Sec. 2. Definitions
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In this Act: The term associated medical supplies means any product necessary for the development and administration of COVID–19 diagnostic tests, including chemical reagents, test swabs, and personal protective equipment (including surgical masks, surgical gowns, face shields, gloves, and N95 masks). The term COVID–19 diagnostic test means a test— that is an in vitro diagnostic product (as defined in section 809.3 of title 21, Code of Federal Regulations, or any successor thereto) for the detection of SARS–CoV–2 or the diagnosis of COVID–19; and the administration of which— is approved, cleared, or authorized under section 510(k), 513, 515, or 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(k) , 360c, 360e, 360bbb–3); or the developer has received an emergency use authorization under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ), unless and until the emergency use authorization request under such section 564.
The term COVID–19 pandemic means the period beginning on the date that the public health emergency with respect to COVID–19 took effect, and ending on the date that is 6 months after the date on which the public health emergency declaration with respect to COVID–19 terminates. Except as otherwise provided, the term Indian Tribe has the meaning given the term Indian tribe in section 4 of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304 ). The term public health emergency with respect to COVID–19 means the public health emergency declared by the Secretary under section 319 of the Public Health Service Act ( 21 U.S.C. 247d ) on January 31, 2020, with respect to COVID–19.
The term Secretary means the Secretary of Health and Human Services. Except as otherwise provided, the term Tribal organization has the meaning given the term tribal organization in section 4 of the Indian Self-Determination and Education Assistance Act ( 25 U.S.C. 5304 ). The term urban Indian organization has the meaning given the term in section 4 of the Indian Health Care Improvement Act ( 25 U.S.C. 1603 ).
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- 21 USC 360bbb–3
- 21 USC 247d
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