Center for Scientific Review

Widi the above background in mind, NIGMS organized a meeting held on Ihe NIH canq)us in Bethesda, Maryland, June 28-29, 2000. The meeting was co-sponsored by the Center for Scientific Review, the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK), the National Institute of Environmental Health Sciences (NIEHS), and die Office of Dietary Supplements, Office of the Director, NIH. 

Guide For Assigned Reviewers Preliminary Comments On Research Grant Applications (ROl), Center for Scientific Review, National Institutes of Health. http //www.csr.nih.gov/CDG/CD%20Guidelines/r01. pdf... 

Alain Berthod received his PhD in 1979 from the University of Lyon. He took an assistant professor s position at the French National Center for Scientific Research (CNRS) working in electrochemistry. In 1983 he was promoted as associate professor and in 1993 as research director. He focused on the developing and the use of micellar solutions and microemulsions in chromatography. His interests lie in the separation of chiral molecules and enantiorecognition mechanisms. He has contributed to the development of the countercurrent chromatography technique that uses a sup-port-free liquid stationary phase. He was member of the editorial board of major analytical chemistry and chromatography journals. He is editor-in-chief of Separation Purification Reviews (Taylor Francis, Philadelphia, Pennsylvania). 

The authors acknowledge support from the EU training and research network NANOQUANT ( Understanding Nanomaterials from a Quantum Perspective , contract No. MRTN-CT-2003-506842), the Deutsche Forschungsgemeinschaft, the Fonds der Chemischen Industrie, the Danish Research Agency, and the Danish Center for Scientific Computing. Many thanks are also due to the long list of collaborators who contributed over many years to the work reviewed here. 

Once the FDA receive the initial submission, an IND reference number is assigned. The application is then passed on to the appropriate review centre either the Center for Drug Evaluation and Research (CDER), or the Center for Biologies Evaluation and Research (CBER). Various experts will then review the submitted documents, the purpose being to ensure that the safety of subjects is not compromised and, in the case of Phase II and III studies, that the quality of study design is scientifically adequate. The FDA are allowed 30 days to complete the initial review, after which the study can commence, provided that it has been approved by an Institutional Review Board (IRB). 

In June 1993, the Center for Devices and Radiological Health (CDRH) introduced tier/triage management initiatives to improve the efficiency of its administrative and scientific review of premarket applications. One key item in this plan was introduction of a tier/triage process for 510(k) applications. This proposal was designed to allow levels of 510(k) reviews adjusted according to the device risk. Three review levels were proposed as follows ... 

James N. Pitts, Jr., is a Research Chemist at the University of California, Irvine, and Professor Emeritus from the University of California, Riverside. He was Professor of Chemistry (1954-1988) and cofounder (1961) and Director of the Statewide Air Pollution Research Center (1970-1988) at the University of California, Riverside. His research has focused on the spectroscopy, kinetics, mechanisms, and photochemistry of species involved in a variety of homogeneous and heterogeneous atmospheric reactions, including those associated with the formation and fate of mutagenic and carcinogenic polycyclic aromatic compounds. He is the author or coauthor of more than 300 research publications and three books Atmospheric Chemistry Fundamentals and Experimental Techniques, Graduate School in the Sciences—Entrance, Survival and Careers, and Photochemistry. He has been coeditor of two series, Advances in Environmental Science and Technology and Advances in Photochemistry. He served on a number of panels in California, the United States, and internationally. These included several National Academy of Science panels and service as Chair of the State of California s Scientific Review Panel for Toxic Air Contaminants and as a member of the Scientific Advisory Committee on Acid Deposition. 

The Coimcil is made up of the members and the participants who serve on the scientific committees of the Council. The Council members who are selected solely on the basis of their scientific expertise are drawn from public and private universities, medical centers, national and private laboratories and industry. The scientific committees, composed of experts having detailed knowledge and competence in the particular area of the committee s interest, draft proposed recommendations. These are then submitted to the full membership of the Council for careful review and approval before being published. 

Product tests, methods and specifications Audit of the data submitted for CDER review in the application is a Field responsibility. CDER is responsible for the scientific review of the associated data and for the ultimate approval of the tests, methods, and specifications established for the drug product in the application. The Field will advise the center when it finds a questionable specification. 

The research described in this review was partially supported by Grant-in-Aid for Scientific Research on Priority Areas Chemistry of Coordination Space and a Grant-in-Aid for Science Research in a Priority Area Super-Hierarchical Structures from Ministry of Education, Science, Sports, and Culture, Japan World Premier International Research Center Initiative (WPI Initiative) on Materials Nanoarchitronics, from Ministry of Education, Science, Sports, and Culture, Japan and Grants-in-Aid for Scientific Research (B) from Japan Society for the Promotion of Science. 

The National Center for Drug Analysis in St. Louis, MO, was a constant, valued, and cooperative participant in the revision process for nearly 3 decades. This laboratory continued from past cycles to do extensive development and review of tests and assays. During this cycle, it continued as the primary FDA participant in the ongoing evaluation of established and proposed new USP Reference Standards. Moreover, careful review was given to many General Chapters and issues in harmonization. The FDA is the single most productive outside source of scientific data and information. 

The National Center for Toxicological Research (NCTR), a component of the Jefferson Laboratories of the Food and Drug Administration (FDA), is located in Jefferson, Arkansas. Its mission is to conduct innovative peer-reviewed scientific research focused on FDA regulatory needs. Research findings provide the basis for FDA to make sound science-based risk management decisions that promote the health of the American people. 

The US Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT) has only a 90-day review period to issue a decision on Premanufacture Notices filed under the TSCA for any new compound to be manufactured or imported. The availability of inexpensive approaches for reliable assessment of hazard to environment and human health could be of immense value to OPPT. Likewise agencies such as the European Center for the Validation of Alternative Methods (ECVAM) aim to promote the scientific and regulatory acceptance of alternative methods... which reduce, refine, or replace the use of laboratory animals [5]. 

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