Title: The Newborn Screening Saves Lives Reauthorization Act of 2019
Policy area: Health

Summary:
The Newborn Screening Saves Lives Reauthorization Act of 2019  This bill expands and reauthorizes through FY2024 various programs related to the screening of newborns for heritable diseases, including (1) grants to local public health agencies, (2) the Advisory Committee on Heritable Disorders in Newborns and Children, (3) assessments of the effectiveness of such screenings, and (4) research into new screening technologies.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 2158 Introduced in Senate (IS)]

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116th CONGRESS
  1st Session
                                S. 2158

   To improve certain programs of the Department of Health and Human 
             Services with respect to heritable disorders.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 18, 2019

Ms. Hassan (for herself and Mr. Gardner) introduced the following bill; 
     which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To improve certain programs of the Department of Health and Human 
             Services with respect to heritable disorders.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``The Newborn Screening Saves Lives 
Reauthorization Act of 2019''.

SEC. 2. AMENDMENTS.

    (a) Improved Newborn and Child Screening for Heritable Disorders.--
Section 1109(a)(3) of the Public Health Service Act (42 U.S.C. 300b-
8(a)(3)) is amended--
            (1) by striking ``develop and deliver educational programs 
        (at appropriate literacy levels)'' and inserting ``develop, 
        deliver, and assess the impact of educational programs (with 
        varying levels of information and at appropriate literacy 
        levels)''; and
            (2) by striking ``and specialty services'' and inserting 
        ``specialty services, research-related pilot studies, and long-
        term care''.
    (b) Extension of Advisory Committee on Heritable Disorders in 
Newborns and Children.--Section 1111(g) of the Public Health Service 
Act (42 U.S.C. 300b-10(g)) is amended by striking ``2019'' each place 
it appears and inserting ``2024''.
    (c) Technical Amendments.--Title XI of the Public Health Service 
Act (42 U.S.C. 300b-1 et seq.) is amended--
            (1) in the section heading of section 1110, by striking 
        ``followup'' and inserting ``follow-up'';
            (2) in sections 1109, 1110, and 1111, by striking 
        ``followup'' each place such term appears and inserting 
        ``follow-up''; and
            (3) in paragraphs (1) and (2) of section 1110(b), by 
        inserting ``(including long-term follow-up)'' before ``, or 
        specialty''.
    (d) Clearinghouse of Newborn Screening Information.--Subsection (c) 
of section 1112 of the Public Health Service Act (42 U.S.C. 300b-11) is 
amended to read as follows:
    ``(c) Nonduplication.--In carrying out activities under this 
section, the Secretary shall ensure that such activities minimize 
duplication and complement other existing Federal newborn screening-
related information-sharing activities.''.
    (e) Laboratory Quality and Surveillance.--Section 1113 of the 
Public Health Service Act (42 U.S.C. 300b-12) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                            (i) by striking ``performance evaluation 
                        services'' and inserting ``development of new 
                        screening tests''; and
                            (ii) by striking ``; and'' and inserting a 
                        semicolon;
                    (B) in paragraph (2)--
                            (i) by striking ``performance test 
                        materials'' and inserting ``test performance 
                        materials''; and
                            (ii) by striking the period and inserting 
                        ``; and''; and
                    (C) by adding at the end the following:
            ``(3) performance evaluation services to enhance disease 
        detection, including the development of tools and resources to 
        improve data analysis, interpretation of test results, and 
        dissemination of laboratory best practices.''; and
            (2) in subsection (b)--
                    (A) in paragraph (1), by striking ``; and'' and 
                inserting a semicolon;
                    (B) in paragraph (2), by striking the period and 
                inserting ``; and''; and
                    (C) by adding at the end, the following:
            ``(3) by assisting States, as appropriate, in assessing and 
        conducting long-term follow-up and assessing long-term 
        outcomes.''.
    (f) Hunter Kelly Research Program.--Section 1116(a)(1)(D) of the 
Public Health Service Act (42 U.S.C. 300b-15(a)(1)(D)) is amended--
            (1) by inserting ``, or with a high probability of being 
        recommend by,'' after ``recommended by''; and
            (2) by striking ``to ensure that screenings are ready for 
        nationwide implementation'' and inserting ``, which may include 
        those conditions that have been nominated pursuant to section 
        1111, to ensure that screening technologies are piloted and 
        ready for implementation''.
    (g) Authorization of Appropriations.--Section 1117 of the Public 
Health Service Act (42 U.S.C. 300b-16) is amended--
            (1) in paragraph (1), by striking ``$11,900,000 for each of 
        fiscal years 2015 through 2019'' and inserting ``$16,383,000 
        for each of fiscal years 2020 through 2024''; and
            (2) in paragraph (2), by striking ``$8,000,000 for each of 
        fiscal years 2015 through 2019'' and inserting ``$17,250,000 
        for each of fiscal years 2020 through 2024''.
    (h) Technical Assistance.--The Secretary shall publish on the 
internet website of the Department of Health and Human Services, 
information regarding the process for obtaining technical assistance 
for submitting nominations to the recommended uniform screening panel.
    (i) Report on the Modernization of Newborn Screening.--
            (1) In general.--The Secretary of Health and Human Services 
        shall, directly or through a contract, conduct an assessment of 
        each of the following:
                    (A) The uniform screening panel review and 
                recommendation processes, including an assessment of 
                factors that impact decisions to add new conditions to 
                the uniform screening panel and challenges associated 
                with newly nominated conditions, including rare 
                diseases with late onset variants.
                    (B) Strategies to support implementation of uniform 
                screening panel recommendations.
                    (C) Opportunities to improve newborn screening 
                research, such as piloting the screening of multiple 
                conditions in a single test and optimizing the capacity 
                for such research.
                    (D) Technologies that would improve screening, 
                including technologies that identify multiple, related 
                disorders in a single test.
                    (E) Methods to improve public health surveillance, 
                timeliness of diagnosis, and short- and long-term 
                follow-up for infants identified through newborn 
                screening.
                    (F) Strategies to improve communication with the 
                public and stakeholders in order to promote 
                understanding and knowledge of the newborn screening 
                system.
                    (G) The quality of data on disease prevalence for 
                screened conditions.
                    (H) The effect of newborn screening on the outcomes 
                of those identified as newborns through such 
                screenings.
            (2) Report.--Not later than 2 years after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall 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 
        containing the results of the assessment and recommendations to 
        improve processes described in paragraph (1).
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