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[联邦登记册78，第36号（2013年2月22日星期五）] [通知] [第12369-12372] ======================================================================= -----------------------------------------------------------------------------------------科技政策办公室美国政府政策制度监督生命科学的制度监督双重使用研究令人担忧的机构：科技政策办公室（OSTP）．行动：注意;请求评论。-----------------------------------------------------------------------------------------美国政府（USG）邀请对提议的评论美国政府的制度监督生命科学的政策双利用对关注的研究．拟议的政策规定了接受联邦资助的机构对某些类别的生命科学研究的机构审查和监督要求。这些要求旨在解决在现有联邦法规或指南中没有解决的双重用途研究的风险。遵守本政策的要求将由联邦资助机构根据其相关法定当局纳入联邦资助机构，进入奖项的条款和条件，该资助机构进行落入政策中确定的类别的研究。通过本通知提供的公众意见将为未来的审议和最终政策的发布提供信息。日期：发布日期：2013年2月22日。响应日期：2013年4月23日。地址：评论可以以电子方式提交给：durcpolicy@ostp.gov。评论也可以邮寄给：Franca R. Jones博士，助理总监 - 化学和生物对策，办公室[[第12370]]科技政策，艾森霍尔行政办公楼，1650年宾夕法尼亚大道，华盛顿特区，DC 20504。有关提交评论的具体信息，请参阅补充信息。拟议的政策可在美国卫生和人类服务科学安全安全部门（S3）网站：http://www.phe.gov/s3/dualuse/pages/default.aspx.．更多信息请联系:Dr. Franca R. Jones，科学技术政策办公室化学和生物对策助理主任，艾森豪威尔行政大楼，1650 Pennsylvania Avenue, Washington, DC 20504, durcpolicy@ostp.gov。补充资料:背景美国政府(USG)请对提议提出意见美国政府的制度监督生命科学的政策双利用对关注的研究．拟议的政策规定了接受联邦资助的机构对某些类别的生命科学研究的机构审查和监督要求。这些要求旨在解决在现有联邦法规或指南中没有解决的双重用途研究的风险。本政策的遵守要求，一旦最终确定，将由联邦资助机构根据其相关法定权限，纳入资助机构的奖励条款和条件(参见适用性，第6.1节)进行的研究属于政策中确定的类别(见范围，第6.2节)。通过本通知提供的公众意见将为未来的审议和最终政策的发布提供信息。生命科学研究对于科学进步至关重要，而科学进步是改善公众、农作物和其他植物、动物、环境、材料和国家安全的基础。生命科学研究已经并将继续产生效益，但没有一项生命科学研究是没有风险的。确实，为合法目的而进行的某些类型的研究也可能被用于有害的目的。这种研究被称为“双重用途研究”。'' Dual use research of concern (DURC) is a smaller subset of dual use research defined as life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. --------------------------------------------------------------------------- \1\ Materiel includes food, water, equipment, supplies, or material of any kind. --------------------------------------------------------------------------- In general, there are risks associated with life sciences research, such as accidental exposure of personnel or the environment to a pathogen or toxin. Many existing and synergistic statutes, regulations, and guidelines are in place to address risks associated with biosafety, physical security, and personnel reliability.\2\ Some risks relate directly to the characteristics of DURC--the risk that knowledge, information, products, or technologies resulting from the research could be used in a manner that results in harm or threatens society. DURC should be evaluated for possible risks, as well as benefits, in all these domains to ensure that risks are appropriately managed and benefits realized. This proposed Policy addresses dual use research risks holistically, that is, the risk that knowledge, information, products, or technologies generated from life sciences research could be used in a manner that results in harm. --------------------------------------------------------------------------- \2\ e.g. Select Agents and Toxins Program (42 CFR part 73, 9 CFR part 121, and 7 CFR part 331); National Institutes of Health Guidelines on Research Involving Recombinant DNA Molecules (http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.pdf）;微生物和生物医学实验室生物安全5辑（http://www.cdc.gov/biosafety/金博宝更改账户publications/bmbl5/bmbl.pdf.).-------------------------------------------------------------鉴于这些双重用途风险，美国政府于2012年3月29日发布了《关注的生命科学双重用途研究监督政策》（3月29日政策）。3月29日的政策正式规定了联邦政府定期审查美国政府资助或开展的某些高后果病原体和毒素研究的程序，以确定DURC并在适用的情况下实施缓解措施。3月29日政策的目标是保护生命科学研究的利益，同时最大限度地降低此类研究产生的知识、信息、产品或技术可能被用于造成伤害的风险。生命科学研究的资助者以及接受这些资助的机构和科学家共同负责监督DURC，并促进此类研究的负责任行为和交流。此处提出的政策，即美国政府关注的生命科学两用研究机构监督政策，涉及DURC的机构监督，并将与3月29日要求联邦机构实施类似措施以监督DURC的政策相一致。监督包括制定政策、实践和程序，以确保识别DURC，并在适当情况下实施风险缓解措施。DURC的机构监督是综合监督系统的一个关键组成部分，因为机构最熟悉在其设施中进行的生命科学研究，并且最有能力促进和加强DURC负责任的行为和沟通。该拟议政策规定了DURC的监督程序以及主要调查人员、研究机构和美国政府的责任。除了3月29日的政策外，该拟议政策还强调责任文化，提醒所有相关方共同承担维护科学完整性和防止其滥用的责任。\3\3 3月29日政策和本政策中概述的内容一旦最终确定，将根据需要进行更新，在国内对话、国际参与和相关社区（包括科学家、国家安全官员和全球卫生专家）的投入之后\3.《3月29日政策》和本拟议政策得到了其他现有法律和条约（如《美国法典》第18卷第175节和《生物和毒素武器公约》）的补充，这些法律和条约禁止发展、生产、获取或储存没有预防理由的种类和数量的生物制剂或毒素，保护性或其他和平目的，禁止使用生物制剂和毒素作为武器。---------------------------------------------------------------------------------------由于DURC的机构监督将是许多机构的一项新任务，因此美国政府目前将该拟议政策以及3月29日政策中的要求限制在符合第6.2节范围的研究上，它专注于生命科学研究的一个定义明确的子集，涉及15种药剂和毒素以及七类实验。美国政府将征求各机构在执行该政策方面的经验反馈；将评估DURC监督对生命科学研究企业的影响；将评估扩大政策范围以包括其他药剂和毒素和/或实验类别的益处和风险；并将根据需要更新政策。鼓励研究机构[[第12371页]]注意，本拟议政策所述类别之外的研究也可能构成DURC。机构有权考虑其他类别的研究DRC潜力，并可能扩大他们的监督，以其他类型的生命科学研究，因为他们认为合适的。最后，也是重要的一点是，符合DURC定义的研究通常会增加我们对病原体生物学的理解，并为开发新的治疗和诊断方法、改进公共卫生监督以及加强应急准备和响应工作做出重要贡献。因此，将研究指定为DURC不应被视为负面分类，而只是表明该研究可能需要额外的监督，以降低所产生的知识、信息、产品或技术可能以导致伤害的方式使用的风险。一般而言，将研究指定为DURC并不意味着不应进行或传达研究。本拟议政策中的任何内容均不得取代卫生与公共服务部和美国农业部的选择剂和毒素Program's (SAP) statutory authority or SAP regulations as published in 42 CFR part 73, 9 CFR part 121, and 7 CFR part 331. Specific Questions Public comments are sought on the entirety of the proposed United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. In addition, we are seeking input on the following specific questions: 1. For institutions conducting research that involves one or more of the 15 listed agents, please describe the feasibility and anticipated burden (administrative, resources, etc.), if any, to implement the requirements of this proposed Policy. What effect, if any, do you anticipate the proposed Policy would have on your ability to support or engage in research on any of the listed pathogens or toxins? 2. Are there alternatives to the administrative requirements of this proposed Policy that could be more easily implemented by Federally-funded research institutions and that would meet the intent of this proposed Policy or the March 29 Policy? If so, please specify. 3. How could DURC oversight be usefully integrated with other existing institutional oversight processes in order to reduce duplication and any resulting excess administrative burdens on institutions? 4. For institutions who have registered an Institutional Biosafety Committee (IBC) with the NIH Office of Biotechnology Activities in accordance with the NIH Guidelines for Research Involving Recombinant DNA Molecules, is it feasible for the IBC to conduct the DURC institutional review process? What are the benefits or limitations of using IBCs in this role? 5. Should research that has undergone institutional DURC review but has been determined not to be DURC be monitored for emerging DURC issues? If so, how often should such review take place? 6. Is it feasible for a single individual, the Institutional Contact for Dual Use Research (ICDUR), to be the point of contact for all dual use research-related questions to and from the funding agency? If not, who else could help fill this role? 7. The proposed Policy calls for principal investigators (PIs) to refer any research involving one or more of the 15 listed agents to an institutional dual use research review entity (Section 7.1.A). The institutional review entity will then determine whether the research can be reasonably anticipated to produce any of the seven effects, and if so, if that research meets the definition of DURC. Is it preferable to instead require PIs to determine both whether their research involves one or more of the listed agents and also whether their research can be reasonably anticipated to produce any of the listed effects? In this scenario, the institutional dual use research review entity would then only determine whether the research meets the definition of DURC. (Note: In either scenario, the institutional dual use research review entity would also then assess the risks and benefits of the research and develop a risk management plan.) 8. Is additional guidance or explanation needed for interpreting the seven effects/categories of experiments listed in Section 6.2.2? 9. The USG is developing a document that contains the following analytic tools and guidance to assist in implementation of the Policy, once finalized: a. Understanding and identification of DURC b. Assessment of risks and benefits associated with DURC c. Developing a risk mitigation plan for DURC d. Responsibly communicating DURC e. Training and education on DURC Are there any additional tools or guidance documents that would be useful in implementing and complying with this Policy, once finalized? 10. We are interested in views on the optimum relationship between the March 29 Policy and this proposed Policy. Are there any conflicts or challenges posed by implementing both policies? Should research institutions review projects for DURC issues prior to proposals being submitted to a funding agency for review? (If not, funding agencies implementing the March 29 Policy will not have the benefit of input from institutional dual use review when reviewing research proposals for DURC.) If so, should the PI and/or institution designate on the grant application that such a review has taken place and indicate its findings? 11. This proposed Policy is intended to apply to projects that directly use non-attenuated forms of the 15 agents or toxins listed in Section 6.2.1 and/or use botulinum toxin at any quantity. Should the scope also include (please provide information to support your answer): a. The use of any of the listed 15 agents or toxins in attenuated forms; b. The use of the genes from any of the listed 15 agents or toxins (all genes? Only certain types of genetic information? If the latter, how could this be specified?); c. In silico experiments (e.g. modeling experiments, bioinformatics approaches) involving the biology of the listed 15 agents or toxins; d. Research related to the public, animal, and agricultural health impact of any of the 15 listed agents or toxins (e.g. modeling the effects of a toxin, developing new methods to deliver a vaccine, developing surveillance mechanisms for a listed agent)? 12. Is the scope of the proposed Policy appropriate? If not, why not? Should the scope be expanded to all select agents, microbes, or all life sciences? If so, why? What factors should be considered in determining the final scope of oversight? What criteria might be used to determine what research should/should not be subject to oversight? If the Policy, once finalized, were expanded to cover other types of life sciences research (i.e. beyond the 15 listed agents), what effect, if any, would it have on your ability to conduct that research? 13. The USG recognizes that there may be some institutions that choose to expand their oversight beyond the 15 agents listed in Section 6.2.1 and/or beyond the seven categories listed in Section 6.2.2 or currently have a DURC oversight process in place that is beyond the scope of this proposed Policy. For [[Page 12372]] those institutions, what additional agents or toxins, other categories of experiments, and/or other domains within the life sciences were considered for potential oversight? What impact has the expanded oversight had on the conduct and administration of the institution's life sciences research? 14. The USG recognizes that there will be situations where a PI is conducting potential DURC at multiple institutions. Should each institution have oversight of these projects and if DURC is being conducted at their institution, develop and implement risk mitigation plans? Or should the PI's primary institution have this responsibility? (Refer to ``Note'' following Section 7.2.K) 15. The proposed Policy requires institutions that would be subject to the proposed Policy by virtue of Federal funding, to apply the proposed Policy to non-Federally funded research. Under the proposal, institutions would submit information about DURC reviews and risk mitigation plans on non-Federally funded projects to the National Institutes of Health (which may in turn refer the results and plans to the appropriate Federal agency based upon the nature of the research). Applying the DURC policy to Federally and non-Federally funded research promotes more meaningful oversight of DURC at the institutional level and fosters uniform approaches to the responsible conduct and communication of all research that may raise DURC concerns at an institution. Is this approach feasible? If not, what is the best mechanism for structuring oversight for non-Federally funded research? 16. The proposed Policy requires institutions to maintain records of DURC reviews, risk mitigation plans, and personnel training for three years. However, grant cycles are often longer than three years and DURC communications may arise even after funding has ended. This could result in situations where important records (e.g., the risk mitigation plan) are not available at the institution for certain DURC projects. Should the record-keeping requirements for this proposed Policy be longer to allow access to records over (and beyond) the lifetime of a DURC project? What is an appropriate amount of time that institutions should be required to retain such records? Availability of the Proposed Policy The proposed Policy is available on the U.S. Department of Health and Human Services Science Safety Security (S3) Web site:http://www.phe.gov/s3/dualuse/pages/default.aspx.．评论提交评论可以以电子方式提交给：durcpolicy@ostp.gov。也可以邮寄评论：Franca R. Jones博士，助理总监 - 化学和生物对策，科技政策办公室，艾森霍尔行政办公楼，1650年宾夕法尼亚Avenue华盛顿特区，直流20504。在您的回复中，请提供以下信息：日期名称/电子邮件/电话号码隶属关系/组织城市，国家一般意见评论对补充资料中列出的特定问题（1-16）如下：评论1质疑问题2对问题3评论3问题3评论第4问题评论第5条评论问题6问题7评论问题8评论问题9对问题10评论提出评论第11条评论问题11问题12对问题13评论第13题评论14问题14问题15对问题十字评论第16条评论你将提出评论收到确认收到您的回复的电子确认，但不会收到关于任何建议的个性化反馈。没有索赔对美国政府的索赔是由对该评论请求的回应而产生的，或者从政府使用这些信息的答复。副职员德德瓦勒。[fr doc。2013-04127提交了2-21-13; 8:45 am] BILLING CODE 3270-F3-P