Newborn Screening Saves Lives Reauthorization Act of 2014

To amend the Public Health Service Act to reauthorize programs under part A of title XI of such Act. 1. Short title; table of contents (a) Short title This Act may be cited as the Newborn Screening Saves Lives Reauthorization Act of 2014 (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Improved newborn and child screening and followup for heritable disorders. Sec. 3. Evaluating the effectiveness of newborn and child screening and followup programs. Sec. 4. Advisory Committee on Heritable Disorders in Newborns and Children. Sec. 5. Clearinghouse of Newborn Screening Information. Sec. 6. Laboratory quality and surveillance. Sec. 7. Interagency Coordinating Committee on Newborn and Child Screening. Sec. 8. National contingency plan for newborn screening. Sec. 9. Hunter Kelly Research Program. Sec. 10. Authorization of appropriations. Sec. 11. Reports to Congress. 2. Improved newborn and child screening and followup for heritable disorders Section 1109 of the Public Health Service Act ( 42 U.S.C. 300b–8 (1) in subsection (a)— (A) in the matter preceding paragraph (1)— (i) by striking subsection (j) section 1117 (ii) by striking and in consultation with the Advisory Committee and taking into consideration the expertise of the Advisory Committee (B) by amending paragraph (2) to read as follows: (2) to assist in providing health care professionals and newborn screening laboratory personnel with education in newborn screening, counseling, and training in— (A) relevant and new technologies in newborn screening and congenital, genetic, and metabolic disorders; (B) the importance of the timeliness of collection, delivery, receipt, and screening of specimens; and (C) sharing of medical and diagnostic information with providers and families; ; (C) in paragraph (3), by striking and (D) in paragraph (4)— (i) by striking treatment followup and treatment (ii) by striking the period and inserting ; and (E) by adding at the end the following: (5) to improve the timeliness of— (A) the collection, delivery, receipt, and screening of specimens; and (B) the diagnosis of heritable disorders in newborns. ; (2) in subsection (c), by striking application submitted for a grant under subsection (a)(1) application for a grant under this section (3) in subsection (h), by striking application submitted under subsection (c)(2) application for a grant under this section (4) by striking subsection (j) (relating to authorization of appropriations). 3. Evaluating the effectiveness of newborn and child screening and followup programs Section 1110 of the Public Health Service Act ( 42 U.S.C. 300b–9 (1) in the section heading, by inserting and followup child screening (2) in subsection (a), by striking of screening, , including with respect to timeliness, of screening, followup, (3) in subsection (b)— (A) in paragraph (1)— (i) by striking counseling, testing treatment, counseling, testing, followup, (ii) by inserting before the semicolon the following: , including, as appropriate, through the assessment of health and development outcomes for such children through adolescence (B) in paragraph (2)— (i) by striking counseling, testing treatment, counseling, testing, followup, (ii) by inserting in a timely manner in newborns and children (iii) by striking or (C) in paragraph (3), by striking the period at the end and inserting a semicolon; and (D) by adding at the end the following: (4) methods that may be identified to improve quality in the diagnosis, treatment, and disease management of heritable disorders based on gaps in services or care; or (5) methods or best practices by which the eligible entities described in section 1109 can achieve in a timely manner— (A) collection, delivery, receipt, and screening of newborn screening specimens; and (B) diagnosis of heritable disorders in newborns. ; and (4) by striking subsection (d) (relating to authorization of appropriations). 4. Advisory Committee on Heritable Disorders in Newborns and Children Section 1111 of the Public Health Service Act ( 42 U.S.C. 300b–10 (1) in subsection (b)— (A) by redesignating paragraphs (4) through (6) as paragraphs (6) through (8), respectively; (B) by inserting after paragraph (3), the following: (4) provide technical assistance, as appropriate, to individuals and organizations regarding the submission of nominations to the uniform screening panel, including prior to the submission of such nominations; (5) take appropriate steps, at its discretion, to prepare for the review of nominations prior to their submission, including for conditions for which a screening method has been validated but other nomination criteria are not yet met, in order to facilitate timely action by the Advisory Committee once such submission has been received by the Committee; ; (C) in paragraph (6) (as so redesignated), by inserting , including the cost public health impact (D) in paragraph (8) (as so redesignated)— (i) in subparagraph (A), by striking achieve rapid diagnosis achieve best practices in rapid diagnosis and appropriate treatment (ii) in subparagraph (D), by inserting before the semicolon , including information on cost and incidence (iii) in subparagraph (J), by striking and (iv) in subparagraph (K), by striking the period and inserting ; and (v) by adding at the end the following: (L) the timeliness of collection, delivery, receipt, and screening of specimens to be tested for heritable disorders in newborns in order to ensure rapid diagnosis and followup. ; (2) in subsection (d)— (A) in paragraph (1)— (i) by striking 180 120 (ii) by adding at the end the following: If the Secretary is unable to make a determination to adopt or reject such recommendation within such 120-day period, the Secretary shall notify the Advisory Committee and the appropriate committees of Congress of such determination together with an explanation for why the Secretary was unable to comply within such 120-day period, as well as a plan of action for consideration of such pending recommendation. (B) by striking paragraph (2); (C) by redesignating paragraph (3) as paragraph (2); and (D) by adding at the end the following: (3) Deadline for review For each condition nominated to be added to the recommended uniform screening panel in accordance with the requirements of this section, the Advisory Committee shall review and vote on the nominated condition within 9 months of the date on which the Advisory Committee referred the nominated condition to the condition review workgroup. ; (3) by redesignating subsections (f) and (g) as subsections (g) and (h), respectively; (4) by inserting after subsection (e) the following new subsection: (f) Meetings The Advisory Committee shall meet at least 4 times each calendar year, or at the discretion of the Designated Federal Officer in consultation with the Chair. ; (5) by amending subsection (g) (as so redesignated) to read as follows: (g) Continuation of operation of committee (1) In general Notwithstanding section 14 of the Federal Advisory Committee Act, the Advisory Committee shall continue to operate through the end of fiscal year 2019. (2) Continuation if not reauthorized If at the end of fiscal year 2019 the duration of the Advisory Committee has not been extended by statute, the Advisory Committee may be deemed, for purposes of the Federal Advisory Committee Act, an advisory committee established by the President or an officer of the Federal Government under section 9(a) of such Act. ; and (6) by striking subsection (h) (relating to authorization of appropriations), as redesignated by paragraph (3). 5. Clearinghouse of Newborn Screening Information Section 1112 of the Public Health Service Act ( 42 U.S.C. 300b–11 (1) in subsection (a)— (A) in paragraph (2), by striking and (B) in paragraph (3)— (i) by striking data information (ii) by striking the period at the end and inserting a semicolon; and (C) by adding at the end the following new paragraphs: (4) maintain current information on the number of conditions for which screening is conducted in each State; and (5) disseminate available evidence-based guidelines related to diagnosis, counseling, and treatment with respect to conditions detected by newborn screening. ; (2) in subsection (b)(4)(D), by striking Newborn Screening Saves Lives Act of 2008 Newborn Screening Saves Lives Reauthorization Act of 2014 (3) in subsection (c)— (A) by striking developing the clearinghouse carrying out activities (B) by striking clearinghouse minimizes duplication and supplements, not supplants activities minimize duplication and supplement, not supplant (4) by striking subsection (d) (relating to authorization of appropriations). 6. Laboratory quality and surveillance Section 1113 of the Public Health Service Act ( 42 U.S.C. 300b–12 (1) in the section heading, by inserting and surveillance (2) in subsection (a)— (A) in the matter preceding paragraph (1), by striking and in consultation with the Advisory Committee and taking into consideration the expertise of the Advisory Committee (B) in paragraph (1), by inserting timeliness for processing such tests, newborn-screening tests, (3) by striking subsection (b) (relating to authorization of appropriations) and inserting the following: (b) Surveillance activities The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in Newborns and Children established under section 1111, may provide, as appropriate, for the coordination of surveillance activities, including— (1) through standardized data collection and reporting, as well as the use of electronic health records; and (2) by promoting data sharing regarding newborn screening with State-based birth defects and developmental disabilities monitoring programs. . 7. Interagency Coordinating Committee on Newborn and Child Screening Section 1114 of the Public Health Service Act ( 42 U.S.C. 300b–13 (1) in subsection (c), by striking the Administrator, the Director of the Agency for Healthcare Research and Quality, the Administrator of the Health Resources and Services Administration, the Director of the Agency for Healthcare Research and Quality, the Commissioner of Food and Drugs, (2) by striking subsection (e) (relating to authorization of appropriations). 8. National contingency plan for newborn screening Section 1115(a) of the Public Health Service Act ( 42 U.S.C. 300b–14(a) (1) by striking consortia consortium (2) by adding at the end the following: The plan shall be updated as needed and at least every five years. 9. Hunter Kelly Research Program Section 1116 of the Public Health Service Act ( 42 U.S.C. 300b–15 (1) in subsection (a)(1)— (A) in subparagraph (B), by striking ; and (B) by redesignating subparagraph (C) as subparagraph (E); and (C) by inserting after subparagraph (B) the following: (C) providing research findings and data for newborn conditions under review by the Advisory Committee on Heritable Disorders in Newborns and Children to be added to the recommended uniform screening panel; (D) conducting pilot studies on conditions recommended by the Advisory Committee on Heritable Disorders in Newborns and Children to ensure that screenings are ready for nationwide implementation; and ; and (2) in subsection (c), by striking of the National Institutes of Health Reform Act of 2006 10. Authorization of appropriations Part A of title XI of the Public Health Service Act ( 42 U.S.C. 300b–1 et seq. 1117. Authorization of appropriations for newborn screening programs and activities There are authorized to be appropriated— (1) to carry out sections 1109, 1110, 1111, and 1112, $11,900,000 for each of fiscal years 2015 through 2019; and (2) to carry out section 1113, $8,000,000 for each of fiscal years 2015 through 2019. . 11. Reports to Congress (a) GAO report on timeliness of newborn screening (1) In general Not later than 2 years after the date of enactment of this Act, the Comptroller General of the United States shall submit a report to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives concerning the timeliness of screening for heritable disorders in newborns. (2) Contents The report submitted under paragraph (1) shall include the following: (A) An analysis of information regarding the timeliness of newborn screening, which may include the time elapsed from birth to specimen collection, specimen collection to receipt by laboratory, specimen receipt to reporting, reporting to followup testing, and followup testing to confirmed diagnosis. (B) A summary of any guidelines, recommendations, or best practices available to States and health care providers intended to support a timely newborn screening system. (C) An analysis of any barriers to maintaining a timely newborn screening system which may exist and recommendations for addressing such barriers. (b) Report by Secretary (1) In general The Secretary of Health and Human Services shall— (A) not later than 1 year after the date of enactment of this Act, submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report on activities related to— (i) newborn screening; and (ii) screening children who have or are at risk for heritable disorders; and (B) not less than every 2 years, submit to such committees an updated version of such report. (2) Contents The report submitted under this subsection shall contain a description of— (A) the ongoing activities under sections 1109, 1110, and 1112 through 1115 of the Public Health Service Act; and (B) the amounts expended on such activities. June 19, 2014 Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed

Summary: (This measure has not been amended since it was passed by the Senate on December 8, 2014. The summary of that version is repeated here.) Newborn Screening Saves Lives Reauthorization Act of 2014 - (Sec. 2) Amends the Public Health Service Act to revise and extend through FY2019 a grant program for screening, counseling, and other services related to heritable disorders that can be detected in newborns. Allows grants to be used to improve timeliness of newborn screening and provide training to health care professionals on the importance of timely screening and on the sharing of medical and diagnostic information with providers and families. (Sec. 3) Extends through FY2019 a grant program to evaluate the effectiveness of screening, counseling, or health care services in reducing the morbidity and mortality caused by heritable disorders in newborns and children. Expands the program to include evaluation of health outcomes through adolescence and best practices for timely screening of newborns. (Sec. 4) Extends for five years the operation of the Advisory Committee on Heritable Disorders in Newborns and Children. Authorizes the Secretary of Health and Human Services (HHS) to continue the Advisory Committee after such time. (Sec. 5) Extends through FY2019 the clearinghouse for newborn screening information. Expands the duties of the clearinghouse to include: (1) maintaining current information on the number of conditions for which screening is conducted in each state; and (2) disseminating guidelines for diagnosis, counseling, and treatment of conditions detected by newborn screening. (Sec. 6) Extends through FY2019 requirements for the Director of the Centers for Disease Control and Prevention (CDC) to provide for quality assurance of laboratories involved in screening newborns and children for heritable disorders. Authorizes the Director to coordinate surveillance activities, including through standardized data collection and reporting and electronic health records. (Sec. 7) Makes permanent the Interagency Coordinating Committee on Newborn and Child Screening. Adds the Administrator of the Health Resources and Services Administration and the Commissioner of Food and Drugs (FDA) to this committee. (Sec. 8) Requires the Director to update the national contingency plan for newborn screening at least every five years. (Sec. 9) Authorizes the Secretary to expand the Hunter Kelly Newborn Screening Research Program to: (1) provide research and data for newborn conditions under review by the Advisory Committee to be added to the Recommended Uniform Screening Panel, and (2) conduct pilot studies on conditions recommended by the Advisory Committee to ensure that screenings are ready for nationwide implementation. (Sec. 11) Requires the Comptroller General (GAO) to report on the timeliness of newborn screening. Requires the Secretary to report on newborn screening activities and expenditures. (Sec. 12) Directs HHS to update the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, not later than two years after enactment of this Act. Applies the following provisions until HHS updates the Common Rule: requires federally funded research on newborn dried blood spots to be considered research on human subjects (which requires the informed consent of the subject), and eliminates the ability of an institutional review board to waive informed consent requirements for research on newborn dried blood spots.