cheaptrix/billsum-US_congress_and_house huggingface dataset:
Student Loan Tax Debt Relief Act

To amend the Internal Revenue Code of 1986 to exclude from gross income any discharge of income contingent and income-based student loan indebtedness. 1. Short title This Act may be cited as the Student Loan Tax Debt Relief Act 2. Exclusion from gross income for discharge of income contingent and income-based student loan indebtedness (a) In general Paragraph (1) of section 108(f) (1) In general In the case of an individual, gross income does not include any amount which (but for this subsection) would be includible in gross income by reason of the discharge (in whole or in part) of any student loan if such discharge was pursuant to— (A) a provision of such loan under which all or part of the indebtedness of the individual would be discharged if the individual worked for a certain period of time in certain professions for any of a broad class of employers, or (B) subsections (d)(1)(D) and (e)(7) of section 455 or section 493C(b)(7) of the Higher Education Act of 1965 (relating to income contingent and income-based repayment, respectively). . (b) Effective date The amendments made by this section shall apply to discharges of indebtedness after the date of the enactment of this Act.

Summary: Student Loan Tax Debt Relief Act Amends the Internal Revenue Code to expand the exclusion from gross income of income attributable to the discharge of student loan indebtedness to include indebtedness discharged pursuant to income-contingent and income-based repayment plans.
Safe and Secure Drinking Water Act of 2015

To direct the Administrator of the Environmental Protection Agency to publish a health advisory and submit reports with respect to Microcystins in drinking water. 1. Short title This Act may be cited as the Safe and Secure Drinking Water Act of 2015 2. Microcystins in drinking water (a) Health advisory Not later than 90 days after the date of enactment of this Act, the Administrator of the Environmental Protection Agency (in this Act referred to as the Administrator (1) (A) the level of Microcystins in drinking water below which the water is expected to be safe for human consumption; and (B) feasible treatment techniques and other means for achieving such level; and (2) standardized procedures for testing for Microcystins in drinking water. (b) Periodic reports (1) In general Until the Administrator makes a determination of whether or not to regulate Microcystins in drinking water under section 1412(b) of the Safe Drinking Water Act ( 42 U.S.C. 300g–1(b) (2) Reporting requirements Not later than 120 days after the date of enactment of this Act, and every year thereafter, the Administrator shall submit to the Congress a report on the following: (A) The status of the Administrator’s efforts to determine whether to regulate drinking water with respect to the level of Microcystins. (B) The steps taken by the Administrator to promote testing of drinking water for Microcystins in areas that have been affected by harmful algal blooms. (C) An analysis of available treatment techniques and other means for addressing Microcystins in drinking water.

Summary: Safe and Secure Drinking Water Act of 2015 This bill requires the Environmental Protection Agency (EPA) to develop and publish within 90 days a health advisory including recommendations on: (1) the level of microcystins (toxins produced by freshwater cyanobacteria, also known as blue-green algae) in drinking water that is safe for human consumption; (2) feasible treatment techniques and other means for achieving a safe level; and (3) standardized procedures for testing for microcystins in drinking water. Until the EPA makes a determination on whether to regulate microcystins in drinking water, it must report on: (1) the status of the determination, (2) the steps taken by the EPA to promote testing of drinking water for microcystins in areas that have been affected by harmful algal blooms, and (3) an analysis of available treatment techniques and other means for addressing microcystins in drinking water. The EPA must submit the report within 120 days and every year thereafter.
To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review.

To amend the Federal Food, Drug, and Cosmetic Act with respect to enhancing combination products review. 1. Enhancing combination products review Section 503(g)(4)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353(g)(4)(C) (iii) Not later than 18 months after the date of the enactment of the 21st Century Cures Act .

Summary: This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration to describe the responsibilities of each agency center charged with reviewing drugs, medical devices, or biological products when reviewing a product that is a combination of drug, medical device, or biological product.
Adoption Tax Credit Refundability Act of 2015

To amend the Internal Revenue Code of 1986 to provide for a refundable adoption tax credit. 1. Short title This Act may be cited as the Adoption Tax Credit Refundability Act of 2015 2. Refundable adoption tax credit (a) Credit made refundable The Internal Revenue Code of 1986 is amended— (1) by redesignating section 23 as section 36C, and (2) by moving section 36C (as so redesignated) from subpart A of part IV of subchapter A of chapter 1 to the location immediately before section 37 in subpart C of part IV of subchapter A of chapter 1. (b) Conforming Amendments (1) Section 25(e)(1)(C) of such Code is amended by striking sections 23, 25D, and 1400C sections 25D and 1400C (2) Section 36C of such Code, as so redesignated, is amended— (A) in subsection (b)(2)(A), by striking (determined without regard to subsection (c)) (B) by striking subsection (c), and (C) by redesignating subsections (d) through (i) as subsections (c) through (h), respectively. (3) Section 137 of such Code is amended— (A) in subsection (d), by striking section 23(d) section 36C(c) (B) in subsection (e), by striking subsections (e), (f), and (g) of section 23 subsections (d), (e), and (f) of section 36C (4) Section 1016(a)(26) is amended by striking 23(g) 36C(f) (5) Section 6211(b)(4)(A) of such Code is amended by inserting 36C, 168(k)(4) (6) The table of sections for subpart A of part IV of subchapter A of chapter 1 of such Code of 1986 is amended by striking the item relating to section 23. (7) Paragraph (2) of section 1324(b) of title 31, United States Code, as amended by this Act, is amended by inserting 36C, 36B, (8) The table of sections for subpart C of part IV of subchapter A of chapter 1 Sec. 36C. Adoption expenses. (c) Effective date The amendments made by this section shall apply to taxable years beginning after December 31, 2014.

Summary: Adoption Tax Credit Refundability Act of 2015 Amends the Internal Revenue Code to make the tax credit for adoption expenses refundable.
To amend the Public Health Service Act with respect to appropriate age groupings to be included in research studies involving human subjects.

To amend the Public Health Service Act with respect to appropriate age groupings to be included in research studies involving human subjects. 1. Appropriate age groupings in clinical research (a) Input from experts Not later than 180 days after the date of enactment of this Act, the Director of the National Institutes of Health shall convene a workshop of experts on pediatrics and experts on geriatrics to provide input on— (1) appropriate age groupings to be included in research studies involving human subjects; and (2) acceptable scientific justifications for excluding participants from a range of age groups from human subjects research studies. (b) Guidelines Not later than 180 days after the conclusion of the workshop under subsection (a), the Director of the National Institutes of Health shall publish guidelines— (1) addressing the consideration of age as an inclusion variable in research involving human subjects; and (2) identifying criteria for justifications for any age-related exclusions in such research. (c) Public availability of findings and conclusions The Director of the National Institutes of Health shall— (1) make the findings and conclusion resulting from the workshop under subsection (a) available to the public on the website of the National Institutes of Health; and (2) not less than biennially, disclose to the public on such website the number of children included in research that is conducted or supported by the National Institutes of Health, disaggregated by developmentally appropriate age group, race, and gender.

Summary: This bill requires the National Institutes of Health (NIH) to convene a workshop within 180 days of enactment of this Act on appropriate age groupings and age exclusions in human research. Not later than 180 days after the conclusion of the workshop, the NIH must publish guidelines addressing consideration of age in human research. The NIH must publish the number of children included in NIH research disaggregated by age group, race, and gender.
To amend part B of title XVIII of the Social Security Act regarding high cost durable medical equipment, and for other purposes.

To amend part B of title XVIII of the Social Security Act regarding high cost durable medical equipment, and for other purposes. __. Prior authorization process for certain high cost durable medical equipment, prosthetics, orthotics, and supplies under the Medicare program Section 1834(a)(15) of the Social Security Act ( 42 U.S.C. 1395m(a)(15) (1) in the paragraph heading, by striking items items; prior authorization process for certain high cost durable medical equipment, prosthetics, orthotics, and supplies (2) by adding at the end the following new subparagraph: (D) Prior authorization process for certain high cost durable medical equipment, prosthetics, orthotics, and supplies (i) In general Not later than 1 year after the date of the enactment of this subparagraph, the Secretary shall begin the process to develop and implement a prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies. A claim for an item of durable medical equipment, a prosthetic, an orthotic, or a supply that has received prior approval through the prior authorization process shall be exempt from subsequent pre- and post-payment audits and only subject to audits for systematic fraud and abuse. (ii) Consideration of factors The Secretary shall consider the following factors in developing and implementing the prior authorization process under this subparagraph: (I) Beneficiary access to timely care. (II) Alignment with the best practices of commercial managed care plans and Medicare Advantage plans under part C that have expertise in prior authorization processes. (III) Implementation of standard medical necessity evaluation prior authorization requests for physician and hospital referral agents and non-physician practitioners. (IV) Accounting for same day delivery expectations by providing for expedited emergency review for certain items, including oxygen. (iii) Implementation The Secretary shall promulgate a regulation to carry out the prior authorization process under this subparagraph. The regulation shall— (I) ensure that stakeholders participate in the development of the process; and (II) place priority on prior authorization of items that are subject to a high number of contractor audits, including oxygen. .

Summary: Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services to begin the process to develop and implement a prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies.
To amend the Federal Food, Drug, and Cosmetic Act with respect to broader application of Bayesian statistics and adaptive trial designs.

To amend the Federal Food, Drug, and Cosmetic Act with respect to broader application of Bayesian statistics and adaptive trial designs. 1. Broader application of Bayesian statistics and adaptive trial designs (a) Proposals for use of innovative statistical methods in clinical protocols for drugs and biological products For purposes of assisting sponsors in incorporating adaptive trial design and Bayesian methods into proposed clinical protocols and applications for new drugs under section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 42 U.S.C. 262 (b) Guidance addressing use of adaptive trial designs and Bayesian methods (1) In general The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs (in this subsection referred to as the Secretary (A) update and finalize the draft guidance addressing the use of adaptive trial design for drugs and biological products; and (B) issue draft guidance on the use of Bayesian methods in the development and regulatory review and approval or licensure of drugs and biological products. (2) Contents The guidances under paragraph (1) shall address— (A) the use of adaptive trial designs and Bayesian methods in clinical trials, including clinical trials proposed or submitted to help satisfy the substantial evidence standard under section 505(d) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(d) (B) how sponsors may obtain feedback from the Secretary on technical issues related to modeling and simulations prior to— (i) completion of such modeling or simulations; or (ii) the submission of resulting information to the Secretary; (C) the types of quantitative and qualitative information that should be submitted for review; and (D) recommended analysis methodologies. (3) Public meeting Prior to updating or developing the guidances required by paragraph (1), the Secretary shall consult with stakeholders, including representatives of regulated industry, academia, patient advocacy organizations, and disease research foundations, through a public meeting to be held not later than 1 year after the date of enactment of this Act. (4) Schedule The Secretary shall publish— (A) the final guidance required by paragraph (1)(A) not later than 18 months after the date of the public meeting required by paragraph (3); and (B) the guidance required by paragraph (1)(B) not later than 48 months after the date of the public meeting required by paragraph (3).

Summary: This bill requires the Food and Drug Administration to issue guidance that addresses using alternative statistical methods, including adaptive trial design and Bayesian methods, in clinical trials and in the development and review of drugs and biological products.
To amend the Public Health Service Act with respect to the Silvio O. Conte Senior Biomedical Research Service.

To amend the Public Health Service Act with respect to the Silvio O. Conte Senior Biomedical Research Service. 1. Silvio O. Conte Senior Biomedical Research Service (a) Hiring and retention authority Section 228 of the Public Health Service Act ( 42 U.S.C. 237 (1) in the section heading, by inserting and Biomedical Product Assessment Research (2) in subsection (a)(1), by striking Silvio O. Conte Senior Biomedical Research Service, not to exceed 500 members Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service (in this section referred to as the Service (3) by amending subsection (a)(2) to read as follows: (2) The authority established in paragraph (1) may not be construed to require the Secretary to reduce the number of employees serving under any other employment system in order to offset the number of members serving in the Service. ; (4) in subsection (b)— (A) in the matter preceding paragraph (1), by striking or clinical research evaluation , clinical research evaluation or biomedical product assessment evaluation (B) in paragraph (1), by inserting or a master's level degree in engineering, bioinformatics, or a related or emerging field, (5) in subsection (d), by striking and shall not exceed the rate payable for level I of the Executive Schedule unless approved by the President under section 5377(d)(2) of title 5, United States Code and shall not exceed the rate payable for the President (6) by striking subsection (e); and (7) by redesignating subsections (f) and (g) as subsections (e) and (f), respectively. (b) Report Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit, and publish on the website of the Department of Health and Human Services a report on the implementation of the amendments made by subsection (a), including whether the amendments have improved the ability of the Food and Drug Administration to hire and retain qualified experts to fulfill obligations specified under user fee agreements.

Summary: This bill amends the Public Health Service Act to revise the Silvio O. Conte Senior Biomedical Research Service to: (1) remove the limit on the number of members, (2) expand eligibility for appointment, (3) set a maximum pay rate, and (4) remove the option for members to contribute to the retirement system of an institution of higher education. The Department of Health and Human Services must report on the implementation of these amendments, including whether the amendments improved the ability of the Food and Drug Administration to hire and retain qualified experts to fulfill obligations under user fee agreements.
To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.

To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics. 1. CLIA waiver study design guidance for in vitro diagnostics (a) Draft revised guidance Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall publish a draft guidance that— (1) revises section V Demonstrating Insignificant Risk of an Erroneous Result— Accuracy Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices (2) includes guidance on the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy. (b) Final revised guidance The Secretary of Health and Human Services shall finalize the draft guidance published under subsection (a) not later than 12 months after the comment period for such draft guidance closes.

Summary: This bill requires the Department of Health and Human Services to publish guidance that revises “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” and includes guidance on using comparable performance between types of users to demonstrate the accuracy of a medical device.
To authorize the Commissioner of Food and Drugs to award grants for studying the process of continuous drug manufacturing.

To authorize the Commissioner of Food and Drugs to award grants for studying the process of continuous drug manufacturing. 1. Grants for studying the process of continuous drug manufacturing (a) In general The Commissioner of Food and Drugs may award grants to institutions of higher education and nonprofit organizations for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques. (b) Definitions In this section: (1) The term drug 21 U.S.C. 321 (2) The term biological product 42 U.S.C. 262(i) (3) The term institution of higher education 20 U.S.C. 1001 (c) Authorization of appropriations There is authorized to be appropriated $5,000,000 for each of fiscal years 2016 through 2020 to carry out this section.

Summary: This bill authorizes the Commissioner of Food and Drugs to award grants to institutions of higher education and nonprofit organizations to study and recommend improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.
To express the sense of Congress with respect to enabling Food and Drug Administration scientific engagement.

To express the sense of Congress with respect to enabling Food and Drug Administration scientific engagement. 1. Enabling FDA scientific engagement It is the sense of Congress that participation in or sponsorship of scientific conferences and meetings is essential to the mission of the Food and Drug Administration.

Summary: This bill expresses the sense of Congress that participation in or sponsorship of scientific conferences and meetings is essential to the mission of the Food and Drug Administration.
To amend title XIX of the Social Security Act to require the use of electronic visit verification for personal care services furnished under the Medicaid program, and for other purposes.

To amend title XIX of the Social Security Act to require the use of electronic visit verification for personal care services furnished under the Medicaid program, and for other purposes. 1. Electronic visit verification system required for personal care services under Medicaid (a) In general Section 1903 of the Social Security Act ( 42 U.S.C. 1396b (l) (1) Subject to paragraph (2), with respect to any amount expended for medical assistance for services described in section 1915(d)(5)(C)(i) or such similar services as the Secretary may specify furnished in a calendar quarter beginning on or after January 1, 2018, unless a State has in place an electronic visit verification system for personal care services specified under regulations under section 1905(a)(24) (A) for calendar quarters in 2018 and 2019, by .25 percentage points; (B) for calendar quarters in 2020, by .5 percent percentage points; (C) for calendar quarters in 2021, by .75 percentage points; and (D) for calendar quarters in 2022 and each year thereafter, by 1 percentage point. (2) Paragraph (1) shall not apply in the case of a State that, as of the date of the enactment of this subsection, has in place any system for the electronic verification of visits conducted as part of personal care services specified under regulations under section 1905(a)(24) furnished under the State plan. (3) In this subsection, the term electronic visit verification system (A) the date of the service; (B) the site of the service; (C) the provider of the service; and (D) the duration of the service. . (b) Rule of construction Nothing in the amendment made by this section may be construed as establishing an employer-employee relationship between the agency or entity that provides for personal care services specified under regulations under section 1905(a)(24) of the Social Security Act ( 42 U.S.C. 1396d(a)(24)

Summary: Amends title XIX (Medicaid) of the Social Security Act to require states to have in place a system for the electronic verification of visits conducted as part of personal care services or else have their federal medical assistance percentage reduced by specified amounts.
To amend the Public Health Service Act to authorize a program of high-risk, high-reward research.

To amend the Public Health Service Act to authorize a program of high-risk, high-reward research. 1. High-risk, high-reward research Part B of title IV of the Public Health Service Act ( 42 U.S.C. 284 et seq. 409K. High-risk, high-reward research program The director of each national research institute shall, as appropriate— (1) establish programs to conduct or support research projects that pursue innovative approaches to major contemporary challenges in biomedical research that involve inherent high risk, but have the potential to lead to breakthroughs; and (2) set aside a specific percentage of funding, to be determined by the Director of NIH for each national research institute, for such projects. .

Summary: This bill amends the Public Health Service Act to require each national research institute to conduct or support high-risk, high-reward research that pursues innovative approaches to major biomedical challenges. The National Institutes of Health determines the percentage of funding each national research institute must set aside for this research.