Sec. 7. Reports and guidance on COVID–19 diagnostic testing
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Not later than 30 days after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue updated guidance on the development of rapid COVID–19 diagnostic tests, the provision of such tests, including in nonclinical environments, and the appropriate collection and electronic reporting of results (including geographic and demographic data, including with respect to race and ethnicity) and data regarding such tests to Federal, State, local, and Tribal public health officials.
For purposes of paragraph (1), the term rapid COVID–19 diagnostic test means a COVID–19 diagnostic test that can be performed by a user, with or without the need of a medical professional or medical supervisor, and that can produce results within 1 hour of application. Not later than 30 days after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Director of the Centers for Disease Control and Prevention, shall issue guidance on COVID–19 surveillance testing best practices.
Such guidance shall address how COVID–19 surveillance testing can be used to keep qualified entities, as defined in section 5(a), open to the public, and how tests with differing accuracy standards, including rapid point of care antigen tests and pooled molecular tests, can each be used in COVID–19 surveillance testing at qualified entities among children and adult. For purposes of paragraph (1), the term COVID-19 surveillance testing means the ongoing, systematic collection, analysis, and interpretation of COVID–19 diagnostic test results for the purpose of monitoring for a community- or population-level infection and disease, or to characterize the incidence and prevalence of disease.
Not later than 30 days after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs and in consultation with the Director of the Centers for Disease Control and Prevention, shall issue recommendations on the total number of COVID–19 diagnostic tests that should be conducted in the United States per day to control the spread of COVID–19, with a focus on the number of tests necessary to protect essential workers, as defined in section 5(a), from COVID–19 infection. 19 diagnostic test performance Not later than 30 days after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue a report comparing the performance of COVID–19 diagnostic tests on the market, including a comparison of the differing sensitivity and accuracy of such tests in asymptomatic and symptomatic populations and children and adults. 19 diagnostic test approval pathways Not later than 30 days after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall review the process for approving COVID–19 diagnostic tests for market, 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, and take steps as necessary to expedite such process, as appropriate.