Sec. 3. Federal manufacturing of COVID–19 diagnostic tests
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As soon as practicable after the date of enactment of this Act, but no later than 15 days after such date of enactment, the Secretary shall begin the process of manufacturing, or contracting with entities for the manufacture of, COVID–19 diagnostic tests and associated medical supplies, with a particular focus on extraction-free highly sensitive molecular tests, pooled highly sensitive molecular tests, low-cost rapid antigen test, low-cost highly sensitive molecular tests, assays that can use a variety of reagents, and other products as determined by the Secretary.
The Secretary shall continue such process until the end of the COVID–19 pandemic. For each COVID–19 diagnostic test and associated drug or device that the Secretary intends to market, or contract with another entity for the marketing of, the Secretary shall— submit an application under subsection
(b)or
(j)of section 505 or section 515 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 , 360e) or subsection
(a)or
(j)of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), submit a notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(k) ), or submit a request for classification under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c(f)(2) ) (or enter into a contract with another entity to submit such an application, notification, or request); request an emergency use authorization of the product under section 564 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–3 ) (or enter into a contract with another entity to submit an application for such use); or obtain from the holder of an application approved under subsection
(c)or
(j)of section 505 or section 515 of the Federal Food, Drug, and Cosmetic Act or subsection
(a)or
(k)of section 351 of the Public Health Service Act, or cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act, rights to manufacture such product. With respect to COVID–19 diagnostic tests and associated drugs and devices manufactured pursuant to subsection (a), the Secretary shall— provide such COVID–19 diagnostic tests and associated medical supplies at no cost to Federal, State, local, territorial, and Native health programs, and other domestic health care providers, including domestic commercial health care providers, as determined by the Secretary; and sell additional tests and associated drugs and devices, at-cost, to other commercial entities and international entities not described in paragraph (1). When necessary to fulfill the Secretary’s duties under this section, the Secretary shall acquire the rights to manufacture and market COVID–19 diagnostic tests and associated drugs and devices as authorized under this section. Notwithstanding any other provision of law, the Secretary may issue licenses, as useful for fulfilling the duties under this Act, allowing the Department of Health and Human Services to practice or have practiced (which may include licensure of retroactive practice) any invention in the United States or territories of the United States, including making, using, offering to sell or selling, importing, or exporting such invention, to reference or rely upon clinical trial data submitted to a regulatory authority or the grant of marketing approval, and to access and use otherwise confidential information, including know-how, related to the manufacture of COVID–19 diagnostic tests and associated medical supplies. For any license that involves a non-voluntary authorization to use patented inventions, regulatory test data, data, know-how or other intellectual property rights, the license shall provide for reasonable remuneration to rights holders such as a reasonable royalty on the sales of product, a 1-time payment, or some combination, provided that the combined royalty payments to all rights holders shall not exceed the percentage of sales that is the average percent of all royalty payments reported to the Internal Revenue Service by companies in the pharmaceutical and medicines sector, North American Industry Classification System code 325410, provided that when products are distributed for free, the royalty shall be based upon the cost of goods. When there are multiple rights holders, the allocation of the total royalty payments shall be determined by— agreement among the rights holders; allocation by arbitration among the rights holders; or if neither clause
(i)nor
(ii)applies, by the Secretary. Subject to paragraph (4), the Secretary shall post any contract agreement under subsection
(a)or license issued under paragraph (2)(A) on the public internet website of the Department of Health and Human Services, on the date on which such agreement or license takes effect. In carrying out this section, the Secretary shall enforce applicable law concerning the protection of confidential commercial information and trade secrets. In determining an at-cost price for COVID–19 diagnostic tests and associated medical supplies for purposes of subsection (c)(2), the Secretary shall consider— the cost to the Federal Government of manufacturing the applicable COVID–19 diagnostic test or associated drug or device; and the cost to acquire or manufacture under subparagraph
(A)the applicable COVID–19 diagnostic test or associated drug or device. All prices charged for COVID–19 diagnostic tests and associated medical supplies shall be made publicly available by the Secretary. In awarding contracts under this section, the Secretary shall prioritize entities manufacturing COVID–19 diagnostic tests or associated medical supplies using components originating from, and manufactured in, the United States. All contracts issued under this section shall include a requirement that the contract recipients reasonably price products produced under the contract. The Secretary shall prepare and submit to the President, the Committee on Health, Education, Labor, and Pensions of the Senate, and the Committee on Energy and Commerce of the House of Representatives, a monthly report during the COVID–19 pandemic, and a final report 3 months after such pandemic has concluded, that includes— an assessment of the major supply chain challenges facing health care facilities, medical providers, the Federal Government, State, local, territorial, and Tribal governments, and the private sector in COVID–19 diagnostic tests and associated medical supplies; and a description of the authorization or approval status and available supply of all COVID–19 diagnostic tests and associated medical supplies for which manufacturing has been authorized under this section, including products for which the Secretary has submitted an application for approval, a notification for clearance, or a request for classification to the Food and Drug Administration but has not yet received approval, clearance, or classification, and products for which the Secretary has received approval, clearance, or classification, from the Food and Drug Administration but are not being manufactured. There are authorized to be appropriated to the Secretary for each fiscal year, for purposes of carrying out this section, an amount equal to the proceeds from the sale of COVID–19 diagnostic tests and associated medical supplies described in subsection (c)(2) in the previous fiscal year.
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- 21 USC 360bbb–3
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Sec. 3
Federal manufacturing of COVID–19 diagnostic tests
Cite21 USC 360bbb–3
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