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A BILL TO BE ENTITLED
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AN ACT
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relating to the regulation of laboratory developed tests during a |
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federally declared public health emergency. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subtitle D, Title 2, Health and Safety Code, is |
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amended by adding Chapter 100B to read as follows: |
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CHAPTER 100B. REGULATION OF LABORATORY DEVELOPED TESTS DURING |
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FEDERALLY DECLARED PUBLIC HEALTH EMERGENCY |
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Sec. 100B.001. DEFINITIONS. In this chapter: |
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(1) "Federally declared public health emergency" |
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means: |
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(A) a public health emergency declared by the |
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United States secretary of health and human services under 42 |
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U.S.C. Section 247d; or |
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(B) an emergency or disaster declared, including |
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under a renewal of the declaration, by the president of the United |
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States in relation to a public health emergency described by |
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Paragraph (A) under: |
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(i) the National Emergencies Act (50 U.S.C. |
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Section 1601 et seq.); or |
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(ii) the Robert T. Stafford Disaster Relief |
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and Emergency Assistant Act (42 U.S.C. Section 5121 et seq.). |
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(2) "Laboratory developed test" means a test used in |
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the same clinical laboratory in Texas that designed and |
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manufactured the test to detect a pathogen or agent or to diagnose |
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a health condition caused by a pathogen or agent, and as result, |
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such test is deemed to be a test used and manufactured solely |
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intrastate. |
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Sec. 100B.002. PROHIBITED REGULATION BY UNITED STATES FOOD |
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AND DRUG ADMINISTRATION. (a) Notwithstanding any other law, |
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during a federally declared public health emergency, a clinical |
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laboratory is considered a state agency for purposes of regulation |
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by the United States Food and Drug Administration when the |
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laboratory is performing a laboratory developed test on a pathogen |
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or agent that is the basis for the emergency declaration or to |
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diagnose the health condition that is the basis for the emergency |
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declaration. |
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(b) Subsection (a) does not affect a clinical laboratory's |
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liability under any applicable state or federal law, except to the |
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extent the laboratory's liability is limited under the Public |
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Readiness and Emergency Preparedness Act (42 U.S.C. Section 247d) |
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and further does not authorize any state agency to exercise any |
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authority over laboratories that it did not possess prior the |
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issuance of the public health emergency. |
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SECTION 2. This Act takes effect immediately if it receives |
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a vote of two-thirds of all the members elected to each house, as |
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provided by Section 39, Article III, Texas Constitution. If this |
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Act does not receive the vote necessary for immediate effect, this |
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Act takes effect September 1, 2023. |