II 117th CONGRESS 1st Session S. 3041 IN THE SENATE OF THE UNITED STATES October 21, 2021 Ms. Duckworth introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act to provide for and support liver illness visibility, education, and research, and for other purposes.

1. Short title This Act may be cited as the Liver Illness Visibility, Education, and Research Act of 2021 . 2. Findings Congress finds the following: (1) Liver cancer is among the fastest-growing cause of cancer death in the United States and among the leading causes of cancer deaths globally. (2) The Division of Cancer Control and Population Sciences of the National Cancer Institute estimated that there will be 42,230 new liver cancer diagnoses in the year 2021, and approximately 30,200 individuals will die from the disease. (3) Liver cancer is a leading cause of cancer death among the Asian American and Pacific Islander community. (4) The most vulnerable Asian Americans are those who are foreign-born, low-income, and living in ethnic enclaves. (5) Asian and Pacific Islander men and women are nearly twice as likely to develop liver cancer compared to the non-Hispanic White population. (6) Among the Asian and Pacific Islander population, the higher incidence rate of liver cancer is partially explained by higher incidence rates of hepatitis B and diabetes comorbidities which are shown to increase an individual’s risk of developing liver cancer. (7) The most common causes of liver cancer include hepatitis B virus and hepatitis C virus infection. (8) Hepatitis B is a primary risk factor for developing liver cancer, and approximately 15 to 25 percent of those chronically infected with hepatitis B develop cirrhosis, liver failure, or liver cancer. (9) More than half of all individuals with hepatitis B in the United States are Asian American or Pacific Islander, though this group accounts for only 6 percent of the population of the United States. (10) Among African immigrants in the United States, the prevalence of hepatitis B infection is approximately 1 in 12, and African immigrants make up 12 percent of those with chronic hepatitis B infection in the United States. (11) Among Hispanic/Latino communities, liver cancer incidence and death rates are twice as high compared to the non-Hispanic White population. (12) Hispanics/Latinos are 70 percent more likely to die from viral hepatitis than non-Hispanic Whites. 3. Liver cancer and disease research Subpart 1 of part C of title IV of the Public Health Service Act ( 42 U.S.C. 285 et seq. ) is amended by adding at the end the following new section: 417H. Liver cancer and disease research (a) Expansion and coordination of activities The Director of the Institute shall expand, intensify, and coordinate the activities of the Institute with respect to research on liver cancer and other liver diseases. (b) Programs for liver cancer In carrying out subsection (a), the Director of the Institute shall provide for an expansion and intensification of the conduct and support of— (1) basic research concerning the etiology and causes of liver cancer; (2) clinical research and related activities concerning the causes, prevention, detection, and treatment of liver cancer; (3) control programs with respect to liver cancer, in accordance with section 412, including community-based programs designed to assist members of medically underserved populations (including women), low-income populations, or minority groups; and (4) information and education programs with respect to liver cancer, in accordance with section 413. (c) Inter-Institute working group The Director of the Institute shall establish an inter-institute working group to coordinate research agendas focused on finding treatments and cures for liver cancer and other liver diseases, including hepatitis B and nonalcoholic steatohepatitis. (d) Grants and cooperative agreements (1) In general The Secretary may award grants and enter into cooperative agreements with entities for the purpose of expanding, conducting, and supporting research on— (A) conditions known to increase an individual’s risk of developing a major liver disease, such as liver cancer, hepatitis B, hepatitis C, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, and cirrhosis of the liver; and (B) early detection and diagnostic measures for such a disease, including the study of molecular pathology and biomarkers for early detection. (2) Experimental treatment and prevention In the case of an entity that is a hospital or a health care facility, the Secretary may award a grant or enter into a cooperative agreement with such an entity for the purpose of supporting an experimental treatment or prevention program for liver cancer carried out by such entity. (3) Authorization of appropriations For purposes of carrying out this subsection, there is authorized to be appropriated $45,000,000 for each of fiscal years 2023 through 2027. . 4. Liver cancer and disease prevention, awareness, and patient tracking grants Subpart I of part D of title III of the Public Health Service Act ( 42 U.S.C. 254b et seq. ) is amended by adding at the end the following new section: 330O. Liver cancer and disease prevention, awareness, and patient tracking grants (a) Prevention initiative grant program (1) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants and enter into cooperative agreements with entities for the purpose of expanding and supporting— (A) prevention activities (including providing screenings, vaccinations, or other preventative interventions) for conditions known to increase an individual’s risk of developing a major liver disease, such as liver cancer, hepatitis B, hepatitis C, nonalcoholic fatty liver disease, nonalcoholic steatohepatitis, and cirrhosis of the liver; (B) activities relating to detection and provision of guidance for individuals at high risk for contracting liver cancer and other liver diseases; and (C) viral hepatitis surveillance to provide for timely and accurate information regarding progress to eliminate viral hepatitis. (2) Report An entity that receives a grant or cooperative agreement under paragraph (1) shall submit to the Secretary, at a time specified by the Secretary, a report describing each activity carried out pursuant to such paragraph and evaluating the effectiveness of such activity in promoting prevention and treatment of liver cancer and other liver diseases. (3) Authorization of appropriations For purposes of carrying out this subsection, there is authorized to be appropriated $90,000,000 for each of fiscal years 2023 through 2027. (b) Awareness initiative grant program (1) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may award grants to eligible entities for the purpose of raising awareness for liver cancer and other liver diseases, which may include the production, dissemination, and distribution of informational materials targeted towards communities and populations with a higher risk for developing liver cancer and other liver diseases. (2) Eligible entities To be eligible to receive a grant under paragraph (1), an entity shall submit to the Secretary an application, at such time, in such manner, and containing such information as the Secretary may require, including a description of how the entity, in disseminating information on liver cancer and other liver diseases pursuant to paragraph (1), will— (A) with respect to any community or population, consult with members of such community or population and provide such information in a manner that is culturally and linguistically appropriate for such community or population; (B) highlight the range of preventative measures and treatments available for liver cancer and other liver diseases; (C) integrate information on available hepatitis B and hepatitis C testing programs into any liver cancer presentations carried out by the entity; and (D) address communities and populations with a higher risk for contracting liver cancer and other liver diseases. (3) Preference In awarding grants under paragraph (1), the Secretary shall give preference to entities that— (A) work with a federally-qualified health center; (B) are community-based organizations; or (C) serve communities and populations with a higher risk for contracting liver cancer and other liver diseases. (4) Report An entity that receives a grant under paragraph (1) shall submit to the Secretary, at a time specified by the Secretary, a report describing each activity carried out pursuant to such paragraph and evaluating the effectiveness of such activity in raising awareness for liver cancer and other liver diseases. (5) Authorization of appropriations For purposes of carrying out this subsection, there is authorized to be appropriated $10,000,000 for each of fiscal years 2022 through 2027. . 5. Hepatitis B research The Director of the National Institutes of Health shall, in collaboration with the Director of the National Institute of Allergy and Infectious Diseases, issue targeted calls for hepatitis B research proposals focused on key research questions identified by the research community and discussed in peer-reviewed research journal articles. 6. Changes relating to National Institute of Diabetes and Digestive and Kidney Diseases (a) Change of name of National Institute of Diabetes and Digestive and Kidney Diseases (1) In general Subpart 3 of part C of title IV of the Public Health Service Act ( 42 U.S.C. 285c et seq. ) is amended in the subpart heading by striking National Institute of Diabetes and Digestive and Kidney Diseases and inserting National Institute of Diabetes and Digestive, Kidney, and Liver Diseases . (2) Treatment of Director of National Institute of Diabetes and Digestive and Kidney Diseases The individual serving as the Director of the National Institute of Diabetes and Digestive and Kidney Diseases as of the date of enactment of this Act may continue to serve as the Director of the National Institute of Diabetes and Digestive, Kidney, and Liver Diseases commencing as of that date. (3) References Any reference to the National Institute of Diabetes and Digestive and Kidney Diseases, or the Director of the National Institute of Diabetes and Digestive and Kidney Diseases, in any law, regulation, document, record, or other paper of the United States shall be deemed to be a reference to the National Institute of Diabetes and Digestive, Kidney, and Liver Diseases, or the Director of the National Institute of Diabetes and Digestive, Kidney, and Liver Diseases, respectively. (4) Conforming amendments (A) Section 401(b)(3) of the Public Health Service Act ( 42 U.S.C. 281(b)(3) ) is amended by striking The National Institute of Diabetes and Digestive and Kidney Diseases. and inserting The National Institute of Diabetes and Digestive, Kidney, and Liver Diseases. . (B) Section 409A(a) of the Public Health Service Act ( 42 U.S.C. 284e(a) ) is amended by striking the National Institute of Diabetes and Digestive and Kidney Diseases and inserting the National Institute of Diabetes and Digestive, Kidney, and Liver Diseases . (b) Purpose of the Institute Section 426 of the Public Health Service Act ( 42 U.S.C. 285c ) is amended— (1) by striking National Institute of Diabetes and Digestive and Kidney Diseases and inserting National Institute of Diabetes and Digestive, Kidney, and Liver Diseases ; and (2) by striking and kidney, urologic, and hematologic diseases and inserting kidney, urologic, and hematologic diseases, and liver diseases . (c) Data systems and information clearinghouses Section 427 of the Public Health Service Act ( 42 U.S.C. 285c–1 ) is amended by adding at the end the following new subsection: (d) The Director of the Institute shall (1) establish the National Liver Diseases Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with liver diseases, including, where possible, data involving general populations for the purpose of detection of individuals with a risk of developing liver diseases, and (2) establish the National Liver Diseases Information Clearinghouse to facilitate and enhance knowledge and understanding of liver diseases on the part of health professionals, patients, and the public through the effective dissemination of information. . (d) Reestablishment of Liver Disease Research Branch within Division of Digestive Diseases and Nutrition as Division of Liver Diseases (1) In general The Liver Disease Research Branch within the Division of Digestive Diseases and Nutrition of the National Institute of Diabetes and Digestive and Kidney Diseases (referred to in this subsection as the Liver Disease Research Branch ) is hereby redesignated and promoted as the Division of Liver Diseases, which shall be within the National Institute of Diabetes and Digestive, Kidney, and Liver Diseases, as redesignated by subsection (a), as a separate division from the other divisions within such Institute. (2) Division Director Section 428 of the Public Health Service Act ( 42 U.S.C. 285c–2 ) is amended— (A) in the section heading, by striking Division directors for diabetes, endocrinology, and metabolic diseases, digestive diseases and nutrition, and kidney, urologic, and hematologic diseases and inserting Division directors for diabetes, endocrinology, and metabolic diseases, digestive diseases and nutrition, kidney, urologic, and hematologic diseases, and liver diseases ; (B) in subsection (a)(1)— (i) in the matter preceding subparagraph (A), by striking and a Division Director for Kidney, Urologic, and Hematologic Diseases and inserting a Division Director for Kidney, Urologic, and Hematologic Diseases, and a Division Director for Liver Diseases ; and (ii) in subparagraph (A), by striking and kidney, urologic, and hematologic diseases and inserting kidney, urologic, and hematologic diseases, and liver diseases ; and (C) in subsection (b)— (i) in the matter preceding paragraph (1), by striking and the Division Director for Kidney, Urologic, and Hematologic Diseases and inserting the Division Director for Kidney, Urologic, and Hematologic Diseases, and the Division Director for Liver Diseases ; and (ii) in paragraph (1), by striking and kidney, urologic, and hematologic diseases and inserting kidney, urologic, and hematologic diseases, and liver diseases . (3) Treatment of Director of Liver Disease Research Branch The individual serving as the Director of the Liver Disease Research Branch as of the date of enactment of this Act may continue to serve as the Division Director for Liver Diseases commencing as of that date. (4) Transfer of authorities The Secretary of Health and Human Services shall delegate to the Division Director for Liver Diseases all duties and authorities that were vested in the Director of the Liver Disease Research Branch as of the day before the date of enactment of this Act. (5) References Any reference to the Liver Disease Research Branch, or the Director of the Liver Disease Research Branch, in any law, regulation, document, record, or other paper of the United States shall be deemed to be a reference to the Division of Liver Diseases, or the Division Director for Liver Diseases, respectively. (e) Interagency coordinating committees Section 429(a) of the Public Health Service Act ( 42 U.S.C. 285c–3(a) ) is amended— (1) in paragraph (1), by striking and kidney, urologic, and hematologic diseases and inserting kidney, urologic, and hematologic diseases, and liver diseases ; and (2) in the matter following paragraph (2), by striking and a Kidney, Urologic, and Hematologic Diseases Coordinating Committee and inserting a Kidney, Urologic, and Hematologic Diseases Coordinating Committee, and a Liver Diseases Coordinating Committee . (f) Advisory boards Section 430 of the Public Health Service Act ( 42 U.S.C. 285c–4 ) is amended— (1) in subsection (a), by striking and the National Kidney and Urologic Diseases Advisory Board and inserting the National Kidney and Urologic Diseases Advisory Board, and the Liver Diseases Advisory Board ; and (2) in subsection (b)(2)(A)(i)— (A) by striking the Director of the National Institute of Diabetes and Digestive and Kidney Diseases and inserting the Director of the National Institute of Diabetes and Digestive, Kidney, and Liver Diseases ; and (B) by striking and the Division Director of the National Institute of Diabetes and Digestive and Kidney Diseases and inserting and the Division Director of the National Institute of Diabetes and Digestive, Kidney, and Liver Diseases . (g) Research and training centers Section 431 of the Public Health Service Act ( 42 U.S.C. 285c–5 ) is amended— (1) by redesignating subsection (e) as subsection (f); and (2) by inserting after subsection (d) the following new subsection: (e) The Director of the Institute shall provide for the development or substantial expansion of centers for research in liver diseases. Each center developed or expanded under this subsection— (1) shall utilize the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such research qualifications as may be prescribed by the Secretary; (2) shall develop and conduct basic and clinical research into the cause, diagnosis, early detection, prevention, control, and treatment of liver diseases and related functional, congenital, metabolic, or other complications resulting from such diseases; (3) shall encourage research into and programs for— (A) providing information for patients with such diseases and complications and the families of such patients, physicians and others who care for such patients, and the general public; (B) model programs for cost effective and preventive patient care; and (C) training physicians and scientists in research on such diseases and complications; and (4) may perform research and participate in epidemiological studies and data collection relevant to liver diseases in order to disseminate such research, studies, and data to the health care profession and to the public. . (h) Advisory council subcommittees Section 432 of the Public Health Service Act ( 42 U.S.C. 285c–6 ) is amended— (1) by striking and a subcommittee on kidney, urologic, and hematologic diseases and inserting a subcommittee on kidney, urologic, and hematologic diseases, and a subcommittee on liver diseases ; and (2) by striking and kidney, urologic, and hematologic diseases and inserting kidney, urologic, and hematologic diseases, and liver diseases .