Sec. 3. Continuing support for research on endemic orphan fungal diseases
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Subtitle F of title II of the 21st Century Cures Act ( Public Law 114–255 ) is amended by inserting after section 2062 ( 42 U.S.C. 284s ) the following new section: The Secretary of Health and Human Services (in this section referred to as the Secretary ) shall continue to conduct or support epidemiological, basic, translational, and clinical research related to endemic orphan fungal diseases, including coccidioidomycosis (commonly known as and referred to in this section as Valley Fever ).
The Secretary shall ensure that each triennial report under section 403 of the Public Health Service Act ( 42 U.S.C. 283 ) includes information on actions undertaken by the National Institutes of Health to carry out subsection
(a)with respect to endemic orphan fungal diseases, including Valley Fever. The Secretary shall establish a working group, to be known as the Valley Fever Working Group (referred to in this section as the Working Group ), comprised of representatives of appropriate Federal agencies and other non-Federal entities, to provide expertise and to review all efforts within the Department of Health and Human Services related to Valley Fever, to help ensure interagency coordination and minimize overlap, and to examine research priorities. The Working Group shall— not later than 2 years after the date of enactment of this Act, develop or update a summary of— ongoing Valley Fever research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with Valley Fever; advances made pursuant to such research; Federal activities related to Valley Fever, including— epidemiological activities related to Valley Fever; and basic, clinical, and translational Valley Fever research related to the pathogenesis, prevention, diagnosis, and treatment of Valley Fever; gaps in Valley Fever research described in clause (iii)(II); the Working Group’s meetings required under paragraph (4); and the comments received by the Working Group; make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and solicit input from States, localities, and nongovernmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, and surveillance activities. The members of the Working Group shall represent a diversity of scientific disciplines and views and shall be composed of the following members: Seven Federal members, consisting of one or more representatives of each of the following: The Office of the Assistant Secretary for Health. The Food and Drug Administration. The Centers for Disease Control and Prevention. The National Institutes of Health. Such other agencies and offices of the Department of Health and Human Services as the Secretary determines appropriate. Seven non-Federal public members, consisting of representatives of the following categories: Physicians and other medical providers with experience in diagnosing and treating Valley Fever. Scientists or researchers with expertise. Patients and their family members. Nonprofit organizations that advocate for patients with respect to Valley Fever. Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group. The Working Group shall meet annually. Not later than 2 years after the date of enactment of this Act, and every 2 years thereafter until termination of the Working Group pursuant to paragraph (7), the Working Group shall— submit a report on its activities under paragraph (2)(A) and any recommendations under paragraph (2)(B) to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate; and make such report publicly available on the internet website of the Department of Health and Human Services. The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act (5 U.S.C. App.). The Working Group under this section shall terminate 5 years after the date of enactment of this Act. The term endemic orphan fungal disease has the meaning given such term in section 529B(a) of the Federal Food, Drug, and Cosmetic Act. . Section 1(b) of the 21st Century Cures Act ( Public Law 114–255 ) is amended in the table of contents, by inserting after the item relating to section 2062 the following: Sec. 2062A. Endemic orphan fungal diseases. .
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Sec. 3
Continuing support for research on endemic orphan fungal diseases
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