To direct the Secretary of Health and Human Services to conduct a study on the feasibility of developing an accurate and reliable standardized test for detecting tuberculosis in tissue from a human cadaver, and for other purposes.

To direct the Secretary of Health and Human Services to conduct a study on the feasibility of developing an accurate and reliable standardized test for detecting tuberculosis in tissue from a human cadaver, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. Short title.

SEC. 2. NIH study on development of standardized tuberculosis test for human cadaver tissue.

(a) Study.—Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the “Secretary”) shall conduct a comprehensive study on the feasibility of developing an accurate and reliable standardized test, or testing strategy, for detecting tuberculosis in tissue from a human cadaver (in this section referred to as a “TB test”) for the purpose of improving donor screening, transplant safety, and the integrity of organ and tissue donation systems.

(b) Consultation.—The Secretary shall conduct the study under subsection (a) in consultation with—

(1) the Director of the National Institutes of Health;

(2) the Director of the Centers for Disease Control and Prevention;

(3) the Commissioner of Food and Drugs;

(4) the Administrator of the Health Resources and Services Administration; and

(5) relevant stakeholders that have experience with tissue or organ donations and post-mortem systems, including organ procurement organizations and tissue banks.

(c) Elements.—In conducting the study under subsection (a), the Secretary may include, as appropriate—

(1) assess the current state of scientific knowledge and any research gap related to TB tests;

(2) evaluate methodologies for testing tissue from a human cadaver;

(3) consider any issue related to implementing such a methodology with respect to a TB test, including specimen collection, timing requirements for testing, quality assurance, and biosafety;

(4) assess the feasibility of conducting pilot and implementation studies on TB tests using tissue collected from—

(A) individuals across diverse populations, including high-risk and underserved communities; and

(B) multiple clinical and tissue recovery sites, including hospitals, organ procurement organizations, tissue banks, and offices of medical examiners;

(5) develop recommendations for interagency coordination, as appropriate, to support the validation, review, and implementation of a TB test; and

(6) identify any additional scientific, operational, or regulatory barrier to the development and implementation of a TB test.

(d) Report.—Not later than 3 years after the date of enactment of this Act, the Secretary shall submit to Congress a report describing—

(1) the findings and conclusions of the Secretary based on the study; and

(2) a recommendation for developing and implementing a TB test, including any congressional or regulatory action necessary to address any barrier to such development or implementation.

(e) Funding.—For each of fiscal years 2027 through 2031, the Secretary may use amounts appropriated to support the Department of Health and Human Services to carry out this section, subject to the availability of appropriations.