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

Summary:
Newborn Screening Saves Lives Reauthorization Act of 2019
This bill reauthorizes through FY2024 and revises several programs and activities relating to newborn screening for genetic diseases. Among other things, the bill reauthorizes, and makes mandatory rather than discretionary, the Hunter Kelly Research Program at the National Institutes of Health as well as national surveillance activities conducted by the Centers for Disease Control and Prevention.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2507 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 2507

To amend the Public Health Service Act to reauthorize certain programs 
under part A of title XI of such Act relating to genetic diseases, and 
                          for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 2, 2019

       Ms. Roybal-Allard (for herself, Mr. Simpson, Ms. Clark of 
Massachusetts, and Ms. Herrera Beutler) 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 certain programs 
under part A of title XI of such Act relating to genetic diseases, and 
                          for other purposes.

    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 ``Newborn Screening Saves Lives 
Reauthorization Act of 2019''.

SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND FOLLOW-UP FOR 
              HERITABLE DISORDERS.

    Section 1109(a)(3) of the Public Health Service Act (42 U.S.C. 
300b-8(a)(3)) is amended to read as follows:
            ``(3) to develop and deliver educational programs (at 
        appropriate literacy levels) about newborn screening 
        counseling, testing, follow-up, treatment, specialty services, 
        and long-term care to parents, families, and patient advocacy 
        and support groups that assess the target audience's current 
        knowledge, incorporate health communications strategies, and 
        measure impact;''.

SEC. 3. 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 (7) by striking ``and'' at the 
                end;
                    (B) by redesignating paragraph (8) as paragraph 
                (9); and
                    (C) by inserting after paragraph (7) the following:
            ``(8) develop, maintain, and publish on a publicly 
        accessible website consumer-friendly materials detailing--
                    ``(A) the uniform screening panel nomination 
                process, including data requirements, standards, and 
                the use of international data in nomination 
                submissions; and
                    ``(B) the process for obtaining technical 
                assistance for submitting nominations to the uniform 
                screening panel and detailing the instances in which 
                the provision of technical assistance would introduce a 
                conflict of interest for members of the Advisory 
                Committee; and''; and
            (2) in subsection (g)--
                    (A) in paragraph (1) by striking ``2019'' and 
                inserting ``2024''; and
                    (B) in paragraph (2) by striking ``2019'' and 
                inserting ``2024''.

SEC. 4. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.

    Section 1112(c) of the Public Health Service Act (42 U.S.C. 300b-
11(c)) is amended by striking ``and supplement, not supplant, existing 
information sharing efforts'' and inserting ``and complement other 
Federal newborn screening information sharing activities''.

SEC. 5. 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'' at the end;
                    (B) in paragraph (2)--
                            (i) by striking ``performance test 
                        materials'' and inserting ``test performance 
                        materials''; and
                            (ii) by striking the period at the end 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, resources, and 
        infrastructure to improve data analysis, test result 
        interpretation, data harmonization, and dissemination of 
        laboratory best practices.''; and
            (2) in subsection (b) to read as follows:
    ``(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, 
shall provide for the coordination of national surveillance activities, 
including--
            ``(1) standardizing data collection and reporting through 
        the use of electronic and other forms of health records to 
        achieve real-time data for tracking and monitoring the newborn 
        screening system, from the initial positive screen through 
        diagnosis and long-term care management; and
            ``(2) by promoting data sharing linkages between State 
        newborn screening programs and State-based birth defects and 
        developmental disabilities surveillance programs to help 
        families connect with services to assist in evaluating long-
        term outcomes.''.

SEC. 6. 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) by striking ``may'' and inserting ``shall''; 
                and
                    (B) in subparagraph (D)--
                            (i) by inserting ``, or with a high 
                        probability of being recommended by,'' after 
                        ``recommended by''; and
                            (ii) by striking ``that screenings are 
                        ready for nationwide implementation'' and 
                        inserting ``that reliable newborn screening 
                        technologies are evaluated and ready for use''; 
                        and
            (2) in subsection (b) to read as follows:
    ``(b) Funding.--In carrying out the research program under this 
section, the Secretary and the Director--
            ``(1) shall ensure that entities receiving funding through 
        the program will provide assurances, as practicable, that such 
        entities will work in consultation with the appropriate State 
        departments of health; and
            ``(2) may accept, use, and dispose of donations and 
        bequests from private for-profit and non-profit entities, in 
        accordance with Federal law.''.

SEC. 7. AUTHORIZATION OF APPROPRIATIONS FOR NEWBORN SCREENING PROGRAMS 
              AND ACTIVITIES.

    Section 1117 of the Public Health Service Act (42 U.S.C. 300b-16) 
is amended--
            (1) in paragraph (1)--
                    (A) by striking ``$11,900,000'' and inserting 
                ``$31,000,000'';
                    (B) by striking ``2015'' and inserting ``2020''; 
                and
                    (C) by striking ``2019'' and inserting ``2024''; 
                and
            (2) in paragraph (2)--
                    (A) by striking ``$8,000,000'' and inserting 
                ``$29,650,000'';
                    (B) by striking ``2015'' and inserting ``2020''; 
                and
                    (C) by striking ``2019'' and inserting ``2024''.

SEC. 8. INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM.

    Section 12 of the Newborn Screening Saves Lives Reauthorization Act 
of 2014 (42 U.S.C. 289 note) is amended to read as follows:

``SEC. 12. INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM.

    ``Research on nonidentified newborn dried blood spots shall be 
considered secondary research (as that term is defined in part 4 of 
section 46.104 of title 45, Code of Federal Regulations) with 
nonidentified biospecimens for purposes of federally funded research 
conducted pursuant to the Public Health Service Act (42 U.S.C. 200 et 
seq.).''.

SEC. 9. NAM REPORT ON THE MODERNIZATION OF NEWBORN SCREENING.

    (a) Study.--Not later than 60 days after the date of the enactment 
of this Act, the Secretary of Health and Human Services shall seek to 
enter into an agreement with the National Academy of Medicine (in this 
section referred to as ``NAM'') (or if NAM declines to enter into such 
an agreement, another appropriate entity) under which NAM, or such 
other appropriate entity, agrees to conduct a study on the following:
            (1) The uniform screening panel review and recommendation 
        processes to identify factors that impact decisions to add new 
        conditions to the uniform screening panel, to describe 
        challenges posed by newly nominated conditions, including low-
        incidence diseases, late onset variants, and new treatments 
        without long-term efficacy data.
            (2) The barriers that preclude States from adding new 
        uniform screening panel conditions to their State screening 
        panels with recommendations on resources needed to help States 
        implement uniform screening panel recommendations.
            (3) The current state of federally and privately funded 
        newborn screening research with recommendations for optimizing 
        the capacity of this research, including piloting multiple 
        prospective conditions at once and addressing rare disease 
        questions.
            (4) New and emerging technologies that would permit 
        screening for new categories of disorders, or would make 
        current screening more effective, more efficient, or less 
        expensive.
            (5) Technological and other infrastructure needs to improve 
        timeliness of diagnosis and short- and long-term follow-up for 
        infants identified through newborn screening and improve public 
        health surveillance.
            (6) Current and future communication and educational needs 
        for priority stakeholders and the public to promote 
        understanding and knowledge of a modernized newborn screening 
        system with an emphasis on evolving communication channels and 
        messaging.
            (7) The extent to which newborn screening yields better 
        data on the disease prevalence for screened conditions and 
        improves long-term outcomes for those identified through 
        newborn screening, including existing systems supporting such 
        data collection and recommendations for systems that would 
        allow for improved data collection.
    (b) Report.--Not later than 18 months after the effective date of 
the agreement under subsection (a), such agreement shall require NAM, 
or such other appropriate entity, to submit to the Secretary of Health 
and Human Services and the appropriate committees of jurisdiction of 
Congress a report containing--
            (1) the results of the study conducted under subsection 
        (a);
            (2) recommendations to modernize the processes described in 
        subsection (a)(1); and
            (3) recommendations for such legislative and administrative 
        action as NAM, or such other appropriate entity, determines 
        appropriate.
    (c) Authorization of Appropriations.--There is authorized to be 
appropriated $2,000,000 for the period of fiscal years 2020 and 2021 to 
carry out this section.
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