Title: Liver Illness Visibility, Education, and Research Act of 2021
Policy area: Health

Summary:
Liver Illness Visibility, Education, and Research Act of 2021  This bill expands and coordinates activities related to the research of liver cancer and liver disease, including causes, prevention, detection, and treatment.
Specifically, the National Cancer Institute must establish a working group to coordinate efforts across the National Institutes of Health to cure liver cancer and liver disease, including research into such cases resulting from hepatitis B. The institute may also award grants for developing preventative and diagnostic measures and supporting experimental treatment options.  The bill further establishes grant programs, administered by the Centers for Disease Control and Prevention, to support liver disease prevention services, diagnostics, and hepatitis tracking programs and to raise awareness about liver disease within high-risk communities.  The renamed National Institute of Diabetes and Digestive, Kidney, and Liver Diseases also must prioritize programs addressing liver disease, including (1) establishing a national clearinghouse for patient data, and (2) developing or expanding the centers for research of liver disease.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3041 Introduced in Senate (IS)]

<DOC>






117th CONGRESS
  1st Session
                                S. 3041

To amend the Public Health Service Act to provide for and support liver 
  illness visibility, education, and research, and for other purposes.


_______________________________________________________________________


                   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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Liver Illness Visibility, Education, 
and Research Act of 2021''.

SEC. 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.

SEC. 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:

``SEC. 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.''.

SEC. 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:

``SEC. 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.''.

SEC. 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.

SEC. 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''.
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