[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.

                          ____________________