[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
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``(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
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$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.
____________________