NEONATAL RESEARCH NETWORK Release Date: April 3, 2000 RFA: HD-00-010 (This RFA has been reissued, see RFA-HD-04-010) National Institute of Child Health and Human Development Letter of Intent Receipt Date: April 21, 2000 Application Receipt Date: July 11, 2000 PURPOSE The National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD under a Cooperative Agreement (U10) in an ongoing multicenter clinical program designed to investigate the safety and efficacy of treatment and management strategies to care for newborn infants, particularly those related to management of low birth weight infants. The objective of this program is to facilitate evaluation of these strategies by establishing a network of academic centers that, by rigorous patient evaluation using common protocols, can study the required numbers of patients and can provide answers more rapidly than individual centers acting alone. The NICHD program staff will assist the Principal Investigators of the Neonatal Research Network and the Advisory Board in identifying research topics of high priority, and in designing and implementing protocols appropriate to the evaluation of optimal management in these areas. It is anticipated that approximately 14 to 16 clinical centers will be involved in the program. 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), Cooperative Multicenter Neonatal Research Network, is related to the priority area of low birth weight. Potential applicants may obtain Healthy People 2010 at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic non-profit organizations, public and private. Organizations should have academically-oriented divisions of neonatal medicine. The need for continuous and active communication among sites dictates that only institutions in the United States are eligible to apply. 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) cooperative clinical research cooperative agreement (U10) award mechanism, an assistance mechanism (rather than an acquisition mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients activity by involvement in the activity and otherwise working jointly with the award recipients in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreements are discussed below under Terms and Conditions of Award. FUNDS AVAILABLE NICHD intends to commit approximately $5.1 million in total costs [Direct plus Facilities and Administrative (F & A) costs] in FY 2001 to fund 14 to 16 new and/or competing continuation grants in response to this RFA. An applicant may request a project period of up to five years and a budget for direct costs of up to $200,000 per year, excluding F & A costs on consortium arrangements. Because the nature and scope of the research proposed may vary, it is anticipated that the size of awards also will vary. Although the financial plans of NICHD 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 meritorious applications. RESEARCH OBJECTIVES Background Modern neonatology medicine has introduced a number of principles of management and innovative methodologies without rigorous use of the controlled observation necessary for their objective evaluation. A major problem has been the balance between assuring prompt implementation of new technologies, procedures, treatments and drugs, and adequate evaluation of their safety and efficacy. Indeed, because of the urgent demands of sick infants, care is often based on limited knowledge of new modalities not subjected to critical studies prior to introduction and use. In a critically ill infant, an innovative idea may be tried which, if the infant"s condition improves, may rapidly set a new trend, and become the standard of care. Therefore, the incorporation into the arsenal of therapies frequently is based on limited experience, and their efficacy and/or safety have not been evaluated scientifically. In an attempt to respond to the need for well-designed clinical trials in neonatal medicine, NICHD established a Neonatal Research Network in 1986. Seven university units were selected from among respondents to an RFA. The Network Steering Committee, which consists of representatives from each Clinical Center, NICHD staff, and data center staff, evaluated several controversial issues for study. It then selected certain priority areas in which to develop protocols for randomized clinical trials. Protocols on the prevention of sepsis, intraventricular hemorrhage, pulmonary hypertension, surfactant administration, and outcome and resource requirements for very low birthweight (VLBW) infants were initiated. In addition, the Network established a generic data base of infants less than 1500 grams at birth. During the second grant period of the Neonatal Research Network (1991-1996), clinical trials were initiated on the prevention or treatment of chronic lung disease (CLD), intraventricular hemorrhage, retinopathy of prematurity, and persistent pulmonary hypertension. Studies of VLBW maturity and postnatal growth, the sequelae of the fetal drug exposure, and a standardized follow-up program also were initiated. During the third Neonatal Research Network funding period (1996 2001), intraventricular hemorrhage, retinopathy of prematurity, the treatment of persistent pulmonary hypertension, parenteral glutamine, indomethacin, erythropoieten, inhaled nitric oxide, postnatal steroids, ventilation management strategies, and outcome at follow-up were addressed. Objectives and Scope There are a number of controversial issues in neonatology that might be clarified by multicenter collaborative research. Funded Principal Investigators will cooperate with the NICHD Program Coordinator in identifying research topics of high priority and in designing protocols appropriate to the evaluation of superior, or even optimal management in these areas. The participating Neonatal Research Network members will be designated as Clinical Centers which will recruit, assess and treat subjects under the supervision of the respective Clinical Center Principal Investigator. The data center, which is funded under a separate RFA, will have primary responsibility for data management and analysis for Network research in collaboration with the Steering Committee. The NICHD expects that the ongoing trials dealing with hypothermia for asphyxiated babies, benchmarking to reduce chronic lung disease, and the follow-up program will continue into the new grant period in existing centers. New protocols may be developed before the start of the continuation. Centers that join the Network in the next award period (beginning April 1, 2001) may participate in the protocols ongoing at that time. The NICHD intends to enable the Network to initiate new protocols within the first year of the next award period. The topics of these protocols will be decided cooperatively by the Steering Committee with advice from the Advisory Board. Areas of interest include all major areas of newborn pathophysiology: cerebral function, pulmonary physiology, gastrointestinal function and nutrition, immunology, etc. Also of interest are evaluation of drugs in the newborn, the rapid transfer of new technologies to neonatal medicine, strategies to reduce the cost and preserve the quality of neonatal care, and long-term outcome. Guidance and Management Structures The management of the Neonatal Research Network includes three committees as described below under Terms and Conditions of Award/Collaborative Responsibilities. In addition, the Network has established Policies and Procedures that govern its operations, including publications. These documents are under periodic review, and may be amended and supplemented at the discretion of the Steering Committee and the NICHD. SPECIAL REQUIREMENTS The NICHD invites applications both from current members of the Neonatal Research Network (competing renewal applications) and from prospective members (new applications). Minimum requirements for applicants are as follows (see APPLICATION PROCEDURES/Application Instructions, below, for detailed application instructions): Applicant Clinical Centers must have at least 500 admissions per year currently in the unit. No more than 30 percent of admissions should be outborn. Large perinatal centers will be given preference over combined services composed of a small inborn unit and a transfer/tertiary care service. An established neonatal follow-up program with experience in following patients and a designated facility must be in place. The applicant must have an established neonatal/perinatal data system, preferably computerized, to collect and tabulate statistics. A research nurse must be designated for the full-time nurse coordinator position. To provide peer reviewers and NICHD an idea of the capabilities of investigators, all applicants must submit a concept protocol, briefly (two to three pages) summarizing a project that the applicant might submit to the Network for possible implementation at all Network centers. The departmental and institutional commitments to collaborative neonatal research should be clearly documented by providing letters to the Principal Investigator, and by citing evidence of past support. Terms and Conditions of Award The following Terms and Conditions of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations in 45 CFR Parts 74 and 92 and other HHS, PHS and NIH grant administration policies. The administrative and funding instrument used for this program will be the cooperative agreement (U10), an assistance mechanism (rather than an acquisition mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient"s activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardee(s) for the project as a whole, although specific tasks and activities in carrying out the studies will be shared among the awardees and the NICHD Program Coordinator, as described in these terms and conditions. (The substantial programmatic involvement by the NICHD Program Coordinator is above and beyond the levels required for traditional program management and stewardship of awards.) 1. Awardee Rights and Responsibilities The responsibilities and authorities of the awardees will be as follows: o Identification of priority issues for research. o Development and implementation of common protocols. o Collection and transmission of accurate data in a timely manner. o Analysis of data and publication of results of the Neonatal Research Network studies. All parties will agree to accept the coordinating role of the group and the participatory and cooperative nature of the group process. The individual members will be required to project patient enrollment for a specific protocol during a specified time frame, continuation and level of funding will be based on actual recruitment. The Neonatal Research Network will retain custody of and have primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS and NIH policies. 2. NICHD Staff Responsibilities Traditional program management/stewardship responsibility for review and oversight of the cooperative agreement award will reside with the Neonatal Research Network Program Official. This role will include the following: o Assurance of the scientific merit of the trials, including the option to withhold support of a participating center if technical performance requirements such as protocol compliance, enrollment targets, or randomization of subjects are not met. o Initiation of a decision to modify or terminate a study based on the advice of the data center, Data Safety and Monitoring Committee, and Advisory Committee with the mutual consent of the Steering Committee. The role of the participating NICHD Neonatal Research Network Program Coordinator will be to aid the awardees and the Steering Committee in the following ways: o Assistance in the identification of important areas of study. o Assistance in the development of study protocols. o Assistance in the development and review of capitation-based budgets, including the identification of study costs and special institutional needs. o Assistance in the review and evaluation of each stage of the program before subsequent stages are started, in conjunction with the Steering Committee and the Advisory Board. o Assistance in the efficient conduct of the trials, including ongoing review of progress, possible redirection of activities to improve performance and cooperation, and frequent communication with other members of the Steering Committee. o Participation on the Steering Committee and all active subcommittees. o Assistance in reporting results in the community of investigators and health care recipients. 3. Collaborative Responsibilities The management of the Neonatal Research Network includes three committees whose functions are as follows: o A Steering Committee will be responsible for protocol development, assisted by the Advisory Board and the Data Safety and Monitoring Committee. The Steering Committee will have primary responsibility for the conduct of protocols and the preparation of publications. The Steering Committee will be composed of all Principal Investigators, one representative from the data center, and one NICHD staff member, a neonatologist from the Pregnancy and Perinatology Branch (the Neonatal Research Network Program Coordinator). The Neonatal Research Network Program Coordinator will be the only voting NICHD staff member of the Steering Committee. A member of the NICHD Grants Management Branch advises the Steering Committee on funding matters. An outside chairperson, who is not participating as a Principal Investigator, will be selected by the NICHD. o An Advisory Board will advise the Steering Committee in the identification and prioritization of topics for Network research. The Advisory Board, chosen by the NICHD with the advice of the Steering Committee, will be composed of individuals with expertise in clinical trials, biostatistics, epidemiology, perinatology, and neonatology, the Chairperson of the Steering Committee, the data center Principal Investigator, the Director of the NICHD Center for Research on Mothers and Children (CRMC), and the Neonatal Research Network Program Coordinator. Additional members will participate based on the need for specific expertise. o A Data Safety and Monitoring Committee (DSMC) will monitor the safety of ongoing clinical trials and advise on their conduct. The DSMC will be established by NICHD and will represent expertise in clinical trial design and conduct, perinatology, neonatology, basic science, and ethics. In addition, the Network has established Policies and Procedures that govern its operations, including publications. These documents are under periodic review, and may be amended and supplemented at the discretion of the Steering Committee. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NICHD may be brought to arbitration. An arbitration panel will be constituted, consisting of three members: one selected by the Steering Committee (with the NICHD member not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by NICHD, and the third member selected by the two previously selected members. This special arbitration procedure in no way affects the awardee’s right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulation at 45 CFR Part 16. 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 are 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, published in the Federal Register of March 28, 1994 (FR 59-14508- 14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994, and available 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, published in the NIH Guide for Grants and Contracts, March 6, 1998, and available at: http://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. 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 identities of other key personnel and participating institutions, and the number and title of this RFA. 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 NICHD staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to Dr. Linda L. Wright at the address listed under INQUIRIES, below, by April 21, 2000. 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. 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, on the Internet at http://grants.nih.gov/grants/funding/phs398/phs398.html, 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, E-mail: Grantsinfo@nih.gov. Application Instructions The NICHD invites applications both from current members of the Neonatal Research Network (competing renewal applications) and from prospective members (new applications). Instructions accompanying the PHS 398 (rev. 4/98) are to be followed in completing these applications. Applications should address the following items: A. Requirements for Applicants 1. Academic Productivity Provide evidence of recent research productivity by the applicant Clinical Center in previous or present clinical trials, especially of a cooperative, multicenter nature. Specifically, contributions in key areas such as protocol design, patient recruitment, data analysis and interpretation, and publication are important. Applicants who are current Neonatal Research Network members should describe their participation in Network research during the current competitive segment in detail, i.e., GDB infants per year, number of patients who were recruited to each study, and subcommittee memberships and chairmanships. New applicants should describe their recent participation in at least one randomized clinical trial and one observational study, preferably of a multicenter nature, providing similar information to that requested from current Network members. 2. Neonatology Staffing Participants must be based in a level III neonatal intensive care unit that admits both inborn and outborn patients. Physician staffing of the Clinical Center should include at least four full-time board-certified neonatologists. Provide complete descriptions of their training and qualifications in both clinical care and research, and their previous and current involvement in clinical research. Specifically, the academic status and academic career development pathways should be described. The approximate percentage time protected for research by the academic department should be specified. The Principal Investigator should be a practicing neonatologist, his/her clinical, academic, administrative, and research commitments should be described in detail. 3. Available Population Applicant Clinical Centers must have at least 500 admissions per year currently in the unit. No more than 30 percent of admissions should be outborn. Large perinatal centers will be given preference over combined services composed of a small inborn unit and a transfer/tertiary care service. Applicants that have numbers of births near the minimum or have experienced a recent decline in annual admissions should describe this decline and document efforts to maintain access to an adequate number of neonatal patients for research purposes. The patient population served by the Clinical Center should be characterized by demographics, obstetric parameters, and payment status. Indications should be given of the proportions of various subgroups, including minorities, that have been eligible and actually have been randomized in previous or current clinical trials (see also section on Inclusion of Women and Minorities). 4. Maternal Fetal Medicine Unit The Clinical Center should be located in an institution with a perinatal program that delivers high-risk pregnancies and has one or more perinatologists active in clinical research on staff. A history of cooperation between neonatology and obstetrics towards excellence in clinical care, maintenance of a data base, and research productivity should be documented. An obstetrician at the institution who has interest and experience in clinical research and is willing to participate in the Neonatal Research Network should be designated. Such individual(s) must commit to serve as a consultant and possible collaborator in Network research. The academic status and career development pathways of such individual(s) must be described. A description of the organization and service load of the Maternal Fetal Medicine Units at the institution, including its research activities, must be included. If the institution submits applications in response to both the Maternal Fetal Medicine Unit RFA (HD-00-009) and the Neonatal Research Networks RFA, the applicant must describe how the two research programs will be integrated. 5. Facilities and Clinical Capabilities The applicant Clinical Center should have a full range of pediatric subspecialists, state-of-the-art facilities and clinical capabilities, and excellent support staff. The applicant Clinical Center should include a detailed description of facilities, equipment, and clinical capabilities, pediatric subspecialists and support staff, specialty clinics, laboratory facilities, and imaging capabilities. The availability of an institutional research pharmacy and respiratory therapy program capable of supporting clinical research also should be documented. An established neonatal follow-up program with experience in following patients and a designated facility must be in place. The professional staff should include a developmental pediatrician or neonatologist with similar expertise. Specialists available to consult should include pediatric neurology, ophthalmology, orthopedics, surgery, physical and/or occupational therapy, nutrition, and social services. A system of ongoing follow-up data collection must be documented including the population followed, compliance rates, schedule of follow-up visits, funding sources, as well as established policies and procedures for conducting clinical research in these facilities. A Biographical Sketch of the individual responsible for the Network Follow-Up study and a letter of support from the director of the follow-up program should be included. All applicants, both new and competing renewals, also are invited to describe briefly any special research strengths that may be relevant to Network research. Such strengths would represent state-of-the-art scientific capabilities that might be shared or made available to the Network, to expand the scientific productivity of Network research. For example, an ongoing specialized registry or capabilities in areas such as PET scanning, prenatal diagnosis, molecular biology, and clinical pharmacology represent some of the relevant strengths that could be included. Special administrative strengths also may be described. For example, both competing continuation and new applications may present the availability of potentially collaborating neonatal units in medical centers with which affiliations have been developed by the applicant institution for clinical research. The requirements described above must be met by such affiliated institutions. Centers that propose to combine institutions or multiple sites must justify the proposed organization and provide a detailed logistical plan for cost-effective management. 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 or other funded perinatal research centers as resources for conducting the proposed research. If so, a letter of agreement that identifies the level of support from either the GCRC program director or Principal Investigator should be included with the application. A description of whether, and how, policies and procedures may have been modified to support neonatal clinical research in the past must be provided. 6. Perinatal Data System The Clinical Center must have an established neonatal/perinatal data system, preferably computerized, to collect and tabulate statistics. Applicants must provide a detailed description of the variables collected and the data quality and management activities. The applicant also should illustrate how the system has been used recently to plan and perform clinical research. All successful applicants must be willing to provide complete, accurate, and timely data to the Neonatal Research Network registry. 7. Research Nurse Staffing A research nurse must be designated for the full-time nurse coordinator position. Also, additional research nursing staff should be available. Provide descriptions of these individuals training, experience, and involvement in clinical research. 8. Proposed Protocol Concept (all applicants) To provide peer reviewers and NICHD an idea of the capabilities of investigators, all applicants must submit a concept protocol, briefly (two to three pages) summarizing a project that the applicant might submit to the Network for possible implementation at all Network centers. The proposed concept will serve as an indicator of the applicant"s ability to participate in the development and design of cooperative protocols in the Network and reflect the problems and population available in the Network. The concept may not actually be performed by the Network, although it is anticipated that funded Neonatal Research Network centers will be invited to submit the concepts included in their applications to the Network Steering Committee for consideration. For purposes of this RFA only, the protocol concept should address ONE of the following topics: nutrition in the less than 1kg neonate, prevention of CLD, improvement in neurologic outcome, or prevention/treatment of sepsis in the VLBW neonate. The concept should also demonstrate use of the applicant"s perinatal data system to estimate numbers of available patients eligible for the protocol at his/her institution. The concept should address relevant ethical issues and the appropriate inclusion of minorities as subjects. 9. Intent to Participate There must be a clearly expressed intent to participate in a cooperative manner with other Neonatal Research Network Clinical Centers, the NICHD, and the data center, in all aspects of Network research as outlined in this RFA. 10. Departmental and Institutional Commitments The departmental and institutional commitments to collaborative neonatal/perinatal research and to prioritization of Network research should be clearly documented by providing letters to the Principal Investigator, and by citing evidence of past support. This institutional assurance to provide support should address areas such as fiscal administration, personnel management, space allocation, procurement, planning, equipment, and budgeting. 11. Acceptance of Budgetary Mechanism Assurance of cooperation with the policy of capitation of research costs for each individual protocol, in addition to a base budget, should be provided from the department and from the institutional office of sponsored research programs. B. Budget Preparation The instructions for budget requests provided with the research grant application form PHS 398 (rev. 4/98) should be followed. F & A costs will be awarded in the same manner as for research project grants (R01). Budgets will be reviewed on the basis of appropriateness for the work proposed. Allowable costs and policies governing the research grants programs of the NIH will prevail. In planning the budget section of the application each applicant should submit budget estimates for all years. The first-year budget at the time of application will be limited to a BASE BUDGET with maximum allowances as follows: Principal Investigator: 10 percent effort Research Nurse Coordinator: 100 percent effort Data Entry Clerk: 50 percent effort Supplies and Small Equipment (itemized and justified): Not to Exceed $4,500 Travel: (a total of 10 trips to Bethesda per Network team) as appropriate Other costs (itemized and individually justified): Not to Exceed $2,500 When an application has been favorably recommended and is being considered for funding, the applicant will be required to complete protocol budgets for those studies underway within the Network. These budgets will consist of specific protocol-related costs and will be capitated on the anticipated number of subjects to be enrolled in the study at the applicant Clinical Center. Ongoing annual budgets of Neonatal Research Network members will be based on individual protocols, which will be funded through a capitation system. Each Clinical Center will be given base costs (listed above), in addition to a flat fee per patient successfully enrolled and completed. For centers with GCRC funding, applicable capitation funds will be reduced relative to the amount of GCRC support. The Principal Investigator will be required to project patient enrollment for a specific protocol during a specified time frame, continuation and level of funding will be based on actual recruitment. Future years budgets should be limited to base budget costs, with an annual increment of base salary and travel costs not to exceed three percent (the maximum amount available for equipment and supplies will not increase). Federal agencies shall use the negotiated rates for facilities and administrative (F&A) costs in effect at the time of the initial award throughout the each competitive segment of the project. Award levels for sponsored agreements may not be adjusted in future years as a result of changes in negotiated rates. Submission Instructions The RFA label available in the PHS 398 (rev. 4/98) application form must be stapled to the bottom of the face page of the application and must display the RFA number HD-00-010. A sample RFA label is available at http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note this is in the pdf format. 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. 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 should be sent to: L. R. Stanford, Ph.D. Director, Division of Scientific Review National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E03, MSC 7510 Bethesda, MD 20892-7510 Rockville, MD 20852 (for express/courier service) Telephone: 301-496-1485 Applications must be received by July 11, 2000. 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 CSR and for responsiveness by the NICHD. 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 NICHD in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Advisory Child Health and Human Development Council. Review Criteria o Criteria for Evaluation of Concept Protocol The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In their 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 methods? 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? o Criteria for Evaluation of Overall Application (1) Qualifications, experience, and commitment of key personnel: Scientific, clinical, and administrative abilities and academic productivity of the Principal Investigator, the follow-up staff, and other team members, Knowledge and experience in areas relevant to the conduct of collaborative clinical research, especially randomized clinical trials, in neonatal medicine. This should include specific experience in research design, Commitment of staff time for the satisfactory conduct of the study, Experience and qualifications of team members who would be responsible for data quality and management activities. (2) Protocols and Procedures: Quality of the Clinical Center"s participation in either (a) (current Network members) Network protocols during the current grant period or (b) (new applicants) a randomized, clinical trial in the recent past, Willingness to work and cooperate with other Neonatal Research Network units and the NICHD in the manner summarized in this RFA, Optional research strengths, as presented. (3) Facilities and Management: Adequacy of administrative, clinical, and data organizational management facilities as described in the minimum requirements, Institutional assurance to provide support to the study in such areas as fiscal administration, personnel management, space allocation, procurement, planning, equipment and budgeting, Optional administrative strengths, such as affiliations with other research units. In addition to the above criteria, in accordance with NIH policy, all applications also will 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 also will 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. SCHEDULE Letter of Intent Receipt Date: April 21, 2000 Application Receipt Date: July 11, 2000 Peer Review Date: October 2000 Council Review: January 2001 Earliest Anticipated Award Date: April 1, 2001 AWARD CRITERIA Applications recommended by the National Advisory Child Health and Human Development Council will be considered for award based primarily on scientific and technical merit, as determined by peer review. Program balance, that is, the scope and variety of research strengths to enable a successful collaborative program, will be considered. Final selection of Clinical Centers for funding may be based partly in the need for diversity in the study population. Availability of funds may also determine the awards made. 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: Linda L. Wright, M.D. Pregnancy and Perinatology Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 4B03F, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-0830 FAX: (301) 496-3790 E-mail: WrightL@mail.nih.gov Direct inquiries regarding fiscal matters to: Ms. Joy Knipple Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17E, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-4165 FAX: (301) 402-0915 E-mail: jk173r@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act, as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routing 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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