Full Text HD-97-009 DATA COORDINATING CENTER for the MATERNAL-FETAL RESEARCH NETWORK NIH GUIDE, Volume 26, Number 23, July 18, 1997 RFA: HD-97-009 P.T. 34 Keywords: Data Management/Analysis+ Clinical Trial National Institute of Child Health and Human Development Letter of Intent Receipt Date: August 1, 1997 Application Receipt Date: September 19, 1997 PURPOSE The National Institute of Child Health and Human Development (NICHD) has a strong and ongoing interest in clinical research in maternal-fetal medicine, as exemplified by its establishment of the Maternal-Fetal Medicine Units (MFMU) Network in 1986. Support of the Network has continued until the present time, with recompetition of the clinical centers in 1991 and again in 1996. Currently, the Network consists of 13 clinical centers, a single data coordinating center independent of any of the clinical centers, and NICHD. The Network Data Coordinating Center (DCC) is also supported with a cooperative agreement. The incumbent grantee has served the Network since its inception. The Center provides statistical consultation, data management, and data analysis, in addition to various logistical services required in the multi-center research program of the Network. The current competitive segment for the DCC ends March 31, 1998. The NICHD intends to continue support of the DCC for five years to permit completion of ongoing studies and initiation of several new randomized clinical trials and other studies in obstetrics. NICHD does not intend to limit the competition to the incumbent grant for the DCC, but to invite other applications as well. Therefore, the Pregnancy and Perinatology Branch, Center for Research for Mothers and Children, NICHD, invites submissions of applications for the DCC. HEALTHY PEOPLE 2000 The Public Health Service is committed to achieving the health promotion and disease prevention objectives of Healthy People 2000, a PHS-led national activity. This Request for Applications (RFA), Data Coordinating Center for MFMU Network, is related to the priority area of Maternal and Infant Health. Potential applicants may obtain a copy of Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or Healthy People 2000" (Summary Report: Stock No. 017-001-00473) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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. Organizations should have experience in functioning as a statistical coordinating center for multi-center research, including randomized controlled trials and observational studies of both a medical (preferable neonatal and perinatal) and a psychological nature. The need for continuous and active communication among sites and with the NICHD dictates that only U.S. institutions with a branch or central office in the Washington, DC metropolitan area are eligible to apply. MECHANISM OF SUPPORT The administrative and funding instrument to be used for this program will be a cooperative agreement (U01), 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 partnership role. Details of the responsibilities, relationships and governance of the study to be funded under cooperative agreements are discussed later in this document under the section Terms and Conditions of Award. The total project period for applications submitted in response to the present RFA may not exceed five years. The anticipated award date is April 1, 1998. NICHD intends that the ongoing Cooperative Agreements will be recompeted every five years, depending on available funds. FUNDS AVAILABLE It is anticipated that one award for a Data Center will be made, with an estimated total cost of $2 million (including direct and facilities and administrative costs) in the first year. Although this program is provided for in the financial plans of the NICHD, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES A. Background In 1986, the National Institute of Child Health and Human Development (NICHD) established an administrative framework to conduct multicenter randomized controlled trials (RCTs) and other prospective clinical studies in obstetrics. The Maternal-Fetal Medicine Units (MFMU) Network originally included seven MFMU divisions at leading U.S. research universities, and was expanded in 1991 to encompass 11 centers. NICHD is closely involved in the selection of research topics, in the study designs, in analysis of data, and also provides funding for the Network. Finally, in 1996, another re-competition enlarged the Network further to 13 centers representing about 70,000 births per year. A major reason for establishing the Network was the persistence of a relatively high rate of low birth weight infants in this country. Premature and growth-restricted infants account for a disproportionately large share of infant morbidity and mortality, and subsequent developmental problems, such as cerebral palsy. The improvement in infant survival rates in the U.S. in recent years is largely attributed to increasingly effective neonatal intensive care of low birth weight infants. Thus, further progress in perinatal health will depend on the prevention of low birth weight. The primary purpose of the Network is to promote research emphasizing such prevention. The second factor leading to the establishment of the Network was the growing recognition that modern obstetrical management-especially of high-risk pregnancies-has sometimes utilized treatments that have not been adequately tested for efficacy. Like most other medical specialties, maternal-fetal medicine has enthusiastically adopted certain managements, only to have to modify or replace them after extensive clinical experience has failed to confirm their promise. Thus, another purpose of the Network was to foster research that would provide better scientific evidence on which to base obstetric practice, particularly before widespread application of new approaches. Currently, the Network is conducting several randomized trials and observational studies relating to preterm birth prevention and high-risk obstetrics. B. Objectives The awardee is expected to cooperate with the clinical investigators at the 13 Network Clinical Centers, and with the Program Officer and other participating staff at the NICHD, in the design, and conduct of protocols, analysis of data, and reporting of results from Network research. Systems for data collection, analysis, coordination, and quality assurance are essential. Required data summaries will be provided to the Network Steering Committee, NICHD, the Data Monitoring and Safety Committee, and others as determined by the Steering Committee. Logistical services for providing study drugs, collected biological fluids, and other supplies for the conduct of studies will also be provided. Content of Application The application should have (1) an introduction, either (2a) a progress report (current DCC grantee only) or,(2b) a description of relevant capabilities and experience (other applicants) and (3a) or (3b) a research plan for the next competitive segment. The progress report/description and the research plan must incorporate the following minimum requirements. (1) Minimum Requirements for the Data Coordinating Center o Staff must be prepared to cooperate effectively in all Network functions with NICHD and the clinical centers. o The Centers primary offices must be located in the Washington, DC metropolitan area. o The Center must demonstrate prior experience as a data coordinating center in multicenter studies in obstetrics during the previous five years. o The Principal Investigator, and other staff, must have appropriate expertise and capability in biostatistics, data management, data analysis, and project management. o The Principal Investigator must possess a doctoral degree and be willing to be committed to at least 85% time on Network activities. o The Center must have the ability to assist in designing protocols, data collection forms, study manuals, and data collection systems, including distributed data entry. o The Center must have experience in developing and maintaining data quality control systems. o The Center should have the capability to generate monthly reports on subject enrollment in several concurrent studies; quarterly reports on enrollment and clinical center performance; appropriate reports for the use of the Network Data and Safety Monitoring Committee once or twice yearly; and special reports as may be needed below. o The Center must demonstrate successful experience in assisting clinical investigators prepare manuscripts on multicenter research for publication. o The Center must have experience arranging logistical services for multicenter clinical trials, such as assuring appropriately prepared and labeled supplies of study medications for the clinical centers. o The Center must provide evidence of its management capability (a) to estimate appropriate and reasonable resources needed for individual projects in its role as a Data Coordinating Center of multicenter trials, (b) to manage those resources efficiently during the research, (c) to adjust the assigned resources as the work changes qualitatively and quantitatively during the research, (d) to report these resource allocations to NICHD periodically, and (e) to sub-contract with outside organizations to supplement its own resources, as needed. (2a)Progress Report (incumbent center only) o Describe how the DCC has cooperated effectively in all MFMU Network functions with the NICHD and the clinical centers. o Describe the DCC facility and how it has been used for MFMU Network functions. o Describe how staff strengths in biostatistics, data management, data analysis, and project management have been used in MFMU Network activities. o Describe the commitment of the Principal Investigator during the previous grant period. o Describe processes used by the DCC in assisting protocol design, data forms preparation, manual preparation, and in data collection for the Networks. o Describe the performance of the DCC in data quality control for the Network. o Describe the record of the DCC in generating data and performance reports on Network clinical center activities. o Describe the contributions of the DCC in preparing manuscripts from MFMU Network studies. o Describe how logistical services have been arranged by the DCC for MFMU Network protocols. o Describe the organizational systems used to assign and adjust its resources to specific protocols conducted by the MFMU Network during the previous grant period. o Illustrate the calculation of costs of all DCC work contributed to the performance of one specific protocol conducted by the MFMU Network during the previous grant period, namely, the Preterm Premature Rupture of Membranes randomized clinical trial. (2b) Description of Capabilities and Experience (new applicants only) o Describe the DCC applicants previous successful collaboration in multicenter research in obstetrics within the last five years. o Describe the applicants facility and how it has been used for multicenter clinical research. o Describe how DCC staff strengths in biostatistics, data management, data analysis, and project management have been used in multicenter clinical research. o Describe the extent of commitment of the DCC Principal Investigator in previous multicenter clinical research. o Describe the processes used by the DCC applicant in assisting protocol design, forms and manual preparation, and in data collection for previous multicenter clinical research. o Describe the performance of the DCC applicant in data quality control in previous multicenter clinical research. o Present the DCC applicants record in generating reports on data and performance of clinical center activities in previous multicenter clinical research. o Summarize the DCC applicants contributions in preparing manuscripts from previous multicenter clinical research. o Describe how logistical services have been arranged by the DCC applicant in previous multicenter clinical research. o Describe the organizational systems used by the DCC applicant to assign and adjust its resources to participate in multicenter clinical research. o Illustrate the calculation of costs of all the DCC applicants work contributed to the performance of one specific clinical protocol conducted in a multicenter setting during the past five years. The sample size and quantity of data accumulated and analyzed should be specified. (3a) Research Plan for the Next Applicant Competitive Segment for the Incumbent o Statement of intent to collaborate in a manner consistent with the terms of award. o Plans and estimated timetables for all ongoing and planned (include BEAM, progesterone and terbutaline) MFMU Network protocols to be completed, the data analyzed, the results published, and the data archived. o Plans for staff allocation to meet the demands of the plans and timetables in above. o Describe any planned modifications in the DCC processes to be used in protocol design, data forms preparation, data collection, data quality control, reports generation, manuscript preparation, and provision of logistical services for MFMU Network protocols. o Describe any planned modifications in the organizational systems to assign and adjust resource allocation during protocol performance. This should include any potential for outsourcing to meet short-term needs. o Describe new procedures to increase DCC operational efficiency and to decrease cost. o Assume that three new protocols, including two randomized clinical trials and one observational study, were planned but not yet implemented by the Network Data Center applicant. Assume, however, for this exercise that the three studies plan to collect data on 1500 items and 500 items for the randomized trials, respectively, and on 300 and 800 items from the observational study during the first year (assume no actual data collection). Assume that the proportion of distributed data entry for the two randomized trials is 90% and 30%, respectively, and 100 and 50% for the observational study. Using these assumptions, estimate the minimal base costs associated with providing professional and support staffing, and with the preparations necessary to receive and process data from the four studies during the first year. o Describe the method to be used by the applicant in calculating all operational costs per protocol and per enrolled patient for all DCC functions. o Describe in general terms a contingency plan to transfer all DCC functions for one or more active protocols from the incumbent to another DCC entity which may be successful in the competition. This contingency plan should address the feasibility of transferring specific protocols at various stages of development, including design, enrollment, and analysis. (3b) Research Plan for the Next Competitive Segment for Other (Non-Incumbent) Applicants o Describe the applicants perception of its potential role in the MFMU Network. o Provide a statement of intent to collaborate in a manner consistent with the terms of award. o Propose an operational structure for providing and coordinating all DCC functions for several Network protocols simultaneously. This should include lines of responsibility/authority for professional staff. o Description of any modifications in the applicants current processes used to provide DCC functions that may be made if the applicant were to be selected as the Network DCC. o Propose an idealized staffing pattern for providing DCC functions from protocol design through analysis. This should include provisions for adjusting staff time commitments during the life of a study. o Propose an administrative and management structure that would support and enhance the operational structure. o Propose administrative and management functions that would assure continuing attention to cost-efficiency and productivity. This should include adjustment of resource allocation during protocol performance and the potential for outsourcing to meet short-term needs. o Propose methods to be used to assure effective communication between DCC staff and other components of the MFMU Network, including NICHD and the 13 Clinical Centers. o Describe in general terms, a contingency plan to accept all DCC responsibility and functions for one or more ongoing Network protocols that might be transferred from the incumbent DCC. This plan should address the feasibility of protocol transfer at various stages of development, including design, enrollment, and analysis. o Assume that three new protocols, including two randomized clinical trials and one observational study, were planned but not yet implemented by the Network Data Center applicant. Assume, however, for this exercise that the three studies plan to collect data on 1500 items and 500 items for the randomized trials, respectively, and on 300 and 800 items from the observational study during the first year (assume no actual data collection). Assume that the proportion of distributed data entry for the two randomized trials is 90% and 30%, respectively, and 100 and 50% for the observational study. Using these assumptions, estimate the minimal base costs associated with providing professional and support staffing, and with the preparations necessary to receive and process data from the four studies during the first year. o Describe the method to be used by the applicant in calculating all operational costs per protocol and per enrolled patient for all DCC functions. C. Reference Material Information about protocols, their manual of operations, and about characteristics of the data sets of the several studies will be provided by NICHD staff at an open meeting to be held in Bethesda, Maryland on August 4, 1997. All interested applicants are invited to attend at their own expense. Details about the meeting will be provided by the scientific project officer listed under INQUIRIES. Budget Preparation The instructions for budget requests provided with the Research Grant application form (PHS 398) should be followed. Facilities and administrative costs will be awarded in the same manner as for research project grants. 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 requests for all years. Ongoing annual budgets of the Data Center will consist of base costs (see Appendix I), in addition to a capitation fee. At such time as an application has been favorably recommended and is being considered for funding, the Data Center will be required to complete a protocol budget reflecting specific protocol-related costs to be based on the number of patients to be recruited to the protocol and the actual time and effort expended. Capitation awards will be made before implementation and will be revised based on actual recruitment and management costs. Funding for extended analyses will be limited and must be justified on a protocol-by-protocol basis, based on actual time required for analyses. Biostatistical staff with advanced degrees must be justified. Future years budgets should be limited to base budget costs, with an annual increment not to exceed three percent. SPECIAL REQUIREMENTS The NICHD has established the MFMU Network in order to conduct clinically important research that requires a multicenter setting. The Network consists currently of 13 clinical centers with central data coordination and analysis. Both the clinical centers and the data coordinating center are supported by cooperative agreements, which are assistance mechanisms that have substantial involvement of NICHD program staff, beyond the level usually required for program management of research grants. 1. All components of the Network agree to accept the collaborative and participatory nature of the Network concept. 2. The Network Steering Committee, consisting of an outside Chairperson, MFMU Network Program Officer, Data Coordinating Center Principal Investigator, and Clinical Center Principal Investigators, instigate and oversee all Network research. A staff member of the Grants Management Branch, NICHD, serves in an advisory capacity to the Committee. a. The functions of the Steering Committee are as follows: o Identify study topics, considering the relevant research questions, and available resources. o Protocol development, with delegation to protocol subcommittees. o Timely reporting of data. o Analysis and interpretation of data in conjunction with the DCC. o Participation in decision to modify or terminate a study based on the advice of the Data and Safety Monitoring Committee, and the NICHD. o Reporting of results via preparation of abstracts, manuscripts for publication, and presentation at meetings. 3. The NICHD staff member(s) on the Steering Committee will be involved as follows: o Assist with the development of the study protocols. o Provide technical information for the development and review of the capitation-based budgets by the Pregnancy and Perinatology Branch Chief, including the identification of study costs and special institutional needs. o In conjunction with the Principal Investigators, review and comment on each stage of the program before subsequent stages are started, including the options of modification, or termination by mutual agreement. o Collaborate in analysis and reporting of results to the community at large. a. The NICHD staff member on the Steering Committee will also be responsible for monitoring, using consultants, as appropriate, the data management and quality assurance systems of the Data Coordinating Center, and for evaluating the cost-effectiveness at the Center. Performance of the DCC will also be evaluated by: o Quality and quantity of participation in collaborative Network research. o Reports to clinical centers on their performance. o Reports to the Data Monitoring and Safety Committee. o Annual progress reports for non-competitive renewal. o Site visit findings. 4. An Advisory Board advises the Steering Committee in the identification and prioritization of topics for Network research and the preparation of publications. The Advisory Board, chosen by the NICHD with the advice of the Steering Committee, is composed of individuals with expertise in clinical trials, biostatistics, epidemiology, perinatology,and obstetrics; the Chairpersons of the Maternal Fetal Research Network and the Neonatal Research Network, the Program Officials of the both Networks, the Director of the CRMC; and the Principal Investigators of the Data Centers. 5. Programmatic responsibility for review and oversight of the cooperative agreement will reside with Chief, Pregnancy and Perinatology Branch. The NICHD Program Official for the Network will make recommendations to the Chief, Pregnancy and Perinatology Branch. This role will include the following: o Option to withhold support from a participating clinical unit if technical performance requirements such as complying with the protocol, meeting enrollment targets and randomizing subjects are not met. o Option to withhold support from the DCC if technical performance requirements such as protocol support, data acquisition and analysis targets, and adequate quality assurance of data, are not met. o Continual review of all activities to ensure objectives are being met, to re-direct activities, or to improve cooperation and performance. 6. Cooperative agreements are assistance mechanisms and are subject to the same administrative requirements as grants. As such, pertinent DHHS, PHS, and NIH grant regulations, policies, and procedures are applicable. Business management aspects will be administered by the NICHD Grants Management Branch. 7. Funding of the DCC for the first year of the next competitive segment will consist of two parts: a. A base budget, representing all fixed costs estimated from the anticipated pre-enrollment workload. b. Capitation funding, based on the amount of data and the number of patients enrolled in each of the active, enrolling protocols. A capitation budget for each protocol, determined as follows: o The cost per patient will initially be determined with actual ime and effort data, and may be corrected, after review by the NICHD, during implementation. Recruitment estimates (number of patients per month) will be used to make an award at the start of implementation. Awards may be revised (either upward or downward) as actual recruitment rates are noted. o The foregoing budget mechanism is intended to provide equitable and reasonable support for the research efforts actually expended in these clinical studies. 8. The Data and Safety Monitoring Committee (DSMC), is established to review and interpret protocols, review specifications, and review and interpret study data in order to insure the safety of study subjects and provide the NICHD with advice on the progress of the study. The members of the DSMC are chosen by NICHD and are experts in ethics, clinical trial design, biostatistics and neonatology. The Chairperson will be appointed by the NICHD. The Deputy Director of the Center for Research for Mothers and Children (CRMC), will serve as the Executive Secretary of the DSMC and liaison to the Steering Committee. 9. Arbitration procedures will be instituted in addition to the customary programmatic and financial negotiations which occur in the administration of grants, only when agreement cannot be reached on scientific programmatic issues between the awardee and the NICHD that may arise after the award. In that event, an arbitration panel will be formed consisting of one person selected by the Principal Investigator, one person selected by the NICHD, and a third person selected by these two members. The decision of the arbitration panel will be binding. 10. The special terms of Award of Cooperative Agreement are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, DHHS grant administration regulations at 45 CFR Part 74 and other DHHS and NIH grant administration policies. The NICHD review procedure in no way affects the right of a recipient of a cooperative agreement to appeal an adverse determination under the terms of PHS regulations at 42 CFR Part 50, Subpart D, and DHHS regulations at 45 CFR Part 16. Business management aspects of these awards will be administered by the NICHD Grants Management Branch, NICHD, in accordance with DHHS and NIH grants administration requirements. 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," which have been published in the Federal Register of March 28, 1994 (FR 59-14508-14513) and the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. LETTER OF INTENT Prospective applicants are asked to submit, by August 1, 1997, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Donald McNellis Pregnancy and Perinatology Branch National Institute of Child Health and Human Development 6100 Bldg, Room 4B03 6100 Executive Blvd., MSC 7510 Bethesda, Maryland 20892-7510 Telephone: 301-496-5575 FAX: 301-496-3790 E-mail: dm88q@nih.gov APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: ASKNIH@odrockm1.od.nih.gov. The RFA label in form PHS 398 (rev. 5/95) must be affixed to the bottom of the face page of the original copy of the application. Failure to use this label could result in delayed processing of the application such that it will not reach the review committee in time for review. The title MFMU-DCC COOPERATIVE AGREEMENT and the RFA 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: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH ROCKLEDGE BUILDING, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the same time of submission, two additional copies of the application must be sent to: Division of Scientific Review National Institute of Child Health and Human Development Building 6100, Room 5E03 Bethesda, MD 20892 Rockville, MD 20852 (for express/courier service) Applications must be received by September 19, 1997. If an application is received after that date, it will be returned to the applicant without review. Schedule Letter of Intent Receipt Date: August 1, 1997 Application Receipt Date: September 19, 1997 Review by Advisory Council: January 1998 Anticipated Award Date: April 1, 1998 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by NICHD. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the Request for Applications 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, a process may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on their scientific merit relative to other applications received in response to the RFA. Applications determined to be non-competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. Those applications that are complete and responsive, will undergo further scientific merit review. Applications meeting the minimum requirements will be evaluated on scientific and technical merit according to the criteria listed below. o Qualifications, Experience, and Commitment of Key Personnel. Scientific and administrative abilities of the Principal Investigator and other team members; experience of the Principal Investigator and other key personnel in statistical,data management, quality control, study coordination, and administrative aspects. o Protocols and Procedures. Quality of past performance and proposed plans for: study coordination, data collection, analysis and monitoring; willingness to work cooperatively with other awardees and NICHD in the manner summarized in the Terms of Award. o Facilities and Management. Evidence of satisfactory facilities and supporting environment, including space and equipment for work proposed (any new equipment requested under this award must be adequately justified); evidence of institutional support for participation in a long term collaborative program. o Budget. Appropriateness of proposed budget in light of budget guidelines outlined in Appendix I. Adequacy of documentation of willingness to follow capitation of specific operational costs. o Appropriateness of Plans for Protection of Human and Animal Subjects and Compliance with NIH Policy on Inclusion of Women and Minorities. AWARD CRITERIA Applications recommended by the NICHD Council will be considered for award based primarily on scientific and technical merit. Programmatic priorities and availability of funds may also determine the award made. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Donald McNellis, M.D. Center for Research for Mothers and Children National Institute of Child Health and Human Development Building 6100, Room 4B03H Bethesda, MD 20892 Telephone: 301-496-5575 FAX: 301-496-3790 E-mail: dm88q@nih.gov Inquiries regarding grants management and administrative policy may be directed to: Mary Ellen Colvin Grants Management Branch National Institute of Child Health and Human Development Building 6100, Room 8A17 - MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-496-1303 FAX: 301-402-0915 E-mail: mc113b@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.3865. 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 PHS grant policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. Appendix I: At the time of application, a base budget will be required, and a description of a method to calculate operational costs will be required. The base budget will be one necessary to design protocols and to prepare to receive data entered from the three hypothetical protocols described in number eight, and in number 10, of the research plan outlines for incumbent (3a) and other (3b) applicants, respectively. In addition, other fixed DCC costs such as supplies and travel may be included, as outlined below. Personnel: Principal Investigator 100% Biostatistical staff 200% (with graduate degrees) Network Coordinator 100% Administrative Assistant 100% Supplies: $2,500 Travel: four trips for four staff to make site visits to clinical centers. Operational Costs: (No specific budget requested at time of application) Operational costs for the DCC are those costs incurred after the start of patient enrollment. They include: o Data entry, management, quality control o Report generation o Data analysis, manuscript preparation o Arrangement of logistical services for protocol-specific costs, including subcontracts, supplies o DCC resource management, subcontracting The methods to calculate these costs proposed by the applicant will be used as the basis for individualizing cost recovery for each protocol separately. Agreement will be reached by discussions between NICHD staff and the successful applicant. Periodic adjustment of these reimbursement arrangements will be made based on actual experience with each protocol. .
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