Full Text HD-93-06 NETWORK OF PEDIATRIC PHARMACOLOGY RESEARCH UNITS NIH GUIDE, Volume 21, Number 40, November 6, 1992 RFA: HD-93-06 P.T. 34, AA Keywords: Pharmacology Children (Patients) Infants Adverse Effects National Institute of Child Health and Human Development Letter of Intent Receipt Date: February 15, 1993 Application Receipt Date: April 13, 1993 PURPOSE The National Institute of Child Health and Human Development (NICHD) plans to support a cooperative Network of Pediatric Pharmacology Research Units (PPRU) to serve as a resource for studies of drug action and disposition in infants and children. These studies will be conducted by pediatric clinical pharmacologists, either cooperatively with investigators at other units in the network, collaboratively with pharmaceutical companies, or independently with other support. The ultimate goal of studies conducted by the network is to provide the clinical data on drugs necessary for U.S. Food and Drug Administration (FDA) approval for use in children. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention goals of "Healthy People 2000," a PHS-led national activity for setting priorities. This Request for Applications (RFA), Network of Pediatric Pharmacology Research Units, is related to the priority areas of food and drug safety and maternal and infant health. Copies of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0, or Summary Report: Stock No. 017-001-00473-1) are available through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS PPRU cooperative clinical agreement (U01) awards will be made to children's hospitals or their equivalent or to educational institutions with accredited medical schools, within the United States. Each PPRU must become an identifiable unit within its institution, its Principal Investigator reporting to the chief of pediatrics or the chairperson of the pediatrics department. The applicant institution must also meet the standard eligibility requirements for research grants established in the Public Health Service Grants Policy Statement #(OASH) 90-50,000, Rev. 10/1/90. There must be at the applicant institution an ongoing program of excellence in clinical pharmacology, with an emphasis on pediatric applications. The quality of this program must be evident from the receipt by its staff of research support in peer-reviewed competition, or from their consistent record of publication in peer-reviewed research journals. In addition, the applicant institution must have available a sufficient number of eligible research subjects in the pediatric age groups: newborns, infants, children, pre-adolescents, and adolescents. This is an essential component of the network and must be spelled out in detail in the application. MECHANISM OF SUPPORT The funding mechanism to be used to assist the scientific community in undertaking this program of research in clinical pharmacology will be a cooperative clinical agreement (U10) between the participating units and the NICHD. The U10 award will provide support for laboratory and administrative resources to assist the research community in carrying out clinical therapeutic research protocols. The major difference between a cooperative agreement and a traditional research grant is the substantial scientific involvement of NICHD staff beyond the levels normally required for program stewardship of grants. Cooperative clinical agreements (U01) are assistance mechanisms and are subject to the same administrative requirements as grants. FUNDS AVAILABLE It is expected that up to four applications will be funded, within the total direct cost limit of $1,000,000 available for the first year. Therefore, the maximum direct cost request (first year) for individual applications should not exceed $250,000. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. 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 Background Federal law and the regulations of the FDA require that drugs be tested for safety and efficacy before they are approved for clinical use. This testing must take place in all populations in which the drug will be employed. Since both the qualitative and quantitative aspects of pharmacodynamics and pharmacokinetics are different in immature individuals, studies must be conducted in infants and children before a drug can be approved for use with them. For the purposes of this RFA, the term children is used to mean human beings during their prenatal and postnatal stages of development, from fetal life through adolescence. Several practical problems discourage the testing of drugs in children. These include the unforeseeable nature of some clinical responses in immature individuals; the possibility of catastrophic unanticipated reactions; the threat of effects on growth or health long after completion of the drug administration; the difficulty in predicting efficacious blood levels by extrapolation from data obtained in adults; the ethical problems of conducting nontherapeutic research in children; the awkwardness of procedures for obtaining informed consent or assent in older children; the lack of a suitable infrastructure for the conduct of pediatric pharmacology research; the high cost of pediatric studies; and the absence of a financial incentive for the pharmaceutical industry to conduct pediatric pharmaceutical trials if children are a minority of the population for which the drug might be prescribed. The result of these practical problems and the regulatory requirements is that more than three-quarters of the drugs marketed in the United States, including many of the most useful agents in modern therapy, are not approved as safe and effective for use in children. Since the provision of pediatric care without the use of these agents would be unacceptable, they are commonly administered "off-label" (without specific FDA approval) by pediatricians, anesthesiologists, general practitioners, surgeons, and others. Under these conditions the child is at risk of an inadequate therapeutic response or some unanticipated adverse reaction. Physicians can face medicolegal actions as a result of such accidents, but they can also risk suit for failure to utilize an effective drug for a child's illness, even if that drug does not have specific FDA approval for use in children. This dilemma must be resolved if children are to receive the full benefits of contemporary therapeutics. Modern pediatric pharmacology is a sophisticated clinical discipline capable of carrying out the studies necessary for the safe and ethical evaluation of drugs in children. Pursuit of such studies, however, is limited by the scarcity of available facilities in which to follow children receiving drugs and collect data in a systematic way, as well as the small number of qualified clinical investigators interested in this problem. In order to assist the pediatric community in carrying out these needed studies, the NICHD is issuing this RFA. Objectives and Scope The objective of the PPRU Program is to increase the number and variety of medications that are FDA-approved for use in children, with the ultimate goal that all drugs prescribed for children be labeled for such usage. This is to be accomplished by providing resources for pediatric pharmacokinetic and pharmacodynamic research through the establishment of a Network of Pediatric Pharmacology Research Units (PPRU). Each PPRU will have four specific aims: (1) To participate with other units in the network and with NICHD staff assistance in collaborative clinical trials of drugs in children through protocols determined by consensus; (2) To provide a locus for the conduct of pre-marketing and post-marketing clinical trials in children by qualified clinical pharmacologists working in collaboration with proprietary pharmaceutical firms; (3) To conduct independent, investigator-initiated studies on the pharmacodynamics and pharmacokinetics of drugs in children; and (4) To provide an environment in which pediatricians and others can gain supervised experience in pediatric clinical pharmacology. It is expected that most of the studies conducted in the PPRU network will be clinical and pediatric. Nevertheless, pre-clinical studies may sometimes be conducted (with other support) in a Unit's core laboratory if these are important as preliminaries or adjuncts to clinical projects. Similarly, limited clinical studies in adults may sometimes justify PPRU support if they are necessary for adapting existing protocols to children. Components of a PPRU A. Principal Investigator and Administrative Staff The Principal Investigator (PI) of a PPRU must be an established pediatric clinical pharmacologist, preferably holding independent peer-reviewed grant or contract support, actively publishing in the field, and familiar with academic and proprietary research in pharmacology and pharmacokinetics. The PI is responsible for developing and maintaining the PPRU as an institutional and national resource and for general oversight, appointing the members of the institutional advisory committee (see below) and (with advisory committee advice) the associate clinical pharmacologist and other members of the Unit staff. It is expected that the PI will be active in conducting research within the Unit and in negotiating support from proprietary pharmaceutical organizations. The PI will assist other investigators in conducting PPRU research protocols. The PI will attend the meetings of the Network Steering Committee (see below) and participate in its deliberations. The PI may be supported for up to 25 percent time and effort in the program, and may be assisted by a part-time secretary (25 percent time and effort). The PI is expected to hold final authority and responsibility for the care of PPRU patients, reporting only to the chief of pediatrics or the chairperson of the pediatrics department, even though the regular care of the patients may be in the hands of other investigators or house officers. The PI must therefore be state-licensed as a physician and board-certified in pediatrics. B. Local Advisory Committee This group will play an important part in the operations of the PPRU program. It should comprise from three to five members of the host institution faculty in addition to the PI, either users or non-users of the Unit, appointed for defined terms. Members should all be sensitive from experience or training to the special needs of children participating in research. They should all be qualified for the committee's principal activities, evaluating protocols to be conducted on the Unit for scientific merit and recommending to the PI priorities for the use of unit resources. The committee also has the responsibility of examining the qualifications of candidates for the associate clinical pharmacologist and other PPRU positions and reporting their recommendations to the PI. C. Clinical Facility A designated physical site where the clinical research is to be performed is required. To allow optimal opportunities for collaboration among units in the network, it is desirable that each PPRU have both an inpatient and an outpatient capability. These could be provided by a pediatric metabolic ward and outpatient clinic, a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources and suitable for admitting children and caring for them as outpatients, or some other unit similarly equipped for conducting pediatric clinical research. Applicant institutions that wish to identify the GCRC as a site for conducting PPRU research should include with the application a letter of agreement from the GCRC program director or PI. D. Core Laboratory A funded PPRU may include a core laboratory dedicated to performing specialized analyses and/or data management functions for studies conducted in the Unit. This should not include procedures routinely performed for a fee in institutional laboratories or available in the laboratories of the investigators utilizing the unit. Each proposed protocol should end with an estimate of staff time and required hospital ancillary costs that will be made necessary by pursuit of the protocol. (These costs should not be included in the overall requested Unit budget, since they will be distributed over all the network participants in that protocol.) For studies performed in collaboration with pharmaceutical firms, those firms should pay the fees for research-related clinical determinations. For investigator-initiated studies in which pharmaceutical firms do not participate, these costs must be supported from sources other than the PPRU funding. The core laboratory may be staffed by a PPRU-supported doctoral-level core laboratory director (maximum 25 percent time and effort) and a core laboratory technician (maximum 50 percent time and effort), if the science proposed so warrants. Core laboratory consumable expenses and equipment maintenance costs, up to a maximum of $20,000 annually, may be supported if justified. The core laboratory director, who reports to the PI, should have responsibility for quality control in that laboratory. The time and effort of the PI may also be devoted to developing new methods for protocols being conducted with PPRU support and to standardizing procedures to be carried out for PPRU network collaborative protocols. In addition, the core laboratory director is responsible for the care and maintenance of the laboratory equipment, and will cooperate with the PI in assisting other investigators in their use of the Unit. The equipment used in the core laboratory should be primarily that available to the investigators or obtainable from institutional resources. Nevertheless, new equipment up to a maximum cost of $50,000 over the first four years of the award may be requested in a PPRU cooperative agreement application, with appropriate justification. As an occasional courtesy, determinations that are available in the core laboratory may be performed for non-PPRU protocols, at the discretion of the PI and core laboratory director. For consistent or recurrent non-PPRU usage, or for drug company-initiated protocols being pursued on the units, there should be appropriate reimbursements from non-PPRU sources for core laboratory equipment maintenance, supplies, and personnel time, as well as for data management costs. These reimbursements, which must be used to offset unit costs, should be reported as grant-related income. E. Investigators Any person with pediatric privileges at the grantee institution is eligible to utilize the PPRU resources for studies of drug efficacy or metabolism, supported from independent research funds, if the protocols have been approved and prioritized by the local PPRU Advisory Committee. These individual investigator protocols must not delay or interfere with pursuit of the collaborative studies that are the Units primary responsibility. For investigators inexperienced in clinical pharmacology, the PI is expected to provide advice and guidance. Clinical pharmacists are encouraged to participate in PPRU research in collaboration with physicians who bear the responsibility for patient care. F. Research Plan The scientific program at each PPRU should comprise three areas of investigation. The first priority will be the collaborative protocols agreed upon by the Network Steering Committee (see below); the second will be protocols performed for and with pharmaceutical companies; and the third will be the Unit's own investigator-initiated research protocols. For the inter-PPRU collaborative work, applicant institutions are asked to provide one or two examples of drug evaluation studies that they would propose to the Network Steering Committee (see below). These examples should be drafts (up to 1,500 words) for consideration by other participants in the program, but should include enough detail (proposal, rationale, significance, procedures, resources required, end points, power calculations, and discussion of feasibility) to allow reviewers of the application to evaluate them for scientific merit. For the collaborative work with industry, each applicant may include one or two examples of previous studies conducted with pharmaceutical organizations on the development of drugs for use in children. Alternatively, a protocol proposed for pursuit with industry participation may be presented, if a letter of interest from the proprietary organization is included. For the independent investigator work, each PPRU application should include one or two examples of research protocols on pharmacokinetics or pharmacodynamics in children that participating investigators intend to pursue if the PPRU is funded. These protocols should be presented in fewer than 1,500 words. Each should include a clearly identified hypothesis, brief background information, and a narrative of the procedures to be employed. They should include details of statistical design and enough additional specific material as necessary for a fair scientific review. In addition, each protocol should provide a brief justification of its need for PPRU resources. G. Nurse Coordinator A qualified nurse coordinator is one of the most important assets of a PPRU. The nurse coordinator reports to and takes direction from the PI, whether or not he or she is a member of the institution's nursing service. The nurse coordinator (in cooperation with the associate clinical pharmacologist) carries out as many parts of the research protocols as possible, dovetailing schedules for maximum efficiency and instructing and supervising the other nursing staff in those operations or procedures for which he or she is unavailable. He or she is responsible for data collection and organization, unless the latter responsibility is assigned to a data coordinator (see below). One or more individuals may be supported in the nurse coordinator position, at a total of one full-time equivalent (100 percent time and effort). H. Associate Clinical Pharmacologist Units may request support for salaries and fringe benefits for this position (maximum 50 percent time and effort). The associate clinical pharmacologist may be a physician who is fully trained in pediatrics, has completed subspecialty training, and wishes to gain experience in the conduct of pediatric pharmacology research under the guidance and supervision of the PI or some other appropriate person. Alternatively, the associate clinical pharmacologist may be a non-physician holding the Pharm.D. degree who has had special training in pediatric pharmacology and wishes to obtain additional supervised clinical experience. Support for the associate clinical pharmacologist from the PPRU is for research time and effort only, except that if this person is a licensed physician he or she may assist the PI in supervising patient care in the Unit. A qualified individual may be supported for up to two years as an associate clinical pharmacologist at a PPRU. I. Data Coordinator Each PPRU application should include information about the data management system to be used in the unit. The system must be satisfactory not only for support of local PPRU activities, but also for participation in collaborative studies being performed by the network, since each PPRU will serve in turn as the data coordinating center for collaborative protocols. If justified by the volume of work expected, a data coordinator may be supported (up to 25 percent time and effort) by a PPRU grant. This person will organize the data in preparation for transmission to other PPRUs when appropriate. These functions are critical to the success of the network. SPECIAL REQUIREMENTS Terms and Conditions of Awards 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 at 45 CFR Part 74, and other HHS, PHS, and NIH grant administration policies and procedures. The specific terms and conditions pertaining to the nature and scope of the interaction between NICHD staff and the participating PPRUs will be incorporated into the Notice of Grant Award and will be in addition to the customary programmatic and financial negotiations that occur in the administration of grants. Awardee Responsibilities Each PI will have primary responsibility to define objectives and approaches and to plan, conduct, analyze, and publish results, interpretations, and conclusions of his/her studies. For network collaborative protocols, this responsibility will be shared with other network members and the project coordinator. The awardees retain custody of and primary rights to the data developed under those awards, subject to government rights of access, consistent with current HHS, PHS, and NIH policies. Awardees must be willing to participate and collaborate with other awardees and with NICHD staff. NICHD Responsibilities The Project Coordinator (Medical Officer, Endocrinology, Nutrition and Growth Branch, NICHD) will assist in the identification of important areas for study; in the development of collaborative protocols; in the review and evaluation of each stage of study protocols before subsequent stages are started; and in the reporting of results to the scientific community. Network Steering Committee Responsibilities The Network Steering Committee (NSC) will consist of the PIs of the funded units and the Project Coordinator, NICHD, and will be chaired by an (non-voting) outside chairperson selected by the members. The committee will meet at least quarterly to review and select protocols to be performed collaboratively by the network and to exchange information on progress. The Steering Committee will collaboratively establish rules governing publication, analysis and inter-unit sharing of data. Arbitration Procedures Whenever agreement between an awardee and NICHD staff cannot be reached on programmatic and scientific issues that arise after the award, an arbitration panel will be formed. The panel will consist of one person selected by the PI, one person selected by the NICHD Project Coordinator, and a third person selected by these two members. The decision of the arbitration panel, by majority vote, will be binding. These special arbitration procedures in no way affect the awardee's right to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16. Other Application Requirements A Safety Monitoring Committee will monitor the data from each ongoing collaborative clinical trial and advise on the safety of its continuation. This committee, to be selected by the Steering Committee, will include expertise in clinical trial design, pharmacology, epidemiology, statistics, and medical ethics. The availability of a pharmacy capable of supporting clinical research activities and experienced in the preparation of materials for randomized clinical trials should be documented. An explicit statement of the applicants' preparedness to participate in PPRU network clinical trials according to the terms of the RFA should be in the application, and evidence of a long-term institutional commitment to the needs of the PPRU is required. This may take various forms, including (but not limited to) the waiver of facility fees or bed costs for use of an outpatient clinic or research ward for patients on protocol; equipment and space for a core laboratory; released time for faculty to perform clinical pharmacology research in children; and/or funding for support personnel. Allowable Budgetary Items and Supportable Activities Allowable costs in NIH cooperative agreements are governed by rules set forth in the Public Health Service Grants Policy Statement and as stated on the Notice of Grant Award. Under these rules the PI may exercise flexibility to meet unexpected requirements by rebudgeting or requesting approval to rebudget among categories within the total direct cost budget of the PPRU (as shown on the Notice of Grant Award), within the ceilings set in these guidelines. PPU grants are for five years, at a maximum level of $250,000 in direct costs for the first year, with annual increments of 4 percent thereafter. They are renewable through competing continuation applications, provided funds are available. Items supportable through a PPRU cooperative agreement award may include: 1. Administration. Personnel: Principal investigator (maximum 25 percent time and effort); secretary (maximum 25 percent time and effort). Administrative Support Services: supplies, duplication costs, telephone. Travel: PI to meetings of the NSC. 2. Core Laboratory. Personnel: Core laboratory director (maximum 25 percent time and effort); core laboratory technician (maximum 50 percent time and effort). Equipment: Maximum of $50,000 total cost, distributed over the first four years of the award. Supplies: Appropriate for unit participation in collaborative protocols and for support of specialized analyses for investigator-initiated studies on the Unit Other: Maintenance costs on equipment purchased by the award or otherwise dedicated to Unit use. The maximum allowable total annual amount for supplies plus other in the core laboratory is $20,000. 3. Research Services Core. Personnel: Nurse Coordinator (maximum 100 percent time and effort); Associate Clinical Pharmacologist (maximum 50 percent time and effort); Data Coordinator (maximum 25 percent time and effort). The following items are not fundable through a PPRU grant: Costs of clinical care, such as patient bed costs, outpatient visit fees, and clinical laboratory determinations. These costs must be paid by the pharmaceutical companies for protocols performed on their initiative or by third-party carriers or other sources for investigator-initiated protocols. For Network protocols for which necessary ancillary costs cannot be paid from other sources, the NICHD will provide administrative supplements. Travel to scientific meetings or for any other purpose except for the PI to attend meetings of the NSC. Laboratory costs (outside the core laboratory) for projects being performed by investigators using the Unit. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF FEMALES AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and females in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study. Special emphasis must be placed on the need for inclusion of minorities and females in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If females or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. The composition of the proposed study population must be described in terms of gender or racial/ethnic group, together with a rationale for its choice. In addition, gender and racial/ethnic issues must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 in Sections 1-4 of the Research Plan and summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans [including American Indians or Alaskan Natives], Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of females or minorities in a study design is inadequate to answer the scientific question(s) addressed and the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and reflected in assigning the priority score to the application. All applications for clinical research support submitted to NIH are required to address these policies. NIH funding components will not award cooperative agreements that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit, by February 15, 1993, 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 subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows NICHD staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Ephraim Y. Levin, M.D. Endocrinology, Nutrition and Growth Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development Executive Plaza North, Room 637 Bethesda, MD 20892 Telephone: (301) 496-5593 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 9/91) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. 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 2a of the face page of the application form and the YES box must be marked. Applicants should follow the instructions included with PHS Form 398 except where these are at variance with instructions in this RFA. Since the generic guidelines were not prepared specifically to be used for PPRU cooperative agreement applications, considerable flexibility in application format will be tolerated. Applicants should take care, however, that adequate information is provided to allow reviewers to evaluate the application on the basis of the review criteria listed below. Since applicants will be proposing at least two research plans, the individual and the collaborative, the standard 25-page limit will not apply. For questions related to application format, applicants may contact one of the individuals under INQUIRIES. 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 Room 240, Westwood Building Bethesda, MD 20892** In addition to the application and copies mailed to the Division of Research Grants, two copies of the application must also be sent to: Susan Streufert, Ph.D. National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 5E01 Bethesda, MD 20892 Applications must be received by April 13, 1993. If an application is received after that date, it will be returned to the applicant. REVIEW CONSIDERATIONS Applications will be reviewed by the Division of Research Grants for completeness and by NICHD staff for responsiveness to the RFA. An incomplete or non-responsive application will be returned to the applicant. Responsive applications may be subjected to a triage by a peer-review group to determine the scientific merit relative to the other applications received in response to this RFA. The NICHD will withdraw from competition those applications judged to be noncompetitive and notify the applicants and institutional business officials. Applications considered responsive to this RFA will be reviewed for technical merit by an Initial Review Group convened by the scientific review staff of the NICHD solely to evaluate these applications. Criteria for the initial review are described below. Following review by the Initial Review Group, applications will be evaluated by the National Advisory Child Health and Human Development (NACHHD) Council for program relevance and policy issues before awards are made. REVIEW CRITERIA The following are the review criteria for the evaluation of PPRU applications: Qualifications of the core of experienced investigators in clinical pharmacology who have independent competitively-earned research support, a record of research productivity, and a demonstrated interest in pharmacological research in children. An explicitly stated willingness by these investigators to generate protocols to perform on the unit, propose protocols to the NSC for collaborative pursuit, and collaborate with pharmaceutical firms in testing useful drugs in children is required. Suitability of the proposed clinical locus for the Unit in the applicant institution or its affiliated hospital, such as a pediatric metabolic ward and outpatient clinic, a GCRC with staff accustomed to conducting studies in children, or some unit similarly staffed and equipped. Availability of a suitable population to participate as research subjects in PPRU studies. Qualifications of the PI for the duties described in this RFA. Scientific quality and relevance of the sample protocols proposed for pursuit in the Network and in the local PPRU. Evidence of previous successful research collaborations with industry or of efforts to arrange future collaborations. Nature, facilities, functions, and probable value to the research of any proposed core laboratory. Adequacy of data management resources available to support PPRU protocols. Evidence of institutional commitment to the long-term activities of the PPRU network. Composition of the proposed local advisory committee and its proposed procedures for evaluating protocols, monitoring ongoing research on the Unit, and recommending candidates for the associate clinical pharmacologist and other PPRU positions. Qualifications of the nurse coordinator proposed for support from the Unit and/or the criteria to be used in selecting a person for this position. Qualifications of the associate clinical pharmacologist (if any) proposed for support from the Unit and/or the criteria to be used in selecting a person for this position. AWARD CRITERIA The anticipated date of award is September 30, 1993. Awards will be made on scientific merit as determined by peer review. The availability of appropriate study populations, the extent of investigator experience, adequacy of equipment and facilities, and program balance will also be taken into account. Timetable Letter of Intent Receipt Date: February 15, 1993 Application Receipt Date: April 13, 1993 Initial Review Date: July 1993 Review by NACHHD Council: September 1993 Earliest Possible Award Date: September 30, 1993 INQUIRIES Written and telephone 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: Ephraim Y. Levin, M.D. Endocrinology, Nutrition and Growth Branch Center for Research for Mothers and Children National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 637 Bethesda, MD 20892 Telephone: (301) 496-5593 Direct inquiries regarding fiscal matters to: E. Douglas Shawver Supervisory Grants Management Specialist Office of Grants and Contracts National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 505 Bethesda, MD 20892 Telephone: (301) 496-1303 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.865, Research for Mothers and Children. Awards are made under authorization of the Public Health Service Act, Section 301 (42 USC 421), and administered under PHS grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Health Systems Agency review. .
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