Dear Mr. Feng:
On November 5, 2021, based on your1 request the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of the iHealth COVID-19 Antigen Rapid Test, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21U.S.C. §360bbb-3) for the indication stated in the letter.
Contracts For Jan. 14, 2022
iHealth Labs Inc., Sunnyvale, California, was awarded a $1,275,000,000 firm-fixed-price contract for COVID-19 rapid antigen tests. Bids were solicited via the internet with 20 received. Work will be performed in Sunnyvale, California, with an estimated completion date of March 14, 2022. American Rescue Plan Act funds awarded in 2022 in the amount of $1,275,000,000 were obligated at the time of the award. U.S. Army Contracting Command, Aberdeen Proving Ground, Maryland, is the contracting activity (W58P05-22-C-0009). (Awarded Jan. 13, 2022)
加利福尼亚州桑尼维尔的 iHealth Labs Inc. 获得了一份价值 1,275,000,000 美元的固定价格合同,用于 COVID-19 快速抗原检测。投标是通过互联网征集的,共收到 20 份。工作将在加利福尼亚州的桑尼维尔进行,预计完成日期为 2022 年 3 月 14 日。2022 年授予的美国救援计划法案资金 1,275,000,000 美元在授予时已到位。美国陆军承包司令部,马里兰州阿伯丁试验场,是合同订立方 (W58P05-22-C-0009)。(2022 年 1 月 13 日授予)