Title: Newborn Screening Saves Lives Reauthorization Act of 2021
Policy area: Health

Summary:
Newborn Screening Saves Lives Reauthorization Act of 2021
This bill reauthorizes through FY2026 and revises several programs and activities relating to newborn screening for certain conditions and genetic, endocrine, and metabolic diseases.
Among its changes, the bill reauthorizes and makes mandatory
The bill also aligns statutory requirements for research on non-identified newborn blood spots with federal regulations governing research on human subjects. These blood spots are collected as part of newborn screening programs, and some states make them available for biomedical and public health research. Under current regulations, research on non-identified bio-specimens such as blood spots is not considered to be research on human subjects, to which additional protections apply.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 482 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 482

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

                            January 25, 2021

       Ms. Roybal-Allard (for herself, Mr. Simpson, Ms. Clark of 
 Massachusetts, Ms. Herrera Beutler, Ms. Clarke of New York, Mr. Danny 
   K. Davis of Illinois, Mr. Fitzpatrick, Mr. Sires, Mr. Raskin, Ms. 
DeGette, Mr. Higgins of New York, Mr. Stewart, Mr. Calvert, Mrs. Axne, 
  Mr. Stivers, Ms. Williams of Georgia, Mr. Butterfield, Mr. Smith of 
Washington, Mr. Casten, Mr. Cohen, Ms. Castor of Florida, Mr. Hastings, 
Mr. Gallego, Mr. Khanna, and Mr. Neguse) 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 2021''.

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

    (a) Purposes.--Section 1109(a) of the Public Health Service Act (42 
U.S.C. 300b-8(a)) is amended--
            (1) in paragraph (1), by striking ``enhance, improve or'' 
        and inserting ``facilitate, enhance, improve, or'';
            (2) by amending paragraph (3) to read as follows:
            ``(3) to develop, and deliver to parents, families, and 
        patient advocacy and support groups, educational programs 
        that--
                    ``(A) address newborn screening counseling, testing 
                (including newborn screening pilot studies), follow-up, 
                treatment, specialty services, and long-term care;
                    ``(B) assess the target audience's current 
                knowledge, incorporate health communications 
                strategies, and measure impact; and
                    ``(C) are at appropriate literacy levels;''; and
            (3) in paragraph (4)--
                    (A) by striking ``followup'' and inserting 
                ``follow-up''; and
                    (B) by inserting before the semicolon at the end 
                the following: ``, including re-engaging patients who 
                have not received recommended follow-up services and 
                supports''.
    (b) Approval Factors.--Section 1109(c) of the Public Health Service 
Act (42 U.S.C. 300b-8(c)) is amended--
            (1) by striking ``or will use'' and inserting ``will use''; 
        and
            (2) by inserting ``, or will use amounts received under 
        such grant to enhance capacity and infrastructure to facilitate 
        the adoption of,'' before ``the guidelines and 
        recommendations''.

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 (5), by inserting ``and adopt 
                process improvements'' after ``take appropriate 
                steps'';
                    (B) in paragraph (7) by striking ``and'' at the 
                end;
                    (C) by redesignating paragraph (8) as paragraph 
                (9);
                    (D) 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'';
                    (E) in paragraph (9), as redesignated--
                            (i) by redesignating subparagraphs (K) and 
                        (L) as subparagraphs (L) and (M), respectively; 
                        and
                            (ii) by inserting after subparagraph (J) 
                        the following:
                    ``(K) the appropriate and recommended use of safe 
                and effective genetic testing by health care 
                professionals in newborns and children with an initial 
                diagnosis of a disease or condition characterized by a 
                variety of genetic causes and manifestations;''; and
            (2) in subsection (g)--
                    (A) in paragraph (1) by striking ``2019'' and 
                inserting ``2026''; and
                    (B) in paragraph (2) by striking ``2019'' and 
                inserting ``2026''.

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 piloted 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 shall ensure that entities 
receiving funding through the program will provide assurances, as 
practicable, that such entities will work in consultation with State 
departments of health, as appropriate.''.

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 ``2022''; 
                and
                    (C) by striking ``2019'' and inserting ``2026''; 
                and
            (2) in paragraph (2)--
                    (A) by striking ``$8,000,000'' and inserting 
                ``$29,650,000'';
                    (B) by striking ``2015'' and inserting ``2022''; 
                and
                    (C) by striking ``2019'' and inserting ``2026''.

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 section 
46.104(d)(4) of title 45, Code of Federal Regulations (or successor 
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.
            (8) The impact on newborn morbidity and mortality in States 
        that adopt newborn screening tests included on the uniform 
        panel.
    (b) Public Stakeholder Meeting.--In the course of completing the 
study described in subsection (a), NAM or such other appropriate entity 
shall hold not less than one public meeting to obtain stakeholder input 
on the topics of such study.
    (c) 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.
    (d) Authorization of Appropriations.--There is authorized to be 
appropriated $2,000,000 for the period of fiscal years 2022 and 2023 to 
carry out this section.
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