FDA Implementation of Manufacturing Volume Data Reporting Requirements under CARESAct Section 3112(e)

FDA执行CARES法案第3112(e)节对产量数据报告的要求

This communication is to clarify the timing of FDA's implementation of new reporting requirements for manufacturing volume data under section 3112(e) of the Coronavirus Aid, Relief, and Economic Security(CARES) Act. The effective date of these requirements -September 23, 2020, which is 180 days after the CARES Act was enacted - is the earliest the FDA is authorized to begin collecting these data. The FDA does notintend to begin this collection until it is able to do so through an electronic data submission portal, which will not be ready by September 23.

本通报旨在澄清FDA根据《冠状病毒援助、救济和经济安全（CARES）法案》第3112（e）节实施的有关产量数据的新报告要求的实施时间。这些要求的生效日期为2020年9月23日，即CARES法案颁布后的180天，这是授权FDA开始收集这些数据的最早日期。在能够通过电子数据提交门户网站进行收集之前，FDA并不打算开始收集，该门户网站将于9月23日准备就绪。

The CARES Act includes authorities that enhance FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing FDA’s visibility into drug supplychains. Specifically, section 3112(e) amends the Federal Food, Drug, and Cosmetic Act to require that each registered drug establishment annually reportthe “amount of each drug . . . that was manufactured, prepared, propagated, compounded, or processed” by the registrant for commercial distribution. This CARES Act amendment also provides that such “information may be required to be submitted in an electronic format."

CARES法令包括通过增强FDA对药品供应链的透视能力，授权FDA提高识别、预防和减轻可能的药品短缺的能力。具体来说，第3112（e）条修正了《联邦食品药品和化妆品法案》，要求每个注册药品机构每年报告 “由注册人生产、制备、宣传、配制或加工”用于商业销售的“每种药品的数量”。该CARES法修正案还规定，此类“信息可能需要以电子格式提交”。

FDA staff are working to define the data to be reported, create an electronic portal for the submission of this information, and determine when to begin collecting this information. We will provide further updates as our implementation planning continues.

FDA工作人员正在努力界定要报告的数据，创建用于提交此信息的电子端口，并确定何时开始收集此信息。随着我们的实施计划的继续，我们将提供进一步的更新。

法案该条款内容如下：

SEC. 3112. ADDITIONAL MANUFACTURER REPORTING REQUIREMENTS IN RESPONSE TO DRUG SHORTAGES. 响应药品短缺的其它生产商报告要求

......

(e) REPORTING REQUIREMENT.—Section 510(j) of the Federal Food, Drug, Cosmetic Act (21 U.S.C. 360(j)) is amended—

(1) by redesignating paragraphs (3) and (4) as paragraphs (4) and (5), respectively; and

(2) by inserting after paragraph (2) the following:

‘‘(3)(A) Each person who registers with the Secretary under this section with regard to a drug shall report annually to the Secretary on the amount of each drug listed under paragraph (1) that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution. Such information may be required to be submitted in an electronic format as determined by the Secretary. The Secretary may require that information required to be reported under this paragraph be submitted at the time a public health emergency is declared by the Secretary under section 319 of the Public Health Service Act.

‘‘(B) By order of the Secretary, certain biological products or categories of biological products regulated under section 351 of the Public Health Service Act may be exempt from some or all of the reporting requirements under subparagraph (A), if the Secretary determines that applying such reporting requirements to such biological products or categories of biological products is not necessary to protect the public health.’’.

（e）报告要求。联邦食品药品化妆品法案（21 USC 360（j））第510（j）条进行了修改，

（1）将第（3）和（4）款分别重新指定为第（4）款和（5）；

（2）在第（2）款之后插入以下内容：

“（3）（A）凡根据本部分与药品相关要求在FDA注册者，应每年向FDA报告每种根据段（1）所列药品由注册人所生产、制备、配制或加工用于商业化销售的数量。此类信息可能要按FDA决定以电子格式提交。FDA可根据本段要求在FDA根据《公共卫生服务法》第319条所规定宣布的公共卫生紧急状况期间报告所需信息。”

（B）根据FDA命令，如果FDA认为受《公共卫生服务法》第351条监管的特定的生物制品或生物制品类别不必执行此类要求即可保护公众健康时，可部分或全部豁免（A）段中的报告要求。

上述FEAR法案原文官方链接

https://www.congress.gov/116/plaws/publ136/PLAW-116publ136.pdf