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TABLE OF CONTENTS BACKGROUND 2DEVELOPMENT PROGRAM . 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, 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 TABLE OF CONTENTS BACKGROUND ............................................................................................................... 3LOGISTICAL AND TECHNICAL CONSIDERATIONS .................. Draft - Not for Implementation 2 Preface 38 39 40 Additional Copies 41 42 CDRH 43 Additional copies are available from the Internet . You may also send an e - mail request to 44 CDRH - Guidance@fd TABLE OF CONTENTS INTRODUCTION.............................................................................................................1BACKGROUND.................................................. Contains Nonbinding Recommendations 1 Information Sheet Guidance For IRBs, Clinical Investigators, and SponsorsThis guidance represents the Food and Drug Administration's (FDA's) current thinking , 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 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 For further information or questions, please contact Office of Inspector General Public Affairs at: DHS-OIG.OfficePublicAffairs@oig.dhs.gov Follow us on Twitter at: @dhsoig. To report fraud, waste, o For further information or questions please contact Office of Inspector General Public Affairs at DHS-OIGOfficePublicAffairsoigdhsgovFollow us on Twitter at dhsoig To report fraud waste or abuse visit