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Contains Nonbinding Recommendations 1 Information Sheet Guidance For IRBs Clinical Investigators and SponsorsThis guidance represents the Food and Drug Administrations FDAs current thinking. fdagovCosmeticGuidances You may submit written comments regarding th is guidance at any time Submit written comments on the guidance to the Division of Dockets Management H FA305 Food and Drug Administration 5630 Fishers La ne rm 1061 Rockville MD 20 fdagovScienceResearchSpecialTopicsRunningClinicalTrialsGuidancesInformationSh eetsandNoticesdefaulthtm US Department of Health and Human Services Food and Drug Administration June 2010 Procedural brPage 2br Contains Nonbinding Recommendations Informa TABLE OF CONTENTS BACKGROUND ............................................................................................................... 2MEETING TYPES ............................................ Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 51, rm Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Av Technical, Cost, and Requirements Issues and Evaluation barrel life is significantly reduced. To mitigate the deleterious effects of cased telescoped ammunition on barrel life, cartridge designs have Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale B TABLE OF CONTENTS BACKGROUND ............................................................................................................... 3LOGISTICAL AND TECHNICAL CONSIDERATIONS .................. Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale B Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 51, rm Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 51, rm Additional copies are available from: Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Bldg. 51, rm , or from the Internet at nces/default.htm For questions on the content of this guidance, contact OCOD at the phone numbers listed above. Center for Biologics Evaluation and Research Contains Nonbin Draft