[House Report 116-174]
[From the U.S. Government Publishing Office]


116th Congress    }                                   {        Report
                        HOUSE OF REPRESENTATIVES
 1st Session      }                                   {       116-174

======================================================================



 
       NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2019

                                _______
                                

 July 23, 2019.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

 Mr. Pallone, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 2507]

    The Committee on Energy and Commerce, to whom was referred 
the bill (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, 
having considered the same, report favorably thereon with an 
amendment and recommend that the bill as amended do pass.

                                CONTENTS

                                                                   Page
  I. Purpose and Summary..............................................4
 II. Background and Need for the Legislation..........................5
III. Committee Hearings...............................................6
 IV. Committee Consideration..........................................6
  V. Committee Votes..................................................6
 VI. Oversight Findings...............................................7
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures7
VIII.Federal Mandates Statement.......................................7

 IX. Statement of General Performance Goals and Objectives............7
  X. Duplication of Federal Programs..................................7
 XI. Committee Cost Estimate..........................................7
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits......8
XIII.Advisory Committee Statement.....................................8

XIV. Applicability to Legislative Branch..............................8
 XV. Section-by-Section Analysis of the Legislation...................8
XVI. Changes in Existing Law Made by the Bill, as Reported...........10

    The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

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.

  (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 ``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.
          (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 2020 and 2021 to 
carry out this section.

                         I. Purpose and Summary

    H.R. 2507, the ``Newborn Screening Saves Lives 
Reauthorization Act of 2019'', was introduced on May 2, 2019, 
by Reps. Roybal-Allard (D-CA), Simpson (R-ID), Clark (D-MA), 
and Herrera Beutler (R-WA) and referred to the Committee on 
Energy and Commerce. H.R. 2507 would reauthorize newborn 
screening programs at the U.S. Department of Health and Human 
Services for five years. The bill includes reforms to ensure 
that the activities of the Advisory Committee on Heritable 
Disorders in Newborns and Children (ACHDNC) at the Health 
Resources and Services Administration (HRSA) are transparent, 
including requiring the creation of a publicly accessible 
website that details the uniform screening panel nomination 
process. The bill also requires the Centers for Disease Control 
and Prevention (CDC) to standardize data collection and 
reporting to track and monitor newborn screening in real time. 
Additionally, the bill orders a study on the modernization of 
newborn screening. The bill authorizes appropriations of $60.65 
million per fiscal year from 2020 through 2024.

                II. Background and Need for Legislation

    Every year, more than 12,000 newborns are born with 
conditions that require early detection and treatment.\1\ 
Newborn screening provides for early identification of certain 
genetic, metabolic, hormonal, and functional conditions that 
may be treatable, but not apparent at birth. With proper 
screening, parents can receive education and children can 
receive appropriate follow-up treatment. As medical and 
scientific knowledge have advanced since the first newborn 
screening test was developed in the early 1960s, dozens more 
tests and treatments became available. However, a patchwork of 
state requirements for screening led to some newborns being 
screened for many disorders, and others very few.\2\ In 2004, 
the American College of Medical Genetics recommended that every 
baby born in the United States be screened for a core set of 29 
treatable disorders.\3\ At that time, only 21 states screened 
for at least nine of the recommended conditions.\4\ By 2008, 
significant improvements were made, but still, only 15 states 
and the District of Columbia required that infants be screened 
for all 29 recommended disorders.\5\
---------------------------------------------------------------------------
    \1\Government Accountability Office, GAO-17-196, Newborn Screening 
Timeliness (Dec. 15, 2016).
    \2\Examining Public Health Legislation to Help Local Communities: 
Hearing on H.R. 1281 Before the Subcommittee on Health, Committee on 
Energy & Commerce, 113th Cong. (Nov. 20, 2013) (statement of Edward 
R.B. McCabe, Chief Medical Officer, March of Dimes Foundation).
    \3\Id.
    \4\S. Rept. No. 110-280, at 2.
    \5\Id.
---------------------------------------------------------------------------
    While newborn screening remains a state public health 
activity, Congress passed the Newborn Screening Saves Lives Act 
in 2008, to better standardize and improve state universal 
newborn screening programs.\6\ The law codified the Recommended 
Universal Screening Panel (RUSP), which the ACHDNC at HRSA uses 
to make recommendations for conditions for which all newborns 
should be screened. To be considered as a core condition 
recommended for the RUSP, the condition must: (1) be able to be 
identified at a stage prior to when it would otherwise be 
apparent clinically (i.e., the screening must be necessary to 
identify the condition); (2) have a test with appropriate 
sensitivity and specificity available; and (3) have 
demonstrated benefits of early detection, timely intervention, 
and efficacious treatment of the condition.\7\ The law also 
authorized HRSA to develop a model decision-matrix for newborn 
screening expansion, and consider ways to ensure that all 
states attain the capacity to screen for the recommended 
conditions. The law also authorized research at the National 
Institutes of Health (NIH) to carry out research on newborn 
screening. Congress last reauthorized the law in 2014.
---------------------------------------------------------------------------
    \6\Pub. L. No. 110-204.
    \7\National Conference of State Legislatures, State Newborn Health 
Screening Policies, 25 LegisBrief 14 (Apr. 2017).
---------------------------------------------------------------------------
    Today, the RUSP includes 35 core conditions.\8\ While all 
states have caught up to testing for the original 29 
recommended conditions,\9\ and some have exceeded the current 
35 recommended core conditions, others have lagged behind as 
more tests have been added.\10\ The funding authorized in this 
legislation is intended to help break down those barriers 
preventing some states from adopting all 35 conditions, 
ensuring that children across the country are screened for all 
core conditions included on the RUSP.
---------------------------------------------------------------------------
    \8\Health Resources and Services Administration, Recommended 
Uniform Screening Panel (Feb. 2019) (www.hrsa.gov/advisory-committees/
heritable-disorders/rusp/index.html).
    \9\Scott M. Shone, Newborn Screening Policy Decisions, 80 N.C. Med. 
J. 1, 43 (Jan. 2019).
    \10\See note 7.
---------------------------------------------------------------------------

                        III. Committee Hearings

    For the purposes of section 103(i) of H. Res. 6 of the 
116th Congress the following hearing was used to develop or 
consider H.R. 2507:
    The Subcommittee on Health held a legislative hearing on 
June 25, 2019 on H.R. 2507, ``Newborn Screening Saves Lives 
Reauthorization Act of 2019'' and three other bills. The 
hearing was entitled ``Reauthorizing Vital Health Programs for 
American Families.'' The Subcommittee received testimony from:
           Amy Hewitt, Ph.D., Director, Institute on 
        Community Integration, University of Minnesota;
           Joseph Bocchini, M.D., Professor, Department 
        of Pediatrics Louisiana State University Health, 
        Shreveport;
           Patricia Kunz Howard, Ph.D., RN, President, 
        Emergency Nurses Association, Director, Emergency 
        Services, University of Kentucky Healthcare; and
           Jill Kagan, Director, ARCH National Respite 
        Network and Resource Center.

                      IV. Committee Consideration

    H.R. 2507, the ``Newborn Screening Saves Lives 
Reauthorization Act of 2019'' was introduced in the House on 
May 2, 2019, by Reps. Roybal-Allard, Simpson, Clark, and 
Herrera Beutler, and referred to the Committee on Energy and 
Commerce. Subsequently, the bill was referred to the 
Subcommittee on Health on May 3, 2019. Following a legislative 
hearing, the Subcommittee met in open markup session, pursuant 
to notice, on July 11, 2019, for consideration of the bill H.R. 
2507. During consideration of the bill, an amendment offered by 
Ms. Kelly (D-IL) was agreed to by a voice vote. Subsequently, 
the Subcommittee on Health agreed to a motion by Ms. Eshoo, 
Chairwoman of the Subcommittee, that H.R. 2507 be forwarded 
favorably to the full Committee on Energy and Commerce, 
amended, by a voice vote.
    On July 17, 2019, the full Committee met in open markup 
session, pursuant to notice, to consider the bill H.R. 2507, as 
amended by the Subcommittee. At the conclusion of consideration 
of the bill, the full Committee on Energy and Commerce agreed 
to a motion by Mr. Pallone, Chairman of the Committee, that 
H.R. 2507 be ordered reported favorably to the House, as 
amended, by a voice vote, a quorum being present.

                           V. Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list each record vote 
on the motion to report legislation and amendments thereto. The 
Committee advises that there were no record votes taken on H.R. 
2507.

                         VI. Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1) 
of rule X of the Rules of the House of Representatives, the 
Committee's oversight findings and recommendations are 
reflected in the descriptive portion of the report.

 VII. New Budget Authority, Entitlement Authority, and Tax Expenditures

    Pursuant to 3(c)(2) of rule XIII of the Rules of the House 
of Representatives, the Committee adopts as its own the 
estimate of new budget authority, entitlement authority, or tax 
expenditures or revenues contained in the cost estimate 
prepared by the Director of the Congressional Budget Office 
pursuant to section 402 of the Congressional Budget Act of 
1974.
    The Committee has requested but not received from the 
Director of the Congressional Budget Office a statement as to 
whether this bill contains any new budget authority, spending 
authority, credit authority, or an increase or decrease in 
revenues or tax expenditures.

                    VIII. Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

       IX. Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to 
reauthorize funding for the programs of the Newborn Screen 
Saves Lives Act, provide for transparency at ACHDNC, and 
authorize reforms to modernize and standardize newborn 
screening programs.

                   X. Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 2507 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

                      XI. Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974.

    XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 2507 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                   XIII. Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                XIV. Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

           XV. Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 designates that the short title may be cited as 
the ``Newborn Screening Saves Lives Reauthorization Act of 
2019''.

Section 2. Improved newborn and child screening and follow-up for 
        heritable disorders

    Section 2 amends the authorization terms for the grant 
program established under section 1109 of the Public Health 
Service Act to ensure that educational programs address newborn 
screening pilot studies and assess the target audience's 
current knowledge, incorporate health communication strategies, 
and measure the impact of these programs. This Section also 
authorizes grantees to establish, maintain, and operate a 
system to address and coordinate follow-up, ``including re-
engaging patients who have not received recommended follow-up 
services and supports.''

Section 3. Advisory Committee on Heritable Disorders in Newborns and 
        Children

    Section 3 amends the duties of ACHDNC to include the 
adoption of process improvements and requires the creation of a 
publicly accessible website which details the uniform screening 
panel nomination process, the process for obtaining technical 
assistance for submitting nominations for the uniform screening 
panel, and the instances in which the provision of technical 
assistance would introduce a conflict of interest for members 
of the Advisory Committee. The Committee does not intend for 
this section to necessarily preclude the NIH from providing 
agency expertise to the ACHDNC.

Section 4. Clearing house of newborn screening information

    Section 4 clarifies that the Secretary ensure that newborn 
screening activities under this program complement other 
Federal newborn screening information sharing activities.

Section 5. Laboratory quality and surveillance

    Section 5 amends laboratory quality and surveillance 
authorization language to instruct the Secretary, acting 
through the Director of the CDC and taking into consideration 
the expertise of ACHDNC to provide for quality assurance for 
laboratories involved in screening newborns and children for 
heritable disorders, including developing new screening tests. 
This section also instructs the Secretary to provide for 
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.'' The Secretary, acting through CDC, 
is also instructed to provide for the coordination of national 
surveillance activities, including standardizing data 
collection and reporting through the use of electronic and 
other health records to monitor the newborn screening system in 
real time, and by promoting data sharing between state newborn 
screening programs and developmental disabilities surveillance 
programs.

Section 6. Hunter Kelly research program

    Section 6 amends the authorizing language for the Hunter 
Kelly Newborn Screening Program at NIH by authorizing the 
Secretary, in conjunction with the NIH Director, to conduct 
pilot studies on conditions recommended by, or with a high 
probability of being recommended by the ACHDNC to ensure that 
reliable newborn screening technologies are evaluated and ready 
for use. This section also directs the Secretary and NIH 
Director to ensure that entities receiving funding through the 
program will provide reassurances that entities will work in 
consultation with State departments of health, as appropriate, 
and clarifies that the Secretary and Director may accept, use, 
and dispose of donations and bequest from private for-profit 
and non-profit entities, in accordance with Federal law.

Section 7. Authorization of appropriations for newborn screening 
        programs and activities

    Section 7 extends authorization of appropriations for 
newborn screening programs and activities.
    Paragraph (1) authorizes $31,000,000 to carry out sections 
1109, 1110, 1111, and 1112 for fiscal years 2020 through 2024.
    Paragraph (2) authorizes $29,650,000 to carry out section 
1113 for fiscal years 2020 through 2024.

Section 8. Institutional review boards; ethics guidance program

    Section 8 clarifies that research on nonidentified newborn 
dried blood spots be considered ``secondary research'' as 
defined by part 4 of subsection d of section 46.104 of title 45 
of the Code of Federal Regulations, also known as the Common 
Rule, which governs human research and privacy.

Section 9. NAM report on the modernization of newborn screening

    Section 9 directs the Secretary to enter into an agreement 
with the National Academy of Medicine to conduct a study on 
certain newborn screening activities and issue a report to 
Congress with recommendations to modernize the newborn 
screening processes. This section authorizes $2,000,000 in 
fiscal years 2020 and 2021 for the report.

       XVI. Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, and existing law in which no 
change is proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT




           *       *       *       *       *       *       *
  TITLE XI--GENETIC DISEASES, HEMOPHILIA PROGRAMS, AND SUDDEN INFANT 
                             DEATH SYNDROME


Part A--Genetic Diseases

           *       *       *       *       *       *       *



SEC. 1109. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE 
                    DISORDERS.

  (a) Authorization of Grant Program.--From amounts 
appropriated under section 1117, the Secretary, acting through 
the Administrator of the Health Resources and Services 
Administration (referred to in this section as the 
``Administrator'') and taking into consideration the expertise 
of the Advisory Committee on Heritable Disorders in Newborns 
and Children (referred to in this section as the ``Advisory 
Committee''), shall award grants to eligible entities to enable 
such entities--
          (1) to [enhance, improve or] facilitate, enhance, 
        improve, or expand the ability of State and local 
        public health agencies to provide screening, 
        counseling, or health care services to newborns and 
        children having or at risk for heritable disorders;
          (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;
          [(3) to develop and deliver educational programs (at 
        appropriate literacy levels) about newborn screening 
        counseling, testing, follow-up, treatment, and 
        specialty services to parents, families, and patient 
        advocacy and support groups; ]
          (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;
          (4) to establish, maintain, and operate a system to 
        assess and coordinate [followup] follow-up and 
        treatment relating to congenital, genetic, and 
        metabolic disorders, including re-engaging patients who 
        have not received recommended follow-up services and 
        supports; and
          (5) to improve the timeliness of--
                  (A) the collection, delivery, receipt, and 
                screening of specimens; and
                  (B) the diagnosis of heritable disorders in 
                newborns.
  (b) 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 political 
        subdivisions of States;
          (3) a territory;
          (4) a health facility or program operated by or 
        pursuant to a contract with or grant from the Indian 
        Health Service; or
          (5) any other entity with appropriate expertise in 
        newborn screening, as determined by the Secretary.
  (c) Approval Factors.--An application for a grant under this 
section shall not be approved by the Secretary unless the 
application contains assurances that the eligible entity has 
adopted and implemented, is in the process of adopting and 
implementing, [or will use] will use amounts received under 
such grant to adopt and implement, or will use amounts received 
under such grant to enhance capacity and infrastructure to 
facilitate the adoption of, the guidelines and recommendations 
of the Advisory Committee that are adopted by the Secretary and 
in effect at the time the grant is awarded or renewed under 
this section, which shall include the screening of each newborn 
for the heritable disorders recommended by the Advisory 
Committee and adopted by the Secretary.
  (d) Coordination.--The Secretary shall take all necessary 
steps to coordinate programs funded with grants received under 
this section and to coordinate with existing newborn screening 
activities.
  (e) Limitation.--An eligible entity may not use amounts 
received under this section to--
          (1) provide cash payments to or on behalf of affected 
        individuals;
          (2) provide inpatient services;
          (3) purchase land or make capital improvements to 
        property; or
          (4) provide for proprietary research or training.
  (f) Voluntary Participation.--The participation by any 
individual in any program or portion thereof established or 
operated with funds received under this section shall be wholly 
voluntary and shall not be a prerequisite to eligibility for or 
receipt of any other service or assistance from, or to 
participation in, another Federal or State program.
  (g) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other 
Federal, State, and local public funds provided for activities 
of the type described in this section.
  (h) Publication.--
          (1) In general.--An application for a grant under 
        this section shall be made public by the State in such 
        a manner as to facilitate comment from any person, 
        including through hearings and other methods used to 
        facilitate comments from the public.
          (2) Comments.--Comments received by the State after 
        the publication described in paragraph (1) shall be 
        addressed in the application for a grant under this 
        section.
  (i) Technical Assistance.--The Secretary shall provide to 
entities receiving grants under subsection (a) such technical 
assistance as may be necessary to ensure the quality of 
programs conducted under this section.

           *       *       *       *       *       *       *


SEC. 1111. ADVISORY COMMITTEE ON HERITABLE DISORDERS IN NEWBORNS AND 
                    CHILDREN.

  (a) Establishment.--The Secretary shall establish an advisory 
committee to be known as the ``Advisory Committee on Heritable 
Disorders in Newborns and Children'' (referred to in this 
section as the ``Advisory Committee'').
  (b) Duties.--The Advisory Committee shall--
          (1) provide advice and recommendations to the 
        Secretary concerning grants and projects awarded or 
        funded under section 1109;
          (2) provide technical information to the Secretary 
        for the development of policies and priorities for the 
        administration of grants under section 1109;
          (3) make systematic evidence-based and peer-reviewed 
        recommendations that include the heritable disorders 
        that have the potential to significantly impact public 
        health for which all newborns should be screened, 
        including secondary conditions that may be identified 
        as a result of the laboratory methods used for 
        screening;
          (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 and adopt process 
        improvements, 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;
          (6) develop a model decision-matrix for newborn 
        screening expansion, including an evaluation of the 
        potential public health impact, including the cost of 
        such expansion, and periodically update the recommended 
        uniform screening panel, as appropriate, based on such 
        decision-matrix;
          (7) consider ways to ensure that all States attain 
        the capacity to screen for the conditions described in 
        paragraph (3), and include in such consideration the 
        results of grant funding under section 1109; [and]
          (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
          [(8)] (9) provide such recommendations, advice or 
        information as may be necessary to enhance, expand or 
        improve the ability of the Secretary to reduce the 
        mortality or morbidity from heritable disorders, which 
        may include recommendations, advice, or information 
        dealing with--
                  (A) follow-up activities, including those 
                necessary to achieve best practices in rapid 
                diagnosis and appropriate treatment in the 
                short-term, and those that ascertain long-term 
                case management outcomes and appropriate access 
                to related services;
                  (B) implementation, monitoring, and 
                evaluation of newborn screening activities, 
                including diagnosis, screening, follow-up, and 
                treatment activities;
                  (C) diagnostic and other technology used in 
                screening;
                  (D) the availability and reporting of testing 
                for conditions for which there is no existing 
                treatment, including information on cost and 
                incidence;
                  (E) conditions not included in the 
                recommended uniform screening panel that are 
                treatable with Food and Drug Administration-
                approved products or other safe and effective 
                treatments, as determined by scientific 
                evidence and peer review;
                  (F) minimum standards and related policies 
                and procedures used by State newborn screening 
                programs, such as language and terminology used 
                by State newborn screening programs to include 
                standardization of case definitions and names 
                of disorders for which newborn screening tests 
                are performed;
                  (G) quality assurance, oversight, and 
                evaluation of State newborn screening programs, 
                including ensuring that tests and technologies 
                used by each State meet established standards 
                for detecting and reporting positive screening 
                results;
                  (H) public and provider awareness and 
                education;
                  (I) the cost and effectiveness of newborn 
                screening and medical evaluation systems and 
                intervention programs conducted by State-based 
                programs;
                  (J) identification of the causes of, public 
                health impacts of, and risk factors for 
                heritable disorders;
                  (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;
                  [(K)] (L) coordination of surveillance 
                activities, including standardized data 
                collection and reporting, harmonization of 
                laboratory definitions for heritable disorders 
                and testing results, and confirmatory testing 
                and verification of positive results, in order 
                to assess and enhance monitoring of newborn 
                diseases; and
                  [(L)] (M) 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.
  (c) Membership.--
          (1) In general.--The Secretary shall appoint not to 
        exceed 15 members to the Advisory Committee. In 
        appointing such members, the Secretary shall ensure 
        that the total membership of the Advisory Committee is 
        an odd number.
          (2) Required members.--The Secretary shall appoint to 
        the Advisory Committee under paragraph (1)--
                  (A) the Administrator of the Health Resources 
                and Services Administration;
                  (B) the Director of the Centers for Disease 
                Control and Prevention;
                  (C) the Director of the National Institutes 
                of Health;
                  (D) the Director of the Agency for Healthcare 
                Research and Quality;
                  (E) the Commissioner of the Food and Drug 
                Administration;
                  (F) medical, technical, or scientific 
                professionals with special expertise in 
                heritable disorders, or in providing screening, 
                counseling, testing or specialty services for 
                newborns and children at risk for heritable 
                disorders;
                  (G) individuals with expertise in ethics and 
                infectious diseases who have worked and 
                published material in the area of newborn 
                screening;
                  (H) members of the public having special 
                expertise about or concern with heritable 
                disorders; and
                  (I) representatives from such Federal 
                agencies, public health constituencies, and 
                medical professional societies as determined to 
                be necessary by the Secretary, to fulfill the 
                duties of the Advisory Committee, as 
                established under subsection (b).
  (d) Decision on Recommendations.--
          (1) In general.--Not later than 120 days after the 
        Advisory Committee issues a recommendation pursuant to 
        this section, the Secretary shall adopt or reject such 
        recommendation. 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.
          (2) Determinations to be made public.--The Secretary 
        shall publicize any determination on adopting or 
        rejecting a recommendation of the Advisory Committee 
        pursuant to this subsection, including the 
        justification for the determination.
          (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.
  (e) Annual Report.--Not later than 3 years after the date of 
enactment of the Newborn Screening Saves Lives Act of 2008, and 
each fiscal year thereafter, the Advisory Committee shall--
          (1) publish a report on peer-reviewed newborn 
        screening guidelines, including follow-up and 
        treatment, in the United States;
          (2) submit such report to the appropriate committees 
        of Congress, the Secretary, the Interagency 
        Coordinating Committee established under Section 1114, 
        and the State departments of health; and
          (3) disseminate such report on as wide a basis as 
        practicable, including through posting on the internet 
        clearinghouse established under section 1112.
  (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.
  (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] 2024.
          (2) Continuation if not reauthorized.--If at the end 
        of fiscal year [2019] 2024 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.

SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.

  (a) In General.--The Secretary, acting through the 
Administrator of the Health Resources and Services 
Administration (referred to in this part as the 
``Administrator''), in consultation with the Director of the 
Centers for Disease Control and Prevention and the Director of 
the National Institutes of Health, shall establish and maintain 
a central clearinghouse of current educational and family 
support and services information, materials, resources, 
research, and data on newborn screening to--
          (1) enable parents and family members of newborns, 
        health professionals, industry representatives, and 
        other members of the public to increase their 
        awareness, knowledge, and understanding of newborn 
        screening;
          (2) increase awareness, knowledge, and understanding 
        of newborn diseases and screening services for 
        expectant individuals and families;
          (3) maintain current information on quality 
        indicators to measure performance of newborn screening, 
        such as false-positive rates and other quality 
        indicators as determined by the Advisory Committee 
        under section 1111;
          (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.
  (b) Internet Availability.--The Secretary, acting through the 
Administrator, shall ensure that the clearinghouse described 
under subsection (a)--
          (1) is available on the Internet;
          (2) includes an interactive forum;
          (3) is updated on a regular basis, but not less than 
        quarterly; and
          (4) provides--
                  (A) links to Government-sponsored, non-
                profit, and other Internet websites of 
                laboratories that have demonstrated expertise 
                in newborn screening that supply research-based 
                information on newborn screening tests 
                currently available throughout the United 
                States;
                  (B) information about newborn conditions and 
                screening services available in each State from 
                laboratories certified under subpart 2 of part 
                F of title III, including information about 
                supplemental screening that is available but 
                not required, in the State where the infant is 
                born;
                  (C) current research on both treatable and 
                not-yet treatable conditions for which newborn 
                screening tests are available;
                  (D) the availability of Federal funding for 
                newborn and child screening for heritable 
                disorders including grants authorized under the 
                Newborn Screening Saves Lives Reauthorization 
                Act of 2014; and
                  (E) other relevant information as determined 
                appropriate by the Secretary.
  (c) Nonduplication.--In carrying out activities under this 
section, the Secretary shall ensure that such activities 
minimize duplication [and supplement, not supplant, existing 
information sharing efforts] and complement other Federal 
newborn screening information sharing activities.

SEC. 1113. LABORATORY QUALITY AND SURVEILLANCE.

  (a) In General.--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--
          (1) quality assurance for laboratories involved in 
        screening newborns and children for heritable 
        disorders, including quality assurance for newborn-
        screening tests, timeliness for processing such tests, 
        [performance evaluation services,] development of new 
        screening tests, and technical assistance and 
        technology transfer to newborn screening laboratories 
        to ensure analytic validity and utility of screening 
        tests; [and]
          (2) appropriate quality control and other 
        [performance test materials] test performance materials 
        to evaluate the performance of new screening tools[.]; 
        and
          (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.
  [(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.]
  (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. 1116. HUNTER KELLY RESEARCH PROGRAM.

  (a) Newborn Screening Activities.--
          (1) In general.--The Secretary, in conjunction with 
        the Director of the National Institutes of Health and 
        taking into consideration the recommendations of the 
        Advisory Committee, [may] shall continue carrying out, 
        coordinating, and expanding research in newborn 
        screening (to be known as ``Hunter Kelly Newborn 
        Screening Research Program'') including--
                  (A) identifying, developing, and testing the 
                most promising new screening technologies, in 
                order to improve already existing screening 
                tests, increase the specificity of newborn 
                screening, and expand the number of conditions 
                for which screening tests are available;
                  (B) experimental treatments and disease 
                management strategies for additional newborn 
                conditions, and other genetic, metabolic, 
                hormonal, or functional conditions that can be 
                detected through newborn screening for which 
                treatment is not yet available;
                  (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, or with a high probability of 
                being recommended by, the Advisory Committee on 
                Heritable Disorders in Newborns and Children to 
                ensure [that screenings are ready for 
                nationwide implementation] that reliable 
                newborn screening technologies are evaluated 
                and ready for use; and
                  (E) other activities that would improve 
                newborn screening, as identified by the 
                Director.
          (2) Additional newborn condition.--For purposes of 
        this subsection, the term ``additional newborn 
        condition'' means any condition that is not one of the 
        core conditions recommended by the Advisory Committee 
        and adopted by the Secretary.
  [(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 the appropriate State departments of health, 
and, as practicable, focus their research on screening 
technology not currently performed in the States in which the 
entities are located, and the conditions on the uniform 
screening panel (or the standard test existing on the uniform 
screening panel).]
  (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.
  (c) Reports.--The Director is encouraged to include 
information about the activities carried out under this section 
in the biennial report required under section 403. If such 
information is included, the Director shall make such 
information available to be included on the Internet 
Clearinghouse established under section 1112.
  (d) Nonduplication.--In carrying out programs under this 
section, the Secretary shall minimize duplication and 
supplement, not supplant, existing efforts of the type carried 
out under this section.
  (e) Peer Review.--Nothing in this section shall be construed 
to interfere with the scientific peer-review process at the 
National Institutes of Health.

SEC. 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] $31,000,000 for each of fiscal years 
        [2015] 2020 through [2019] 2024; and
          (2) to carry out section 1113, [$8,000,000] 
        $29,650,000 for each of fiscal years [2015] 2020 
        through [2019] 2024.

           *       *       *       *       *       *       *

                              ----------                              


       NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2014



           *       *       *       *       *       *       *
[SEC. 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.]

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.).

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