hyperdemocracy/usc-textversion huggingface dataset:
I 114th CONGRESS 1st Session H. R. 2426 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Shimkus introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices.

1. Easing regulatory burden with respect to certain class I and class II devices (a) Class I devices Section 510(l) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(l) ) is amended— (1) by striking A report under subsection (k) and inserting (1) A report under subsection (k) ; and (2) by adding at the end the following new paragraph: (2) Not later than 120 days after the date of the enactment of the 21st Century Cures Act , the Secretary shall identify, through publication in the Federal Register, any type of class I device that the Secretary determines no longer requires a report under subsection (k) to provide reasonable assurance of safety and effectiveness. Upon such publication— (A) each type of class I device so identified shall be exempt from the requirement for a report under subsection (k); and (B) the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption. . (b) Class II devices Section 510(m) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360(m) ) is amended— (1) by striking paragraph (1) and inserting the following new paragraph: (1) The Secretary shall— (A) not later than 60 days after the date of the enactment of the 21st Century Cures Act — (i) publish in the Federal Register a notice that contains a list of each type of class II device that the Secretary determines no longer requires a report under subsection (k) to provide reasonable assurance of safety and effectiveness; and (ii) provide for a period of not less than 60 days for public comment beginning on the date of the publication of such notice; and (B) not later than 180 days after the date of the enactment of 21st Century Cures Act , publish in the Federal Register a list representing the Secretary’s final determination with respect to the devices contained in the list published under subparagraph (A). ; (2) in paragraph (2)— (A) by striking 1 day after the date of publication of a list under this subsection, and inserting 1 day after the date of publication of the final list under paragraph (1)(B), ; and (B) by striking 30-day period and inserting 60-day period ; and (3) by adding at the end the following new paragraph: (3) Upon the publication of the final list under paragraph (1)(B)— (A) each type of class II device so listed shall be exempt from the requirement for a report under subsection (k); and (B) the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption. .
I 114th CONGRESS 1st Session H. R. 2427 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Shimkus introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to advisory committee process.

1. Advisory committee process (a) Classification panels Paragraph (5) of section 513(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c(b) ) is amended— (1) by striking (5) and inserting (5)(A) ; and (2) by adding at the end the following: (B) For review by a classification panel of a premarket submission for a device, the Secretary shall— (i) provide an opportunity for the person whose premarket submission is subject to panel review to provide recommendations on the expertise needed among the voting members of the panel; and (ii) give due consideration to such recommendations and ensure that adequate expertise is represented on advisory panels to assess— (I) the disease or condition for which the device is intended to cure, treat, mitigate, prevent, or diagnose; and (II) the technology of the device. (C) For purposes of subparagraph (B)(ii), the term adequate expertise means that the membership of the classification panel reviewing a premarket submission includes— (i) two or more voting members, with a specialty or other expertise clinically relevant to the device under review; and (ii) at least one voting member who is knowledgeable about the technology of the device. . (b) Panel review process Section 513(b)(6) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360c(b)(6) ) is amended— (1) in subparagraph (A)(iii), by inserting before the period at the end , including by designating a representative who will be provided a time during the panel meeting to address the panel individually (or accompanied by experts selected by such representative) for the purpose of correcting misstatements of fact or providing clarifying information, subject to the discretion of panel chairperson. . (2) by striking subparagraph (B) and inserting the following new subparagraph: (B) (i) Any meeting of a classification panel with respect to the review of a premarket submission for a device shall— (I) provide adequate time for initial presentations by the person whose premarket submission is specifically the subject of such review and by the Secretary; and (II) encourage free and open participation by all interested persons. (ii) Following the initial presentations described in clause (i), the panel may— (I) pose questions to a designated representative described in subparagraph (A)(iii); and (II) consider the responses to such questions in the panel’s review of the premarket submission. .
I 114th CONGRESS 1st Session H. R. 2428 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Shimkus introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.

1. Humanitarian device exemption application (a) In general Section 520(m) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j ) is amended— (1) in paragraph (1) by striking fewer than 4,000 and inserting not more than 8,000 ; (2) in paragraph (2)(A) by striking fewer than 4,000 and inserting not more than 8,000 ; and (3) in paragraph (6)(A)(ii), by striking 4,000 and inserting 8,000 . (b) Guidance document on probable benefit Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance document that defines the criteria for establishing probable benefit as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360j(m)(2)(C) ).
I 114th CONGRESS 1st Session H. R. 2429 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. McDermott (for himself, Mr. Blumenauer , Mr. Langevin , Ms. Kaptur , Mr. Rangel , Mr. Conyers , Ms. Norton , Mr. Vargas , Mr. DeFazio , Mr. Honda , Mr. DeSaulnier , Mr. Hastings , Ms. Brownley of California , Mr. Van Hollen , Ms. Moore , Mr. Rush , Mr. Meeks , Mr. Hinojosa , Ms. Clark of Massachusetts , Mr. Gutiérrez , Mr. Danny K. Davis of Illinois , Mrs. Capps , Mr. Cárdenas , Mr. Welch , Ms. Schakowsky , Mr. Larson of Connecticut , Mr. Doggett , Mr. McNerney , Mr. Larsen of Washington , Mr. Grijalva , Mr. Brendan F. Boyle of Pennsylvania , Mr. Cicilline , Mr. Cummings , Mr. Kind , and Mr. Smith of Washington ) introduced the following bill; which was referred to the Committee on Ways and Means A BILL 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) of the Internal Revenue Code of 1986 is amended to read as follows: (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.
I 114th CONGRESS 1st Session H. R. 2433 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Bilirakis introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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) ) is amended by adding at the end the following new clause: (iii) Not later than 18 months after the date of the enactment of the 21st Century Cures Act , the Secretary shall issue final guidance that describes the responsibilities of each agency center regarding its review of combination products. The Secretary shall, after soliciting public comment, review and update the guidance periodically. .
I 114th CONGRESS 1st Session H. R. 2434 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mrs. Black (for herself, Mr. Danny K. Davis of Illinois , Mr. McDermott , Mr. Franks of Arizona , Mr. Marino , Mr. Langevin , and Ms. Bass ) introduced the following bill; which was referred to the Committee on Ways and Means A BILL 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 and inserting 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) and inserting section 36C(c) , and (B) in subsection (e), by striking subsections (e), (f), and (g) of section 23 and inserting subsections (d), (e), and (f) of section 36C . (4) Section 1016(a)(26) is amended by striking 23(g) and inserting 36C(f) . (5) Section 6211(b)(4)(A) of such Code is amended by inserting 36C, before 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, after 36B, . (8) The table of sections for subpart C of part IV of subchapter A of chapter 1 of the Internal Revenue Code of 1986, as amended by this Act, is amended by inserting after the item relating to section 36B the following new item: Sec. 36C. Adoption expenses. . (c) Effective date The amendments made by this section shall apply to taxable years beginning after December 31, 2014.
I 114th CONGRESS 1st Session H. R. 2436 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mrs. Blackburn (for herself and Mrs. Capps ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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.
I 114th CONGRESS 1st Session H. R. 2437 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mrs. Blackburn introduced the following bill; which was referred to the Committee on Energy and Commerce , and in addition to the Committee on Ways and Means , for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned A BILL 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) ) is amended— (1) in the paragraph heading, by striking items and inserting items; prior authorization process for certain high cost durable medical equipment, prosthetics, orthotics, and supplies ; and (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. .
I 114th CONGRESS 1st Session H. R. 2438 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Collins of New York introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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 ) and biological products under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ), the Secretary shall conduct a public meeting and issue guidance in accordance with subsection (b). (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 ), shall— (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).
I 114th CONGRESS 1st Session H. R. 2439 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Collins of New York introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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 ) is amended— (1) in the section heading, by inserting and Biomedical Product Assessment after Research ; (2) in subsection (a)(1), by striking Silvio O. Conte Senior Biomedical Research Service, not to exceed 500 members and inserting Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service (in this section referred to as the Service ), the purpose of which is to recruit and retain competitive and qualified scientific and technical experts outstanding in the field of biomedical research, clinical research evaluation, and biomedical product assessment ; (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 and inserting , clinical research evaluation or biomedical product assessment after evaluation ; and (B) in paragraph (1), by inserting or a master's level degree in engineering, bioinformatics, or a related or emerging field, after the comma; (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 inserting 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.
I 114th CONGRESS 1st Session H. R. 2443 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Guthrie introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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 of the guidance entitled Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices and dated January 30, 2008; and (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.
I 114th CONGRESS 1st Session H. R. 2444 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Guthrie introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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 has the meaning given to such term in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ). (2) The term biological product has the meaning given to such term in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) ). (3) The term institution of higher education has the meaning given to such term in section 101 of the Higher Education Act of 1965 ( 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.
I 114th CONGRESS 1st Session H. R. 2445 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Guthrie introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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.
I 114th CONGRESS 1st Session H. R. 2446 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Guthrie introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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 ) is amended by inserting after subsection (k) the following new subsection: (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) furnished in such quarter, the Federal medical assistance percentage shall be reduced— (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 means a system under which visits conducted as part of personal care services specified under regulations under section 1905(a)(24) furnished under the State plan are electronically verified with respect to— (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) ) under a State plan under title XIX of the Social Security Act and the individuals who, under a contract with such an agency or entity, furnish such services for purposes of part 552 of title 29, Code of Federal Regulations (or any successor regulations).
I 114th CONGRESS 1st Session H. R. 2448 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Harris introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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. ) is amended by adding at the end the following: 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. .
I 114th CONGRESS 1st Session H. R. 2452 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Long (for himself, Mr. Schrader , and Mr. Burgess ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to facilitating dissemination of health care economic information.

1. Facilitating dissemination of health care economic information Section 502(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 352(a) ) is amended— (1) by striking (a) If its and inserting (a)(1) If its ; (2) by striking a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations and inserting a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement ; (3) by striking directly relates and inserting relates ; (4) by striking and is based on competent and reliable scientific evidence. The requirements set forth in section 505(a) or in section 351(a) of the Public Health Service Act shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph and inserting , is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug under section 505 or under section 351 of the Public Health Service Act. The requirements set forth in section 505(a) or in subsections (a) and (k) of section 351 of the Public Health Service Act shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph ; and (5) by striking In this paragraph, the term and all that follows and inserting the following: (2) (A) For purposes of this paragraph, the term health care economic information means any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug. Such analyses may be comparative to the use of another drug, to another health care intervention, or to no intervention. (B) Such term does not include any analysis that relates only to an indication that is not approved under section 505 or under section 351 of the Public Health Service Act for such drug. .
I 114th CONGRESS 1st Session H. R. 2455 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Pitts introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to precision medicine.

1. Precision medicine guidance and other programs of Food and Drug Administration Chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. ) is amended by adding at the end the following: J Precision Medicine 591. General agency guidance on precision medicine (a) In general The Secretary shall issue and periodically update guidance to assist sponsors in the development of a precision drug or biological product. Such guidance shall— (1) define the term precision drug or biological product ; and (2) address the topics described in subsection (b). (b) Certain issues The topics to be addressed by guidance under subsection (a) are— (1) the evidence needed to support the use of biomarkers (as defined in section 507(e)) that identify subsets of patients as likely responders to therapies in order to streamline the conduct of clinical trials; (2) recommendations for the design of studies to demonstrate the validity of a biomarker as a predictor of drug or biological product response; (3) the manner and extent to which a benefit-risk assessment may be affected when clinical trials are limited to patient population subsets that are identified using biomarkers; (4) the development of companion diagnostics in the context of a drug development program; and (5) considerations for developing biomarkers that aid prescribing decisions for a drug or biological product, and when information regarding a biomarker may be included in the labeling for a drug or biological product approved under section 505 of this Act or section 351 of the Public Health Service Act. (c) Date certain for initial guidance The Secretary shall issue guidance under subsection (a) not later than 18 months after the date of the enactment of the 21st Century Cures Act. 592. Precision medicine regarding orphan-drug and expedited-approval programs In the case of an application for a precision drug or biological product under section 505(b)(1), or section 351(a) of the Public Health Service Act, that has been designated under section 526 as a drug for a rare disease for a serious condition, the Secretary may— (1) consistent with applicable standards for approval, rely upon data or information previously developed by the sponsor of the precision drug or biological product for a prior approved drug or indication (or that of another sponsor, provided the sponsor of the precision drug or biological product has obtained a contractual right of reference to such other sponsor’s data and information) in order to expedite clinical development for a precision drug or indication that is using the same or similar approach as that of the prior approved drug or indication; and (2) as appropriate under section 506, consider the application for approval of such precision drug or biological product to be eligible for expedited review, including under section 506(c) (relating to accelerated approval). .
I 114th CONGRESS 1st Session H. R. 2456 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Pitts introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Public Health Service Act to ensure the sharing of data generated from research with the public.

1. Sharing of data generated through NIH-funded research Section 402 of the Public Health Service Act ( 42 U.S.C. 282 ) is amended by adding at the end the following: (m) Sharing of data generated through NIH-Funded research (1) Authority Subject to paragraph (2), the Director of NIH may require recipients of the award of an NIH grant or other financial support, provided that the research is fully funded through such grant or other support, to share scientific data generated from research conducted through such support for research purposes. (2) Limitation The Director of NIH shall not require the sharing of data that is inconsistent with applicable law and policy protecting— (A) privacy and confidentiality; (B) proprietary interests; (C) business confidential information; (D) intellectual property rights; and (E) other relevant rights. .
I 114th CONGRESS 1st Session H. R. 2457 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Ms. Plaskett introduced the following bill; which was referred to the Committee on Ways and Means A BILL To amend the Internal Revenue Code of 1986 to allow the work opportunity credit to small businesses which hire individuals who are members of the Ready Reserve or National Guard, and for other purposes.

1. Short title This Act may be cited as the Hire A Hero Act of 2015 . 2. Work opportunity credit to small businesses for hiring members of Ready Reserve or National Guard (a) In general Section 51(d)(1) of the Internal Revenue Code of 1986 is amended by striking or at the end of subparagraph (H), by striking the period at the end of subparagraph (I) and inserting , or , and by adding at the end the following new subparagraph: (J) in the case of an eligible employer (as defined in section 408(p)(2)(C)(i)), an individual who is a member of— (i) the Ready Reserve (as described in section 10142 of title 10, United States Code), or (ii) the National Guard (as defined in section 101(c)(1) of such title 10). . (b) Effective date (1) In general The amendment made by this section shall apply to wages paid or incurred after the date of the enactment of this Act in taxable years ending after such date. (2) Current employees covered by credit For purposes of applying section 51 of the Internal Revenue Code of 1986, individuals described in section 51(d)(1)(J) of such Code, as added by this section, who are employed by an eligible employer (as defined in section 408(p)(2)(C)(i) of such Code) on the date of the enactment of this Act shall be treated as beginning work for such employer on such date. 3. Permanent extension of work opportunity credit for employers hiring qualified veterans and members of Ready Reserve and National Guard (a) In general Section 51(c)(4) of the Internal Revenue Code of 1986 is amended by inserting (other than any individual described in subparagraph (B) or (J) of subsection (d)(1)) after individual . (b) Effective date The amendment made by this section shall apply to individuals who begin work for the employer after December 31, 2014.
I 114th CONGRESS 2d Session H. R. 2458 IN THE HOUSE OF REPRESENTATIVES AN ACT To designate the facility of the United States Postal Service located at 5351 Lapalco Boulevard in Marrero, Louisiana, as the Lionel R. Collins, Sr. Post Office Building .

1. Lionel R. Collins, Sr. Post Office Building (a) Designation The facility of the United States Postal Service located at 5351 Lapalco Boulevard in Marrero, Louisiana, shall be known and designated as the Lionel R. Collins, Sr. Post Office Building . (b) References Any reference in a law, map, regulation, document, paper, or other record of the United States to the facility referred to in subsection (a) shall be deemed to be a reference to the Lionel R. Collins, Sr. Post Office Building .

Passed the House of Representatives March 1, 2016. Karen L. Haas, Clerk.
I One Hundred Fourteenth Congress of the United States of America At the Second Session Begun and held at the City of Washington on Monday, the fourth day of January, two thousand and sixteen H. R. 2458 AN ACT To designate the facility of the United States Postal Service located at 5351 Lapalco Boulevard in Marrero, Louisiana, as the Lionel R. Collins, Sr. Post Office Building .

1. Lionel R. Collins, Sr. Post Office Building (a) Designation The facility of the United States Postal Service located at 5351 Lapalco Boulevard in Marrero, Louisiana, shall be known and designated as the Lionel R. Collins, Sr. Post Office Building . (b) References Any reference in a law, map, regulation, document, paper, or other record of the United States to the facility referred to in subsection (a) shall be deemed to be a reference to the Lionel R. Collins, Sr. Post Office Building .

Speaker of the House of Representatives. Vice President of the United States and President of the Senate.
I 114th CONGRESS 1st Session H. R. 2458 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Richmond (for himself and Mr. Scalise ) introduced the following bill; which was referred to the Committee on Oversight and Government Reform A BILL To designate the facility of the United States Postal Service located at 5351 Lapalco Boulevard in Marrero, Louisiana, as the Lionel R. Collins, Sr. Post Office Building .

1. Lionel R. Collins, Sr. Post Office Building (a) Designation The facility of the United States Postal Service located at 5351 Lapalco Boulevard in Marrero, Louisiana, shall be known and designated as the Lionel R. Collins, Sr. Post Office Building . (b) References Any reference in a law, map, regulation, document, paper, or other record of the United States to the facility referred to in subsection (a) shall be deemed to be a reference to the Lionel R. Collins, Sr. Post Office Building .
IIB 114th CONGRESS 2d Session H. R. 2458 IN THE SENATE OF THE UNITED STATES March 2, 2016 Received; read twice and referred to the Committee on Homeland Security and Governmental Affairs AN ACT To designate the facility of the United States Postal Service located at 5351 Lapalco Boulevard in Marrero, Louisiana, as the Lionel R. Collins, Sr. Post Office Building .

1. Lionel R. Collins, Sr. Post Office Building (a) Designation The facility of the United States Postal Service located at 5351 Lapalco Boulevard in Marrero, Louisiana, shall be known and designated as the Lionel R. Collins, Sr. Post Office Building . (b) References Any reference in a law, map, regulation, document, paper, or other record of the United States to the facility referred to in subsection (a) shall be deemed to be a reference to the Lionel R. Collins, Sr. Post Office Building .

Passed the House of Representatives March 1, 2016. Karen L. Haas, Clerk
II Calendar No. 490 114th CONGRESS 2d Session H. R. 2458 IN THE SENATE OF THE UNITED STATES March 2, 2016 Received; read twice and referred to the Committee on Homeland Security and Governmental Affairs May 25, 2016 Reported by Mr. Johnson , without amendment AN ACT To designate the facility of the United States Postal Service located at 5351 Lapalco Boulevard in Marrero, Louisiana, as the Lionel R. Collins, Sr. Post Office Building .

1. Lionel R. Collins, Sr. Post Office Building (a) Designation The facility of the United States Postal Service located at 5351 Lapalco Boulevard in Marrero, Louisiana, shall be known and designated as the Lionel R. Collins, Sr. Post Office Building . (b) References Any reference in a law, map, regulation, document, paper, or other record of the United States to the facility referred to in subsection (a) shall be deemed to be a reference to the Lionel R. Collins, Sr. Post Office Building .

May 25, 2016 Reported without amendment
I 114th CONGRESS 2d Session H. R. 2460 IN THE HOUSE OF REPRESENTATIVES AN ACT To amend title 38, United States Code, to improve the provision of adult day health care services for veterans.

1. Provision of adult day health care services for veterans (a) In general Section 1745 of title 38, United States Code, is amended— (1) by adding at the end the following new subsection: (d) (1) The Secretary shall enter into an agreement under section 1720(c)(1) of this title or a contract with each State home for payment by the Secretary for adult day health care provided to a veteran who is eligible for, but does not receive, nursing home care pursuant to subsection (a). (2) Payment under each agreement or contract between the Secretary and a State home under paragraph (1) for each veteran who receives care under such paragraph shall be made at a rate that is equal to 65 percent of the payment that the Secretary would pay to the State home pursuant to subsection (a)(2) if the veteran received nursing home care under subsection (a) rather than under paragraph (1) of this subsection. (3) Payment by the Secretary under paragraph (1) to a State home for adult day health care provided to a veteran described in that paragraph constitutes payment in full to the State home for such care furnished to that veteran. ; and (2) in the heading, by inserting , adult day health care, after home care . (b) clerical amendment The table of sections at the beginning of chapter 17 of such title is amended by striking the item relating to section 1745 and inserting the following new item: 1745. Nursing home care, adult day health care, and medications for veterans with service-connected disabilities. .

Passed the House of Representatives May 23, 2016. Karen L. Haas, Clerk.
I 114th CONGRESS 1st Session H. R. 2460 IN THE HOUSE OF REPRESENTATIVES May 19, 2015 Mr. Zeldin introduced the following bill; which was referred to the Committee on Veterans’ Affairs A BILL To amend title 38, United States Code, to improve the provision of adult day health care services for veterans.

1. Provision of adult day health care services for veterans (a) In general Section 1745 of title 38, United States Code, is amended— (1) by adding at the end the following new subsection: (d) (1) The Secretary shall enter into an agreement under section 1720(c)(1) of this title or a contract with each State home for payment by the Secretary for adult day health care provided to a veteran who is eligible for, but does not receive, nursing home care pursuant to subsection (a). (2) Payment under each agreement or contract between the Secretary and a State home under paragraph (1) for each veteran who receives care under such paragraph shall be made at a rate that is equal to 65 percent of the payment that the Secretary would pay to the State home pursuant to subsection (a)(2) if the veteran received nursing home care under subsection (a) rather than under paragraph (1) of this subsection. (3) Payment by the Secretary under paragraph (1) to a State home for adult day health care provided to a veteran described in that paragraph constitutes payment in full to the State home for such care furnished to that veteran. ; and (2) in the heading, by inserting , adult day health care, after home care . (b) clerical amendment The table of sections at the beginning of chapter 17 of such title is amended by striking the item relating to section 1745 and inserting the following new item: 1745. Nursing home care, adult day health care, and medications for veterans with service-connected disabilities. .
IIB 114th CONGRESS 2d Session H. R. 2460 IN THE SENATE OF THE UNITED STATES May 24, 2016 Received; read twice and referred to the Committee on Veterans' Affairs AN ACT To amend title 38, United States Code, to improve the provision of adult day health care services for veterans.

1. Provision of adult day health care services for veterans (a) In general Section 1745 of title 38, United States Code, is amended— (1) by adding at the end the following new subsection: (d) (1) The Secretary shall enter into an agreement under section 1720(c)(1) of this title or a contract with each State home for payment by the Secretary for adult day health care provided to a veteran who is eligible for, but does not receive, nursing home care pursuant to subsection (a). (2) Payment under each agreement or contract between the Secretary and a State home under paragraph (1) for each veteran who receives care under such paragraph shall be made at a rate that is equal to 65 percent of the payment that the Secretary would pay to the State home pursuant to subsection (a)(2) if the veteran received nursing home care under subsection (a) rather than under paragraph (1) of this subsection. (3) Payment by the Secretary under paragraph (1) to a State home for adult day health care provided to a veteran described in that paragraph constitutes payment in full to the State home for such care furnished to that veteran. ; and (2) in the heading, by inserting , adult day health care, after home care . (b) clerical amendment The table of sections at the beginning of chapter 17 of such title is amended by striking the item relating to section 1745 and inserting the following new item: 1745. Nursing home care, adult day health care, and medications for veterans with service-connected disabilities. .

Passed the House of Representatives May 23, 2016. Karen L. Haas, Clerk