I 118th CONGRESS 2d Session H. R. 9098 IN THE HOUSE OF REPRESENTATIVES July 23, 2024 Ms. Clarke of New York introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To provide for surveillance of Clostridioides difficile , and for other purposes.

1. Short title; findings and purposes (a) Short title This Act may be cited as the Peggy Lillis Clostridioides difficile Inclusion Act . (b) Findings Congress finds the following: (1) Clostridioides difficile (referred to in this section as C.diff ) is a bacterium that can cause a range of symptoms from diarrhea to life-threatening inflammation of the colon. (2) C. diff infections are a significant public health concern, leading to substantial morbidity, mortality, and healthcare costs in the United States. An estimated 500,000 infections, including 20,000 in children, occur in the United States each year, causing an estimated 30,000 deaths. Because C.diff infections is not mandatorily reported by outpatient facilities, skilled nursing facilities, and others, this number likely does not account for the full burden of C. diff infections. The estimated attributable cost of C.diff infections in the United States is $1,000,000,000. (3) Tracking and monitoring of C. diff cases is essential for understanding the disease epidemiology, implementing effective prevention and control strategies, and ensuring public health and health care providers have to necessary resources to improve health outcomes, address health disparities, and reduce mortality. While C. diff is more commonly found in White patients, Black patients tend to have worse outcomes—including greater risk for severe C.diff infections and greater risk for mortality. (c) Purposes The purpose of this Act is to require the Centers for Disease Control and Prevention to include C.diff as a Nationally Notifiable Infectious Disease and Condition. 2. Improving surveillance of Clostridium difficile (a) Inclusion as nationally notifiable disease or condition Not later than 180 days after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (in this section referred to as the Secretary ) shall add Clostridioides difficile (referred to in this section as C.diff ) to the list of nationally notifiable diseases or conditions published by the Council of State and Territorial Epidemiologists and the Centers for Disease Control and Prevention. (b) Reporting requirements (1) States The Secretary shall, pursuant to section 301 of the Public Health Service Act ( 42 U.S.C. 241 ), issue regulations requiring each State to collect and report data on confirmed cases of C.diff to the Secretary. (2) Reporting entities Any entity required to submit information to the Secretary, pursuant to such section 301, with respect to cases of a nationally notifiable disease or condition, including a health care facility or laboratory, shall submit such information to the Secretary with respect to cases of C.diff . (3) Data elements The Secretary shall establish standardized data elements, including demographic information, clinical information, and laboratory results, for the reporting of cases of C.diff under this subsection. (c) Severability If any provision of this Act, or the application thereof to any person or circumstances, is held invalid, the remainder of the Act and the application of the provisions to other persons or circumstances shall not be affected. (d) State defined In this section, the term State means each of the several States, the District of Columbia, each territory or possession of the United States, and each federally recognized Indian Tribe.