HB964 - Relating to the regulation of laboratory developed tests during a federally declared public health emergency.

      By: Harrison H.B. No. 964       A BILL TO BE ENTITLED   AN ACT   relating to the regulation of laboratory developed tests during a   federally declared public health emergency.          BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:          SECTION 1.  Subtitle D, Title 2, Health and Safety Code, is   amended by adding Chapter 100B to read as follows:   CHAPTER 100B. REGULATION OF LABORATORY DEVELOPED TESTS DURING   FEDERALLY DECLARED PUBLIC HEALTH EMERGENCY           Sec. 100B.001.  DEFINITIONS. In this chapter:                 (1)     "Federally declared public health emergency"   means:                       (A)     a public health emergency declared by the   United States secretary of health and human services under 42   U.S.C. Section 247d; or                       (B)     an emergency or disaster declared, including   under a renewal of the declaration, by the president of the United   States in relation to a public health emergency described by   Paragraph (A) under:                             (i)     the National Emergencies Act (50 U.S.C.   Section 1601 et seq.); or                             (ii)     the Robert T. Stafford Disaster Relief   and Emergency Assistance Act (42 U.S.C. Section 5121 et seq.).                 (2)     "Laboratory developed test" means a test used in   the same clinical laboratory in Texas that designed and   manufactured the test to detect a pathogen or agent or to diagnose   a health condition caused by a pathogen or agent, and as result,   such test is deemed to be a test used and manufactured solely   intrastate.           Sec.   100B.002.     PROHIBITED REGULATION BY UNITED STATES FOOD   AND DRUG ADMINISTRATION.   (a)     Notwithstanding any other law,   during a federally declared public health emergency, a clinical   laboratory is considered a state agency for purposes of regulation   by the United States Food and Drug Administration when the   laboratory is performing a laboratory developed test on a pathogen   or agent that is the basis for the emergency declaration or to   diagnose the health condition that is the basis for the emergency     declaration.           (b)     Subsection (a) does not affect a clinical laboratory's   liability under any applicable state or federal law, except to the   extent the laboratory's liability is limited under the Public   Readiness and Emergency Preparedness Act (42 U.S.C. Section 247d)   and further does not authorize any state agency to exercise any   authority over laboratories that it did not possess prior the   issuance of the public health emergency.          SECTION 2.  This Act takes effect immediately if it receives   a vote of two-thirds of all the members elected to each house, as   provided by Section 39, Article III, Texas Constitution. If this   Act does not receive the vote necessary for immediate effect, this   Act takes effect September 1, 2025.