FDA发布提议规定—按照动物种类收集抗生素销售和分销信息

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FDA Releases Proposed Rule to Collect Antimicrobial Salesand Distribution Information by Animal Species

FDA发布提议规定—按照动物种类收集抗生素销售和分销信息

May 19, 2015

2015年05月19日

The U.S. Food and Drug Administration is proposing revisions to its annualreporting requirements for drug sponsors of all antimicrobials sold ordistributed for use in food-producing animals in order to obtain estimates ofsales by major food-producing species (cattle, swine, chickens, and turkeys).The additional data would improve understanding about how antimicrobials aresold or distributed for use in major food-producing species and help the FDAfurther target its efforts to ensure judicious use of medically importantantimicrobials.

为了获取主要食品动物（牛、猪、鸡和火鸡）的抗生素销售和消费量，美国FDA正提议修改用于食品动物的抗生素药品销售或分销的赞助人的年报要求。这些额外的信息将增进对抗生素在主要食品动物中销售和分布的理解，并帮助FDA进一步有得放矢的确保合理使用医学上重要的抗生素。

The proposed rule also includes a provision to improve the timeliness ofthe report by requiring the FDA publish its annual summary report ofantimicrobial sales and distribution information by December 31 of thefollowing year.

提议的规定也包括提高报告的及时性规定，通过要求FDA在次年的12月31日之前公布每年的抗生素销售和分销信息的总结报告。

Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105)requires antimicrobial drug sponsors to report to the FDA on an annual basisthe amount of all antimicrobial drugs they sell or distribute for use infood-producing animals, including those antibiotics not used in human medicine.ADUFA 105 also requires the FDA to prepare summary reports of sales anddistribution information received from drug sponsors each year, byantimicrobial class for classes with three or more distinct sponsors,and to provide those summaries to the public.

《2008兽药用户收费修正案》105节要求抗生素赞助商向FDA报告每年的用于食品动物的所有抗生素药品的销售量，包括那些未被作为人用药的抗生素。《2008兽药用户收费修正案》105节也要求FDA通过从不同种类抗生素的三个或者更多不同的赞助商收集的销售和分销信息，并按照抗生素类别制定每年的销售总结报告，同时向公众提供总结报告。

Current regulatory authority limits the data collection that FDA can mandateto antimicrobial sales and distribution information. While addingspecies-specific information will help provide a fuller picture, more detailedinformation is needed about on-farm use practices to adequately understandlinks between usage patterns and trends in resistance. FDA is actively engagedwith the U.S. Department of Agriculture, Centers for Disease Control andPrevention, and a wide array of stakeholders to fill this need.

现行的管理部门虽限制了FDA对抗生素销售和分销信息的数据收集，但是增加具体动物的信息能帮助更进一步认识，更多关于农场终端使用实践的具体信息需被获知以充分了解药品使用方式和抗药性趋势之间的关系。FDA正积极的美国农业局，疾病控制和预防中心和广大的利益方接洽以满足该需求。

The FDA is accepting public comments on this proposed rule beginning onMay 20, 2015. To submit your comments electronically to the docket, go to www.regulations.gov and type FDA-2012-N-0447 in thesearch box. Please note that the docket will not be open to accept commentsuntil this date. The comment period will close 90 days after it publishes inthe Federal Register. While comments are welcome at any time, you should submitthem by the closing date for the FDA to consider your comments in drafting thefinal rule.

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To submit your comments to the docket by mail, use the following address.Be sure to include docket number FDA-2012-N-0447 on each page of your writtencomments.

The Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

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