Bill Text: TX HB964 | 2025-2026 | 89th Legislature | Introduced
Bill Title: Relating to the regulation of laboratory developed tests during a federally declared public health emergency.
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced) 2024-11-12 - Filed [HB964 Detail]
Download: Texas-2025-HB964-Introduced.html
| By: Harrison | H.B. No. 964 | |
|
|
||
|
|
||
| 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. | ||
