[Congressional Record Volume 165, Number 125 (Wednesday, July 24, 2019)]
[House]
[Pages H7365-H7368]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




       NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2019

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass 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, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows

                               H.R. 2507

       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.

       (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

[[Page H7366]]

       ``(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 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 ``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 
     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

[[Page H7367]]

     $2,000,000 for the period of fiscal years 2020 and 2021 to 
     carry out this section.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Georgia (Mr. Carter) each 
will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and include extraneous material on H.R. 2507.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, every year over 12,000 newborns are born with conditions 
that require early detection and treatment. With proper screening, 
parents can receive education and children can receive appropriate 
follow-up and treatment and, ultimately, better long-term health 
outcomes.
  Over the years, as more screening tests and treatments have become 
available as we have expanded our medical and scientific knowledge, we 
have also seen greater potential for improving outcomes for children.
  However, prior to Congress passing the first Newborn Screening Saves 
Lives Act in 2008, a patchwork of State requirements for screening led 
to some newborns screened for many disorders and others for very few.
  Since the Newborn Screening law was enacted, we have seen tremendous 
progress around the country, with all 50 States screening for at least 
29 recommended conditions. But as we develop new screening tests and 
treatments for diseases once thought untreatable, we must ensure that 
States are able to adopt recommended screening tests more quickly.
  The bill we are considering today will do that by reauthorizing the 
program for 5 years, with higher authorization levels, improved 
processes and pilot testing for new screening tests, and a study 
focused on how we can better modernize newborn screening for the 
future.
  This bipartisan bill will bring us closer to the goal of every child 
born in the United States receiving all recommended screening tests and 
will improve countless lives of the youngest Americans.
  Mr. Speaker, I am proud to support it and ask all of my colleagues to 
join me in passing it today, and I reserve the balance of my time.
  Mr. CARTER of Georgia. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I rise to speak in support of H.R. 2507, the Newborn 
Screening Saves Lives Reauthorization Act of 2019.
  Newborn screening is critical in early detection and intervention for 
conditions, some life-threatening, for our Nation's infants. These 
screenings inform both physicians and the families of a newborn what 
steps may be necessary to treat or prevent further health complications 
as the infant ages.
  The Newborn Screening Saves Lives Act, which passed for the first 
time in 2008, aims to improve the ability to address pediatric health 
by standardizing newborn screening programs.

                              {time}  2200

  Newborn screenings are incredibly important in providing physicians 
and families with information regarding their baby's health, enabling 
them to practice early intervention and treatment, if necessary.
  According to the March of Dimes, in 2017, only 10 States and 
Washington, D.C., required infant screening for the recommended 
disorders.
  Since enactment of the Newborn Screening Saves Lives Act, all the 
States, D.C., and Puerto Rico screen for at least 29 of the 35 
recommended conditions.
  This bill would reauthorize funding for the Health Resources and 
Services Administration, the Centers for Disease Control and 
Prevention, and the National Institutes of Health to ensure that our 
newborn screening remains comprehensive and that our Nation's 
healthcare providers are adequately equipped to conduct the screenings.
  Newborn screenings are for serious but rare conditions that families 
and doctors may otherwise be unable to detect at birth.
  Newborns are screened in the hospital when they are 1 or 2 days old 
by blood tests, in addition to hearing and heart screenings. About 1 in 
300 newborns has a condition that can be detected via newborn 
screening.
  By catching these disorders early, many can be managed successfully, 
allowing children to live fuller, better lives. However, if not 
detected and left untreated, these conditions can impact a child for 
the rest of their life by causing disabilities, delays in development, 
illness, or even death.
  Prior to the passage of the initial bill in 2008, States had varying 
standards for newborn screening. Some States were only screening for 4 
conditions in 2002, when other States were screening for more than 30.
  Reauthorizing the Newborn Screening Saves Lives Act will allow the 
CDC to work with States to continue to level the playing field and 
provide for equal access to newborn screenings across the country.
  H.R. 2507 also reauthorizes grants through the Health Resources and 
Services Administration that not only allows for expansion of screening 
programs but improved follow-up care after a detection.
  The bill also allows for the continuation of the National Institutes 
of Health Hunter Kelly Newborn Screening program, which helps to 
identify new treatments for conditions detected in newborn screenings.
  I applaud Representatives Roybal-Allard and Simpson for their work on 
this bill, and I urge my fellow Members to support H.R. 2507.
  Mr. Speaker, I have no further speakers at this time. I urge passage 
of this bill, and I yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield such time as she may consume to the 
gentlewoman from California (Ms. Roybal-Allard), the chairwoman of the 
Homeland Security Appropriations Subcommittee.
  Ms. ROYBAL-ALLARD. Mr. Speaker, I rise to support reauthorization of 
my Newborn Screening Saves Lives Act, which I first introduced in 2002.
  Let me begin by extending my sincere gratitude to Congressman  Mike 
Simpson for our 15-year partnership championing newborn screening. Many 
thanks to Congresswomen Katherine Clark and Jaime Herrera Beutler who, 
this year, joined us as House champions. And my heartfelt appreciation 
to the coalition of public health groups, who continue to support my 
newborn screening efforts, especially the March of Dimes and the APHL.
  Newborn screening involves a baby receiving a simple blood test to 
identify life-threatening diseases before symptoms begin. Prior to the 
first newborn screening test being developed, these children would have 
died or suffered lifelong disabilities.
  And, until enactment of my original newborn screening bill in 2008, 
newborn screenings and access to follow-up information were not 
consistent and available to families in all communities. At that time, 
only 10 States and the District of Columbia required infants to be 
screened for a complete panel of recommended disorders, and there was 
no Federal repository of information on the diseases.
  Today, 49 States and D.C. require screening of at least 31 of the 35 
core treatable conditions, and a national clearinghouse of newborn 
screening information is available for parents and professionals.
  Rapid identification and treatment make the difference between health 
and disability--or even life and death--for the approximately 12,000 
babies who, each year, test positive for one of these serious 
conditions.
  In addition, this simple test saves our healthcare system millions of 
dollars in care for each child who is identified and treated early.
  This truly public health success story exemplifies what can be 
accomplished when private and public institutions, industry, advocates, 
scientists, providers, and parents partner to ensure a healthier future 
for our children.
  Mr. Speaker, to maintain and advance the incredible progress that we 
have made over the last decade, we must reauthorize the Newborn 
Screening Saves Lives Act.
  Passing H.R. 2507 will ensure the advisory committee continues its 
critical

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work of recommending new screenings to State programs. It will 
guarantee access to the most current follow-up programs and educational 
materials for parents and providers, as well as high-quality technical 
assistance for State programs and public health labs.
  Reauthorization will also commission a National Academies of Sciences 
study to make recommendations for a 21st century newborn screening 
system.
  Mr. Speaker, I urge a ``yes'' vote on the passage of H.R. 2507 to 
ensure all our newborns receive the comprehensive and consistent 
testing and follow up that they will need for a healthy and productive 
life.
  Mr. PALLONE. Mr. Speaker, I have no additional speakers. I would ask 
my colleagues, on a bipartisan basis, to support this legislation. I 
thank the sponsor, the chairwoman, and I yield back the balance of my 
time.
  Ms. JACKSON LEE. Mr. Speaker, as a senior member of both the 
Judiciary Committee and the Committee on Homeland Security, I rise in 
strong support of H.R. 2507, the ``Newborn Screening Saves Lives 
Reauthorization Act of 2019.''
  The Newborn Screening Saves Lives Reauthorization Act would yield 
major improvements in both the screening and follow up processes 
involved in the testing of infants for heritable diseases and 
conditions.
  In the United States, more than 4,000,000 infants and children are 
screened every year, and up to 4,000 of the children test positive for 
one or more disease or disorder.
  Mr. Speaker, 4,000 conditions detected are 4,000 young lives saved, 
as many of the diseases on the uniform screening panel, the list of 
conditions that newborns are tested for, are very treatable but can be 
deadly if left unaddressed.
  However, there is an ever-present need to continue adapting the panel 
of conditions that newborns and young children are tested for, as 
improvements in technology allow medical professionals to identify new 
diseases, sooner.
  Mr. Speaker, children and their families should have access to state 
of the art testing, and treatments.
  H.R. 2507 specifically improves the current Newborn Screening Act in 
several ways, including:
  Creating new educational strategies and practices regarding the 
screening and follow-up treatments for heritable diseases and 
conditions;
  Creating an advisory committee for heritable diseases in newborns and 
children;
  Creating a Clearinghouse of newborn screening information;
  Improving laboratory quality and surveillance, which includes 
implementing new tools, resources and infrastructure, to improve data 
analysis, interpretation and lab practices;
  Increasing funding for the Hunter Kelly Institute; and
  Authorizing $2 million in Appropriations to the National Academy of 
Medicine, to fund studies dedicated to further improving the practice 
and procedure of the Uniform Screening Panel.
  The screening of children has already been proven to be effective, 
and improvements and additions to the panel of diseases that are tested 
for can only result in more lives being saved.
  I urge all members to join me in voting to pass H.R. 2507, the 
``Newborn Screening Saves Lives Reauthorization Act of 2019.''
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, H.R. 2507, as amended.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill, as amended, was passed.
  A motion to reconsider was laid on the table.

                          ____________________