[Congressional Record Volume 167, Number 108 (Tuesday, June 22, 2021)]
[House]
[Pages H2940-H2942]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2021
Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 482) to amend the Public Health Service Act to reauthorize
certain programs under part A of title XI of such Act relating to
genetic diseases, and for other purposes.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 482
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Newborn Screening Saves
Lives Reauthorization Act of 2021''.
SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND FOLLOW-UP
FOR HERITABLE DISORDERS.
(a) Purposes.--Section 1109(a) of the Public Health Service
Act (42 U.S.C. 300b-8(a)) is amended--
(1) in paragraph (1), by striking ``enhance, improve or''
and inserting ``facilitate, enhance, improve, or'';
(2) by amending paragraph (3) to read as follows:
``(3) to develop, and deliver to parents, families, and
patient advocacy and support groups, educational programs
that--
``(A) address newborn screening counseling, testing
(including newborn screening pilot studies), follow-up,
treatment, specialty services, and long-term care;
``(B) assess the target audience's current knowledge,
incorporate health communications strategies, and measure
impact; and
``(C) are at appropriate literacy levels;''; and
(3) in paragraph (4)--
(A) by striking ``followup'' and inserting ``follow-up'';
and
(B) by inserting before the semicolon at the end the
following: ``, including re-engaging patients who have not
received recommended follow-up services and supports''.
(b) Approval Factors.--Section 1109(c) of the Public Health
Service Act (42 U.S.C. 300b-8(c)) is amended--
(1) by striking ``or will use'' and inserting ``will use'';
and
(2) by inserting ``, or will use amounts received under
such grant to enhance capacity and infrastructure to
facilitate the adoption of,'' before ``the guidelines and
recommendations''.
SEC. 3. ADVISORY COMMITTEE ON HERITABLE DISORDERS IN NEWBORNS
AND CHILDREN.
Section 1111 of the Public Health Service Act (42 U.S.C.
300b-10) is amended--
(1) in subsection (b)--
(A) in paragraph (5), by inserting ``and adopt process
improvements'' after ``take appropriate steps'';
(B) in paragraph (7) by striking ``and'' at the end;
(C) by redesignating paragraph (8) as paragraph (9);
(D) by inserting after paragraph (7) the following:
``(8) develop, maintain, and publish on a publicly
accessible website consumer-friendly materials detailing--
``(A) the uniform screening panel nomination process,
including data requirements, standards, and the use of
international data in nomination submissions; and
``(B) the process for obtaining technical assistance for
submitting nominations to the uniform screening panel and
detailing the instances in which the provision of technical
assistance would introduce a conflict of interest for members
of the Advisory Committee; and'';
(E) in paragraph (9), as redesignated--
(i) by redesignating subparagraphs (K) and (L) as
subparagraphs (L) and (M), respectively; and
(ii) by inserting after subparagraph (J) the following:
``(K) the appropriate and recommended use of safe and
effective genetic testing by health care professionals in
newborns and children with an initial diagnosis of a disease
or condition characterized by a variety of genetic causes and
manifestations;''; and
(2) in subsection (g)--
(A) in paragraph (1) by striking ``2019'' and inserting
``2026''; and
(B) in paragraph (2) by striking ``2019'' and inserting
``2026''.
SEC. 4. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.
Section 1112(c) of the Public Health Service Act (42 U.S.C.
300b-11(c)) is amended by striking ``and supplement, not
supplant, existing information sharing efforts'' and
inserting ``and complement other Federal newborn screening
information sharing activities''.
SEC. 5. LABORATORY QUALITY AND SURVEILLANCE.
Section 1113 of the Public Health Service Act (42 U.S.C.
300b-12) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by striking ``performance evaluation services,'' and
inserting ``development of new screening tests,''; and
(ii) by striking ``and'' at the end;
(B) in paragraph (2)--
(i) by striking ``performance test materials'' and
inserting ``test performance materials''; and
(ii) by striking the period at the end and inserting ``;
and''; and
(C) by adding at the end the following:
``(3) performance evaluation services to enhance disease
detection, including the development of tools, resources, and
infrastructure to improve data analysis, test result
interpretation, data harmonization, and dissemination of
laboratory best practices.''; and
(2) in subsection (b) to read as follows:
``(b) Surveillance Activities.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, and taking into consideration the expertise of
the Advisory Committee on Heritable Disorders in Newborns and
Children established under section 1111, shall provide for
the coordination of national surveillance activities,
including--
``(1) standardizing data collection and reporting through
the use of electronic and other forms of health records to
achieve real-time data for tracking and monitoring the
newborn screening system, from the initial positive screen
through diagnosis and long-term care management; and
``(2) by promoting data sharing linkages between State
newborn screening programs and State-based birth defects and
developmental disabilities surveillance programs to help
families connect with services to assist in evaluating long-
term outcomes.''.
SEC. 6. HUNTER KELLY RESEARCH PROGRAM.
Section 1116 of the Public Health Service Act (42 U.S.C.
300b-15) is amended--
(1) in subsection (a)(1)--
(A) by striking ``may'' and inserting ``shall''; and
(B) in subparagraph (D)--
(i) by inserting ``, or with a high probability of being
recommended by,'' after ``recommended by''; and
(ii) by striking ``that screenings are ready for nationwide
implementation'' and inserting ``that reliable newborn
screening technologies are piloted and ready for use''; and
(2) in subsection (b) to read as follows:
``(b) Funding.--In carrying out the research program under
this section, the Secretary and the Director shall ensure
that entities receiving funding through the program will
provide assurances, as practicable, that such entities will
work in consultation with State departments of health, as
appropriate.''.
SEC. 7. AUTHORIZATION OF APPROPRIATIONS FOR NEWBORN SCREENING
PROGRAMS AND ACTIVITIES.
Section 1117 of the Public Health Service Act (42 U.S.C.
300b-16) is amended--
(1) in paragraph (1)--
(A) by striking ``$11,900,000'' and inserting
``$31,000,000'';
(B) by striking ``2015'' and inserting ``2022''; and
(C) by striking ``2019'' and inserting ``2026''; and
(2) in paragraph (2)--
(A) by striking ``$8,000,000'' and inserting
``$29,650,000'';
(B) by striking ``2015'' and inserting ``2022''; and
(C) by striking ``2019'' and inserting ``2026''.
SEC. 8. INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE PROGRAM.
Section 12 of the Newborn Screening Saves Lives
Reauthorization Act of 2014 (42 U.S.C. 289 note) is amended
to read as follows:
``SEC. 12. INSTITUTIONAL REVIEW BOARDS; ETHICS GUIDANCE
PROGRAM.
``Research on nonidentified newborn dried blood spots shall
be considered secondary research (as that term is defined in
section 46.104(d)(4) of title 45, Code of Federal Regulations
(or successor regulations)) with nonidentified biospecimens
for purposes of federally funded research conducted pursuant
to the Public Health Service Act (42 U.S.C. 200 et seq.).''.
SEC. 9. NAM REPORT ON THE MODERNIZATION OF NEWBORN SCREENING.
(a) Study.--Not later than 60 days after the date of the
enactment of this Act, the Secretary of Health and Human
Services shall seek to enter into an agreement with the
National Academy of Medicine (in this section referred to as
``NAM'') (or if NAM declines to enter into such an agreement,
another appropriate entity) under which NAM, or such other
appropriate entity, agrees to conduct a study on the
following:
(1) The uniform screening panel review and recommendation
processes to identify factors that impact decisions to add
new conditions to the uniform screening panel, to describe
challenges posed by newly nominated conditions, including
low-incidence diseases, late onset variants, and new
treatments without long-term efficacy data.
(2) The barriers that preclude States from adding new
uniform screening panel conditions to their State screening
panels with recommendations on resources needed to help
States implement uniform screening panel recommendations.
(3) The current state of federally and privately funded
newborn screening research with recommendations for
optimizing the capacity of this research, including piloting
multiple prospective conditions at once and addressing rare
disease questions.
(4) New and emerging technologies that would permit
screening for new categories of disorders, or would make
current screening more effective, more efficient, or less
expensive.
[[Page H2941]]
(5) Technological and other infrastructure needs to improve
timeliness of diagnosis and short- and long-term follow-up
for infants identified through newborn screening and improve
public health surveillance.
(6) Current and future communication and educational needs
for priority stakeholders and the public to promote
understanding and knowledge of a modernized newborn screening
system with an emphasis on evolving communication channels
and messaging.
(7) The extent to which newborn screening yields better
data on the disease prevalence for screened conditions and
improves long-term outcomes for those identified through
newborn screening, including existing systems supporting such
data collection and recommendations for systems that would
allow for improved data collection.
(8) The impact on newborn morbidity and mortality in States
that adopt newborn screening tests included on the uniform
panel.
(b) Public Stakeholder Meeting.--In the course of
completing the study described in subsection (a), NAM or such
other appropriate entity shall hold not less than one public
meeting to obtain stakeholder input on the topics of such
study.
(c) Report.--Not later than 18 months after the effective
date of the agreement under subsection (a), such agreement
shall require NAM, or such other appropriate entity, to
submit to the Secretary of Health and Human Services and the
appropriate committees of jurisdiction of Congress a report
containing--
(1) the results of the study conducted under subsection
(a);
(2) recommendations to modernize the processes described in
subsection (a)(1); and
(3) recommendations for such legislative and administrative
action as NAM, or such other appropriate entity, determines
appropriate.
(d) Authorization of Appropriations.--There is authorized
to be appropriated $2,000,000 for the period of fiscal years
2022 and 2023 to carry out this section.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New
Jersey (Mr. Pallone) and the gentleman from Michigan (Mr. Walberg) 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. 482.
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, I rise today in support of H.R. 482, the Newborn
Screening Saves Lives Reauthorization Act of 2021.
Newborn screening is a well-established and proven public health
program that identifies certain genetic and functional conditions in
newborns. Each year, almost all of the 3.8 million babies born in the
U.S. are screened for medical conditions that can cause serious
disability or death if not detected and treated early.
Newborn screening includes blood, hearing, and heart screening. While
most families may likely forget this routine testing ever took place,
more than 12,000 families each year will be notified of a positive
screening result and referred for immediate diagnosis and treatment.
Many of these families might not have considered or had access to these
tests without newborn screening. Newborns can appear healthy but,
without warning, can quickly deteriorate due to these undetected
conditions, and that is why these tests are so critical. If diagnosed
early, many of these conditions can be treated and managed
successfully.
In 2008, the original Newborn Screening Saves Lives Act was signed
into law. It established national newborn screening guidelines and
supported the facilitation of newborn screening at the State level.
Before 2008, only 10 States and the District of Columbia required
newborn screening for recommended disorders. Today, all 50 States and
D.C. screen for most or all of these recommended diseases.
This bipartisan program was reauthorized in 2014 and 2019. Those
reauthorizations renewed Federal support to help States to expand and
improve their newborn screening programs.
H.R. 482, before us today, once again renews Federal funds and
activities to assist States in continuing and improving their newborn
screening programs. This bill also supports parent and provider
education and laboratory quality and surveillance.
Newborn screening, Mr. Speaker, is a simple set of tests that can
improve and save the lives of thousands of babies so that they and
their families can grow to live healthy and happy lives. Through the
national expansion of these life-saving health screenings, no baby
should receive inadequate care because of the State that they live in.
With the continuous reauthorization of the Newborn Screening Saves
Lives Act, every baby in the U.S. can have access to equitable
healthcare from the day they are born.
I commend the steadfast champions of this bipartisan legislation--
foremost, Representative Lucille Roybal-Allard, who has been working on
this for such a long time, and this is something that she and I have
talked about quite a bit, and Congressman Simpson, Congresswoman
Herrera Beutler, and Assistant Speaker Katherine Clark for their
ongoing commitment and leadership toward eliminating preventable
newborn deaths. No newborn should suffer or die from a condition that
can be detected and treated by newborn screening.
Mr. Speaker, I urge my colleagues to support this legislation, and I
reserve the balance of my time.
Mr. GUTHRIE. Mr. Speaker, I ask unanimous consent to control the time
on this bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Kentucky?
There was no objection.
Mr. GUTHRIE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of H.R. 482, the Newborn
Screening Saves Lives Reauthorization Act of 2021.
Newborn screening is critical in the early detection and intervention
of health conditions, some life-threatening, for our Nation's infants.
They 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. However, if not detected and left untreated, these
conditions can impact a child for the rest of their life by causing
disabilities, developmental delays, illness, or even death.
Prior to the passage of the first Newborn Screening Saves Lives Act
in 2008, which helped better standardize screening programs, States had
varying standards for newborn screening, and they were not screening
for many of the core conditions on the Recommended Uniform Screening
Panel.
This bill authorizes 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.
Specifically, H.R. 482 reauthorizes grants through the Health
Resources and Services Administration to expand State screening
programs and improve follow-up care after a detection, in addition to
allowing for the National Institutes of Health Hunter Kelly Newborn
Screening program to continue to identify new treatments for conditions
detected by newborn screening.
The importance of newborn screenings can't be overstated. Screening
provides physicians and families with critical information regarding
infant health, allowing for early intervention and treatment,
if necessary.
I urge my fellow Members to support H.R. 482, and I reserve 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 prime sponsor of
this legislation.
Ms. ROYBAL-ALLARD. Mr. Speaker, I rise to support reauthorization of
my Newborn Screening Saves Lives Act. I thank Chairman Pallone for his
support and for bringing my bill to the floor.
My sincere gratitude to my newborn screening partners and colleagues,
Mike Simpson, Katherine Clark, and Jaime Herrera Beutler, and my
heartfelt appreciation to the public health groups that continue to
support my newborn screening efforts, including the March of Dimes, the
Association of Public Health Laboratories, the Muscular Dystrophy
Association, and
[[Page H2942]]
the National Organization for Rare Disorders.
Newborn screening involves a baby receiving a simple blood test to
identify life-threatening diseases before symptoms begin. Prior to the
development of these tests, children would die or suffer lifelong
disabilities.
In 2008, when my original bill passed, newborn screenings and access
to follow-up information were not consistent or available to families
in all communities. Only 10 States and the District of Columbia
required screening for a complete panel of recommended disorders, and
there was no Federal repository of information on the diseases.
Today, all 50 States and D.C. screen for at least 30 of the 35
recommended core conditions, and a national clearinghouse has the most
recent newborn screening information available to parents and
professionals.
Newborn screening is a public health success story that makes 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 conditions, babies like Cruz, a beautiful little girl born on
February 4 this year to one of my district office deputies. Thanks to
newborn screening, in just 4 days, Cruz was diagnosed with maple syrup
urine disease, which prevents the body from breaking down certain amino
acids typically obtained from protein.
If Cruz's disease had gone undetected, the buildup of amino acids in
her body would have become toxic, leading to seizures, swelling of the
brain, coma, and, ultimately, death. Today, the management of her amino
acid levels keeps Cruz out of the hospital, protects her from critical
medical complications, and gives her family the gift of watching their
daughter grow up healthy.
This is just one of the thousands of success stories that illustrate
the critical need to pass H.R. 482 into law. This will guarantee high-
quality technical assistance for State programs and public health labs,
access to the most current programs and educational materials, and it
will ensure the advisory committee continues its work of researching
and recommending new screenings for State programs, which also save our
healthcare system millions of dollars for each child identified and
treated early.
Reauthorization will also commission a National Academy 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. 482 to
ensure all newborns like Cruz are blessed with early, comprehensive,
and consistent testing and follow-up programs for a healthy and
productive life.
{time} 1430
Mr. GUTHRIE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I strongly support this bill and encourage others to do
so. When I first was elected to the State Senate, the General Assembly
of Kentucky, one of the biggest public policy efforts I got involved in
was Governor Patton--our governor at the time--who was proposing a big
0-3 kind of overall for Kentucky's babies and children, and a big part
of it was newborn screenings.
And that was a section I was kind of assigned to look into and I
spent a lot of time doing research--even going down to see a lady who
does this kind of research at Vanderbilt University and walked away
convinced that it is the right public policy to do. It is money well-
spent. It really changes people's ability. If you can't get your
language at an early time, you can never get it back.
So this absolutely prevents--if you want to look at the cost of this
system, this system going forward, but more importantly, it really
enhances people to have the opportunity to live a full life if we catch
it at the youngest level.
So I am convinced of this. I support this bill, and I encourage my
colleagues to do so.
Mr. Speaker, I yield back the balance of my time.
Mr. PALLONE. Mr. Speaker, I would also ask Members to support this
legislation, and I yield back the balance of my time.
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. 482.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds
being in the affirmative, the ayes have it.
Mr. ROSENDALE. Mr. Speaker, on that I demand the yeas and nays.
The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution
8, the yeas and nays are ordered.
Pursuant to clause 8 of rule XX, further proceedings on this motion
are postponed.
____________________