Fed Regist. 2017 May 19;82(96):22893-5.
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the "340B Drug Pricing Program" or the "340B Program." HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. In accordance with a January 20, 2017, memorandum from the Assistant to the President and Chief of Staff, entitled "Regulatory Freeze Pending Review," HRSA issued an interim final rule that delayed the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. HHS invited commenters to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate. After consideration of the comments received on the interim final rule, HHS is delaying the effective date of the January 5, 2017 final rule, to October 1, 2017.
卫生资源与服务管理局（HRSA）负责管理《公共卫生服务法》（PHSA）第340B条，即“340B药品定价计划”或“340B计划”。HRSA于2017年1月5日发布了一项最终规则，规定了最高限价的计算方法和民事罚款的适用。该最终规则适用于所有根据340B计划要求向受保实体提供药品的药品制造商。根据2017年1月20日总统助理兼办公厅主任题为“监管冻结待审查”的备忘录，HRSA发布了一项临时最终规则，将在《联邦公报》（2017年1月5日，第82卷，第1210页）上公布的最终规则的生效日期推迟至2017年5月22日。美国卫生与公众服务部（HHS）邀请评论者就是否将生效日期进一步推迟至2017年10月1日是否更合适发表意见。在考虑了对临时最终规则收到的评论后，HHS将2017年1月5日最终规则的生效日期推迟至2017年10月1日。
