Newborn Screening Saves Lives Reauthorization Act of 2014

Bill: 113-hr-1281
Sponsor: full_name: Rep. Roybal-Allard, Lucille [D-CA-40]
Introduced: 2013-03-20
Policy area: Health
Subjects: Advisory bodies

Child health

Congressional oversight

Executive agency funding and structure

Genetics

Health information and medical records

Health programs administration and funding

Health promotion and preventive care

Hereditary and development disorders

Medical research

Medical tests and diagnostic methods

Research administration and funding
Latest action: action_date: 2014-12-18
text: Became Public Law No: 113-240.

Summaries:
action_date: 2013-03-20
action_desc: Introduced in House
text: <p>Newborn Screening Saves Lives Reauthorization Act of 2013 - Amends the Public Health Service Act to extend and revise a grant program for screening, counseling, and other services related to heritable disorders. Expands eligible grantees to include a health professional organization and an early childhood health system.</p> <p>Extends 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 treatment and follow-up care for newborns and their families after screening and diagnosis.</p> <p>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. Requires the Advisory Committee to meet in person at least twice each year.</p> <p>Extends the clearinghouse for newborn screening information. Expands the duties of the clearinghouse to include: (1) maintaining current data on the number of conditions for which screening is conducted in each state; and (2) establishing or disseminating guidelines for services and personnel necessary for follow-up, diagnosis, counseling, and treatment of to conditions detected by newborn screening.</p> <p>Extends requirements for the Secretary to provide for quality assurance of laboratories involved in screening newborns and children for heritable disorders.</p> <p>Extends the Interagency Coordinating Committee on Newborn and Child Screening.</p> <p>Authorizes the Secretary to have 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.</p> <p>Directs the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to award grants to, or enter into cooperative agreements with, eligible entities to develop longitudinal followup and tracking programs for newborn screening.</p>

action_date: 2014-06-19
action_desc: Reported to House with amendment(s)
text: <p>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. </p> <p>(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.</p> <p>(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. </p> <p>(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.</p> <p>(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.</p> <p>(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. </p> <p>(Sec. 8) Requires the Director to update the national contingency plan for newborn screening at least every five years.</p> <p>(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.</p> <p>(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.</p>

action_date: 2014-06-24
action_desc: Passed House amended
text: <p><b>(This measure has not been amended since it was reported to the House on June 19, 2014. The summary of that version is repeated here.)</b></p> <p>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. </p> <p>(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.</p> <p>(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. </p> <p>(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.</p> <p>(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.</p> <p>(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. </p> <p>(Sec. 8) Requires the Director to update the national contingency plan for newborn screening at least every five years.</p> <p>(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.</p> <p>(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.</p>

action_date: 2014-12-08
action_desc: Passed Senate amended
text: <p>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. </p> <p>(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.</p> <p>(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. </p> <p>(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.</p> <p>(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.</p> <p>(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. </p> <p>(Sec. 8) Requires the Director to update the national contingency plan for newborn screening at least every five years.</p> <p>(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.</p> <p>(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.</p> <p>(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:</p> <ul> <li>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</li> <li>eliminates the ability of an institutional review board to waive informed consent requirements for research on newborn dried blood spots. </li> </ul>

action_date: 2014-12-18
action_desc: Public Law
text: <p><b>(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.)</b></p> <p>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. </p> <p>(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.</p> <p>(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. </p> <p>(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.</p> <p>(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.</p> <p>(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. </p> <p>(Sec. 8) Requires the Director to update the national contingency plan for newborn screening at least every five years.</p> <p>(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.</p> <p>(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.</p> <p>(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:</p> <ul> <li>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</li> <li>eliminates the ability of an institutional review board to waive informed consent requirements for research on newborn dried blood spots. </li> </ul>

tv_txt: I 113th CONGRESS 1st Session H. R. 1281 IN THE HOUSE OF REPRESENTATIVES March 20, 2013 Ms. Roybal-Allard (for herself and Mr. Simpson ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL 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 2013 . (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 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. 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. Newborn screening surveillance, followup, and applied research. Sec. 11. Authorization of appropriations. 2. Improved newborn and child screening for heritable disorders Section 1109 of the Public Health Service Act ( 42 U.S.C. 300b–8 ) is amended— (1) in subsection (a)— (A) in the matter preceding paragraph (1), by striking and in consultation with the Advisory Committee and inserting and taking into consideration the recommendations of the Advisory Committee ; (B) in paragraph (2), by striking screening and training and inserting screening, counseling, and training ; and (C) in paragraph (4), by striking treatment and inserting followup and treatment ; (2) in subsection (b)— (A) in paragraph (4), by striking or at the end; (B) by redesignating paragraph (5) as paragraph (7); and (C) by inserting after paragraph (4) the following: (5) a health professional organization; (6) an early childhood health system; or ; and (3) 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 ) is amended— (1) in the section heading, by inserting and followup after child screening ; (2) in subsection (a), by inserting followup, after the effectiveness of screening, ; (3) in subsection (b)— (A) in paragraph (1), by inserting ascertainment, treatment, after the effectiveness of screening, counseling, ; (B) in paragraph (2)— (i) by inserting ascertainment, treatment, after the effectiveness of screening, counseling, ; and (ii) by striking or at the end; (C) in paragraph (3), by striking the period at the end and inserting ; or ; and (D) by adding at the end the following: (4) the availability and effectiveness of treatment and followup care for newborns and their families after screening and diagnosis. ; 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 ) is amended— (1) in subsection (b)— (A) in paragraph (4), by striking public health impact and inserting public health impact and cost ; and (B) in paragraph (6)— (i) in subparagraph (A), by striking achieve rapid diagnosis and inserting achieve best practices in rapid diagnosis and appropriate treatment ; and (ii) in subparagraph (D), by inserting before the semicolon , including information on cost and incidence ; (2) by redesignating subsections (f) and (g) as subsections (g) and (h), respectively; (3) by inserting after subsection (e) the following new subsection: (f) Meetings The Advisory Committee shall meet in person at least twice each year. ; (4) by amending subsection (g), as redesignated by paragraph (2), to read as follows: (g) Continuation of operation of committee (1) In general Notwithstanding section 14 of the Federal Advisory Committee Act (5 U.S.C. App.), the Advisory Committee shall continue to operate for the period beginning on the date of enactment of the Newborn Screening Saves Lives Reauthorization Act of 2013 and concluding at the end of the fifth fiscal year which begins after such date. (2) Continuation if not reauthorized If at the end of the fifth fiscal year described in paragraph (1) the duration of the Advisory Committee has not been extended by statute— (A) the Advisory Committee may be considered, for the purposes of the Federal Advisory Committee Act, to be an advisory committee established by the President or an officer of the Federal Government under section 9(a) of such Act; and (B) the Secretary may renew the Advisory Committee under section 14(a)(1)(A) of such Act. ; and (5) by striking subsection (h) (relating to authorization of appropriations), as redesignated by paragraph (2). 5. Clearinghouse of Newborn Screening Information Section 1112 of the Public Health Service Act ( 42 U.S.C. 300b–11 ) is amended— (1) in subsection (a)— (A) in paragraph (2), by striking ; and and inserting a semicolon; (B) in paragraph (3), 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 data on the number of conditions for which screening is conducted in each State; and (5) establish or disseminate guidelines for services and personnel necessary for followup, 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 and inserting Newborn Screening Saves Lives Reauthorization Act of 2013 ; and (3) by striking subsection (d) (relating to authorization of appropriations). 6. Laboratory quality Section 1113 of the Public Health Service Act ( 42 U.S.C. 300b–12 ) is amended— (1) in subsection (a)— (A) by striking the subsection enumerator and heading; and (B) by striking and in consultation with the Advisory Committee and inserting and taking into consideration the recommendations of the Advisory Committee ; and (2) by striking subsection (b) (relating to authorization of appropriations). 7. Interagency Coordinating Committee on Newborn and Child Screening Section 1114 of the Public Health Service Act ( 42 U.S.C. 300b–13 ) is amended— (1) in subsection (c), by striking the Administrator, the Director of the Agency for Healthcare Research and Quality and inserting 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, ; and (2) by striking subsection (e) (relating to authorization of appropriations) and inserting the following: (e) Report to congress (1) In general The Secretary shall— (A) not later than 1 year after the date of enactment of the Newborn Screening Saves Lives Reauthorization Act of 2013, submit to the Health, Education, Labor, and Pensions Committee of the Senate and the Energy and Commerce Committee 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, shall submit to such committees an updated version of such report. (2) Contents The report submitted under subsection (a) shall contain a description of— (A) the implementation of sections 1111 through 1116B, including this section; and (B) the amounts expended on such implementation. . 8. National contingency plan for newborn screening Section 1115(a) of the Public Health Service Act ( 42 U.S.C. 300b–14(a) ) is amended 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(a)(1) of the Public Health Service Act ( 42 U.S.C. 300b–15(a)(1) ) is amended— (1) in subparagraph (B), by striking ; and and inserting a semicolon; (2) by redesignating subparagraph (C) as subparagraph (E); and (3) by inserting after subparagraph (B) the following: (C) providing research 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 . 10. Newborn screening surveillance, followup, and applied research The Public Health Service Act is amended by inserting after section 1116 of such Act ( 42 U.S.C. 300b–15 ) the following: 1116A. Newborn screening surveillance, followup, and applied research (a) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall award grants to, or enter into cooperative agreements with, eligible entities to develop longitudinal followup and tracking programs for newborn screening. (b) Program Longitudinal followup and tracking programs developed through a grant under subsection (a) shall incorporate standardized procedures for data management and program effectiveness and costs, such as— (1) studying the costs and effectiveness of newborn screening, evaluation and intervention programs, and surveillance systems conducted by State-based programs in order to answer issues of importance to State and national policymakers; (2) studying the effectiveness of newborn screening followup and intervention programs by assessing the health and development of children at school age and as young adults; (3) promoting the sharing of data regarding newborn screening with State-based birth defects and developmental disabilities monitoring programs; (4) ensuring coordination of surveillance activities, including— (A) standardized data collection and reporting; and (B) use of electronic health records; (5) facilitating quality improvement in treatment and disease management based on gaps in services or care identified by longitudinal tracking systems; and (6) utilizing data from longitudinal tracking systems to support the development and evaluation of evidence-based guidelines for diagnosis, treatment, and disease management. (c) Eligible entity In this section, the term eligible entity means— (1) a State or a political subdivision of a State; (2) a consortium of 2 or more States or subdivisions described in paragraph (1); (3) a health facility or program operated by or pursuant to a contract with, or a grant from, the Indian Health Service; or (4) any other entity with appropriate expertise in newborn screening, as determined by the Secretary. . 11. Authorization of appropriations The Public Health Service Act is amended by inserting after section 1116A of such Act, as added by section 10 of this Act, the following: 1116B. 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, $13,334,000 for each of fiscal years 2014 through 2018; (2) to carry out section 1113, $7,500,000 for each of fiscal years 2014 through 2018; and (3) to carry out section 1116A, $5,000,000 for each of fiscal years 2014 through 2018. .

tv_txt: IB 113th CONGRESS 2d Session H. R. 1281 IN THE HOUSE OF REPRESENTATIVES AN ACT 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 ) is amended— (1) in subsection (a)— (A) in the matter preceding paragraph (1)— (i) by striking subsection (j) and inserting section 1117 ; and (ii) by striking and in consultation with the Advisory Committee and inserting 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 at the end; (D) in paragraph (4)— (i) by striking treatment and inserting followup and treatment ; and (ii) by striking the period and inserting ; and ; 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) and inserting application for a grant under this section ; (3) in subsection (h), by striking application submitted under subsection (c)(2) each place it appears and inserting application for a grant under this section ; and (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 ) is amended— (1) in the section heading, by inserting and followup after child screening ; (2) in subsection (a), by striking of screening, and inserting , including with respect to timeliness, of screening, followup, ; (3) in subsection (b)— (A) in paragraph (1)— (i) by striking counseling, testing and inserting treatment, counseling, testing, followup, ; and (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 and inserting treatment, counseling, testing, followup, ; (ii) by inserting in a timely manner after in newborns and children ; and (iii) by striking or at the end; (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 ) is amended— (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 after public health impact ; and (D) in paragraph (8) (as so redesignated)— (i) in subparagraph (A), by striking achieve rapid diagnosis and inserting 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 at the end; (iv) in subparagraph (K), by striking the period and inserting ; and ; 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 and inserting 120 ; and (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 ) is amended— (1) in subsection (a)— (A) in paragraph (2), by striking and at the end; (B) in paragraph (3)— (i) by striking data and inserting information ; and (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 and inserting Newborn Screening Saves Lives Reauthorization Act of 2014 ; (3) in subsection (c)— (A) by striking developing the clearinghouse and inserting carrying out activities ; and (B) by striking clearinghouse minimizes duplication and supplements, not supplants and inserting activities minimize duplication and supplement, not supplant ; and (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 ) is amended— (1) in the section heading, by inserting and surveillance before the period; (2) in subsection (a)— (A) in the matter preceding paragraph (1), by striking and in consultation with the Advisory Committee and inserting and taking into consideration the expertise of the Advisory Committee ; and (B) in paragraph (1), by inserting timeliness for processing such tests, after newborn-screening tests, ; and (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 ) is amended— (1) in subsection (c), by striking the Administrator, the Director of the Agency for Healthcare Research and Quality, and inserting 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, ; and (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) ) is amended— (1) by striking consortia and inserting consortium ; and (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 ) is amended— (1) in subsection (a)(1)— (A) in subparagraph (B), by striking ; and and inserting a semicolon; (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. ) is amended by adding at the end, the following: 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.

Passed the House of Representatives June 24, 2014. Karen L. Haas, Clerk.

tv_txt: IIB 113th CONGRESS 2d Session H. R. 1281 IN THE SENATE OF THE UNITED STATES June 25, 2014 Received AN ACT 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 ) is amended— (1) in subsection (a)— (A) in the matter preceding paragraph (1)— (i) by striking subsection (j) and inserting section 1117 ; and (ii) by striking and in consultation with the Advisory Committee and inserting 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 at the end; (D) in paragraph (4)— (i) by striking treatment and inserting followup and treatment ; and (ii) by striking the period and inserting ; and ; 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) and inserting application for a grant under this section ; (3) in subsection (h), by striking application submitted under subsection (c)(2) each place it appears and inserting application for a grant under this section ; and (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 ) is amended— (1) in the section heading, by inserting and followup after child screening ; (2) in subsection (a), by striking of screening, and inserting , including with respect to timeliness, of screening, followup, ; (3) in subsection (b)— (A) in paragraph (1)— (i) by striking counseling, testing and inserting treatment, counseling, testing, followup, ; and (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 and inserting treatment, counseling, testing, followup, ; (ii) by inserting in a timely manner after in newborns and children ; and (iii) by striking or at the end; (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 ) is amended— (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 after public health impact ; and (D) in paragraph (8) (as so redesignated)— (i) in subparagraph (A), by striking achieve rapid diagnosis and inserting 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 at the end; (iv) in subparagraph (K), by striking the period and inserting ; and ; 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 and inserting 120 ; and (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 ) is amended— (1) in subsection (a)— (A) in paragraph (2), by striking and at the end; (B) in paragraph (3)— (i) by striking data and inserting information ; and (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 and inserting Newborn Screening Saves Lives Reauthorization Act of 2014 ; (3) in subsection (c)— (A) by striking developing the clearinghouse and inserting carrying out activities ; and (B) by striking clearinghouse minimizes duplication and supplements, not supplants and inserting activities minimize duplication and supplement, not supplant ; and (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 ) is amended— (1) in the section heading, by inserting and surveillance before the period; (2) in subsection (a)— (A) in the matter preceding paragraph (1), by striking and in consultation with the Advisory Committee and inserting and taking into consideration the expertise of the Advisory Committee ; and (B) in paragraph (1), by inserting timeliness for processing such tests, after newborn-screening tests, ; and (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 ) is amended— (1) in subsection (c), by striking the Administrator, the Director of the Agency for Healthcare Research and Quality, and inserting 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, ; and (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) ) is amended— (1) by striking consortia and inserting consortium ; and (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 ) is amended— (1) in subsection (a)(1)— (A) in subparagraph (B), by striking ; and and inserting a semicolon; (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. ) is amended by adding at the end, the following: 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.

Passed the House of Representatives June 24, 2014. Karen L. Haas, Clerk

tv_txt: IB Union Calendar No. 354 113th CONGRESS 2d Session H. R. 1281 [Report No. 113–478] IN THE HOUSE OF REPRESENTATIVES March 20, 2013 Ms. Roybal-Allard (for herself and Mr. Simpson ) introduced the following bill; which was referred to the Committee on Energy and Commerce June 19, 2014 Additional sponsors: Ms. Moore , Mr. Grijalva , Mr. Waxman , Mr. Rogers of Kentucky , Mr. Higgins , Mr. Rangel , Ms. Lee of California , Ms. Speier , Mr. McGovern , Mrs. Capps , Ms. Jackson Lee , Mr. Hastings of Florida , Ms. McCollum , Mr. David Scott of Georgia , Ms. Clarke of New York , Mr. Conyers , Mr. Dingell , Mr. Huffman , Ms. DeLauro , Mr. Crowley , Mr. Cohen , Ms. Slaughter , Mr. Bishop of Georgia , Ms. Castor of Florida , Mr. Takano , Ms. Wilson of Florida , Mr. Loebsack , Mr. Bera of California , Mr. Walden , Mr. Nadler , Mr. Gene Green of Texas , Mr. Delaney , Mr. Collins of New York , Mr. Pocan , Mr. Heck of Washington , Mr. Farr , Mr. Matheson , Mrs. Beatty , Mrs. Kirkpatrick , Mr. Moran , Mr. Sires , Ms. Schakowsky , Mr. Costa , Ms. Loretta Sanchez of California , Mr. Ruiz , Mrs. Negrete McLeod , Mr. Castro of Texas , Mr. Gallego , Mr. Becerra , Mr. Sablan , Ms. Michelle Lujan Grisham of New Mexico , Mr. Cárdenas , Mr. Gutiérrez , Mr. Ryan of Ohio , Mr. Ben Ray Luján of New Mexico , Mr. Garcia , Mr. Hinojosa , Mrs. Napolitano , Mr. Vargas , Mr. Serrano , Ms. Velázquez , Mr. King of New York , Mrs. Capito , Mr. Calvert , Mr. Royce , Mr. Grayson , Ms. Esty , Mr. Gary G. Miller of California , Mr. Jones , Mr. McKeon , Mr. Pierluisi , Mr. Schiff , Mr. Neal , Mr. Langevin , Mr. Doyle , Mr. Tonko , Ms. Wasserman Schultz , Ms. DeGette , Ms. Eshoo , Mrs. Lowey , Mr. Barton , Mr. Danny K. Davis of Illinois , Mr. Garamendi , Mr. McDermott , Mr. Nunes , Mr. Courtney , Mr. Levin , Mr. Cicilline , Mr. Welch , Mr. Blumenauer , Ms. Titus , Mr. Lipinski , Mr. Tierney , Mr. Larson of Connecticut , Ms. Matsui , Ms. Granger , Mr. Latham , Mrs. Christensen , Mr. Lance , Mr. Ellison , Mr. Honda , Ms. Shea-Porter , Ms. Brownley of California , Ms. Edwards , Mr. Meeks , Mr. Michaud , Ms. Eddie Bernice Johnson of Texas , Mr. Payne , Mr. Pallone , Mr. Johnson of Georgia , Mr. Lowenthal , Mr. Thompson of California , Mr. Clay , Mr. Cartwright , Ms. Schwartz , Mr. Pascrell , Mr. Burgess , Mrs. McMorris Rodgers , and Mr. Israel 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 Strike out all after the enacting clause and insert the part printed in italic For text of introduced bill, see copy of bill as introduced on March 20, 2013 A BILL 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 ) is amended— (1) in subsection (a)— (A) in the matter preceding paragraph (1)— (i) by striking subsection (j) and inserting section 1117 ; and (ii) by striking and in consultation with the Advisory Committee and inserting 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 at the end; (D) in paragraph (4)— (i) by striking treatment and inserting followup and treatment ; and (ii) by striking the period and inserting ; and ; 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) and inserting application for a grant under this section ; (3) in subsection (h), by striking application submitted under subsection (c)(2) each place it appears and inserting application for a grant under this section ; and (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 ) is amended— (1) in the section heading, by inserting and followup after child screening ; (2) in subsection (a), by striking of screening, and inserting , including with respect to timeliness, of screening, followup, ; (3) in subsection (b)— (A) in paragraph (1)— (i) by striking counseling, testing and inserting treatment, counseling, testing, followup, ; and (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 and inserting treatment, counseling, testing, followup, ; (ii) by inserting in a timely manner after in newborns and children ; and (iii) by striking or at the end; (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 ) is amended— (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 after public health impact ; and (D) in paragraph (8) (as so redesignated)— (i) in subparagraph (A), by striking achieve rapid diagnosis and inserting 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 at the end; (iv) in subparagraph (K), by striking the period and inserting ; and ; 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 and inserting 120 ; and (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 ) is amended— (1) in subsection (a)— (A) in paragraph (2), by striking and at the end; (B) in paragraph (3)— (i) by striking data and inserting information ; and (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 and inserting Newborn Screening Saves Lives Reauthorization Act of 2014 ; (3) in subsection (c)— (A) by striking developing the clearinghouse and inserting carrying out activities ; and (B) by striking clearinghouse minimizes duplication and supplements, not supplants and inserting activities minimize duplication and supplement, not supplant ; and (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 ) is amended— (1) in the section heading, by inserting and surveillance before the period; (2) in subsection (a)— (A) in the matter preceding paragraph (1), by striking and in consultation with the Advisory Committee and inserting and taking into consideration the expertise of the Advisory Committee ; and (B) in paragraph (1), by inserting timeliness for processing such tests, after newborn-screening tests, ; and (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 ) is amended— (1) in subsection (c), by striking the Administrator, the Director of the Agency for Healthcare Research and Quality, and inserting 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, ; and (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) ) is amended— (1) by striking consortia and inserting consortium ; and (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 ) is amended— (1) in subsection (a)(1)— (A) in subparagraph (B), by striking ; and and inserting a semicolon; (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. ) is amended by adding at the end, the following: 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

tv_txt: 113th CONGRESS 2d Session H.R. 1281 In the Senate of the United States, December 8, 2014. Amendment:

That the bill from the House of Representatives (H.R. 1281) entitled An Act to amend the Public Health Service Act to reauthorize programs under part A of title XI of such Act. , do pass with the following At the end, add the following: 12. Informed consent for newborn screening research (a) In general Research on newborn dried blood spots shall be considered research carried out on human subjects meeting the definition of section 46.102(f)(2) of title 45, Code of Federal Regulations, for purposes of Federally funded research conducted pursuant to the Public Health Service Act until such time as updates to the Federal Policy for the Protection of Human Subjects (the Common Rule) are promulgated pursuant to subsection (c). For purposes of this subsection, sections 46.116(c) and 46.116(d) of title 45, Code of Federal Regulations, shall not apply. (b) Effective date Subsection (a) shall apply only to newborn dried blood spots used for purposes of Federally funded research that were collected not earlier than 90 days after the date of enactment of this Act. (c) Regulations Not later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate proposed regulations related to the updating of the Federal Policy for the Protection of Human Subjects (the Common Rule), particularly with respect to informed consent. Not later than 2 years after such date of enactment, the Secretary shall promulgate final regulations based on such proposed regulations.

Secretary

tv_txt: IB One Hundred Thirteenth Congress of the United States of America At the Second Session Begun and held at the City of Washington on Friday, the third day of January, two thousand and fourteen H. R. 1281 AN ACT 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. Sec. 12. Informed consent for newborn screening research. 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 ) is amended— (1) in subsection (a)— (A) in the matter preceding paragraph (1)— (i) by striking subsection (j) and inserting section 1117 ; and (ii) by striking and in consultation with the Advisory Committee and inserting 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 at the end; (D) in paragraph (4)— (i) by striking treatment and inserting followup and treatment ; and (ii) by striking the period and inserting ; and ; 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) and inserting application for a grant under this section ; (3) in subsection (h), by striking application submitted under subsection (c)(2) each place it appears and inserting application for a grant under this section ; and (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 ) is amended— (1) in the section heading, by inserting and followup after child screening ; (2) in subsection (a), by striking of screening, and inserting , including with respect to timeliness, of screening, followup, ; (3) in subsection (b)— (A) in paragraph (1)— (i) by striking counseling, testing and inserting treatment, counseling, testing, followup, ; and (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 and inserting treatment, counseling, testing, followup, ; (ii) by inserting in a timely manner after in newborns and children ; and (iii) by striking or at the end; (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 ) is amended— (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 after public health impact ; and (D) in paragraph (8) (as so redesignated)— (i) in subparagraph (A), by striking achieve rapid diagnosis and inserting 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 at the end; (iv) in subparagraph (K), by striking the period and inserting ; and ; 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 and inserting 120 ; and (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 ) is amended— (1) in subsection (a)— (A) in paragraph (2), by striking and at the end; (B) in paragraph (3)— (i) by striking data and inserting information ; and (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 and inserting Newborn Screening Saves Lives Reauthorization Act of 2014 ; (3) in subsection (c)— (A) by striking developing the clearinghouse and inserting carrying out activities ; and (B) by striking clearinghouse minimizes duplication and supplements, not supplants and inserting activities minimize duplication and supplement, not supplant ; and (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 ) is amended— (1) in the section heading, by inserting and surveillance before the period; (2) in subsection (a)— (A) in the matter preceding paragraph (1), by striking and in consultation with the Advisory Committee and inserting and taking into consideration the expertise of the Advisory Committee ; and (B) in paragraph (1), by inserting timeliness for processing such tests, after newborn-screening tests, ; and (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 ) is amended— (1) in subsection (c), by striking the Administrator, the Director of the Agency for Healthcare Research and Quality, and inserting 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, ; and (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) ) is amended— (1) by striking consortia and inserting consortium ; and (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 ) is amended— (1) in subsection (a)(1)— (A) in subparagraph (B), by striking ; and and inserting a semicolon; (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. ) is amended by adding at the end, the following: 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. 12. Informed consent for newborn screening research (a) In general Research on newborn dried blood spots shall be considered research carried out on human subjects meeting the definition of section 46.102(f)(2) of title 45, Code of Federal Regulations, for purposes of Federally funded research conducted pursuant to the Public Health Service Act until such time as updates to the Federal Policy for the Protection of Human Subjects (the Common Rule) are promulgated pursuant to subsection (c). For purposes of this subsection, sections 46.116(c) and 46.116(d) of title 45, Code of Federal Regulations, shall not apply. (b) Effective date Subsection (a) shall apply only to newborn dried blood spots used for purposes of Federally funded research that were collected not earlier than 90 days after the date of enactment of this Act. (c) Regulations Not later than 6 months after the date of enactment of this Act, the Secretary of Health and Human Services shall promulgate proposed regulations related to the updating of the Federal Policy for the Protection of Human Subjects (the Common Rule), particularly with respect to informed consent. Not later than 2 years after such date of enactment, the Secretary shall promulgate final regulations based on such proposed regulations.

Speaker of the House of Representatives. Vice President of the United States and President of the Senate.