[Congressional Record Volume 160, Number 99 (Tuesday, June 24, 2014)]
[House]
[Pages H5696-H5699]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
NEWBORN SCREENING SAVES LIVES REAUTHORIZATION ACT OF 2014
Mr. PITTS. Mr. Speaker, I move to suspend the rules and pass the bill
(H.R. 1281) to amend the Public Health Service Act to reauthorize
programs under part A of title XI of such Act, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 1281
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Newborn
Screening Saves Lives Reauthorization Act of 2014''.
(b) Table of Contents.--The table of contents of this Act
is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Improved newborn and child screening and followup for heritable
disorders.
Sec. 3. Evaluating the effectiveness of newborn and child screening and
followup programs.
Sec. 4. Advisory Committee on Heritable Disorders in Newborns and
Children.
Sec. 5. Clearinghouse of Newborn Screening Information.
Sec. 6. Laboratory quality and surveillance.
Sec. 7. Interagency Coordinating Committee on Newborn and Child
Screening.
Sec. 8. National contingency plan for newborn screening.
Sec. 9. Hunter Kelly Research Program.
Sec. 10. Authorization of appropriations.
Sec. 11. Reports to Congress.
SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING AND FOLLOWUP FOR
HERITABLE DISORDERS.
Section 1109 of the Public Health Service Act (42 U.S.C.
300b-8) is amended--
(1) in subsection (a)--
(A) in the matter preceding paragraph (1)--
(i) by striking ``subsection (j)'' and inserting ``section
1117''; and
(ii) by striking ``and in consultation with the Advisory
Committee'' and inserting ``and taking into consideration the
expertise of the Advisory Committee'';
(B) by amending paragraph (2) to read as follows:
``(2) to assist in providing health care professionals and
newborn screening laboratory personnel with education in
newborn screening, counseling, and training in--
``(A) relevant and new technologies in newborn screening
and congenital, genetic, and metabolic disorders;
``(B) the importance of the timeliness of collection,
delivery, receipt, and screening of specimens; and
``(C) sharing of medical and diagnostic information with
providers and families;'';
(C) in paragraph (3), by striking ``and'' at the end;
(D) in paragraph (4)--
(i) by striking ``treatment'' and inserting ``followup and
treatment''; and
(ii) by striking the period and inserting ``; and''; and
(E) by adding at the end the following:
``(5) to improve the timeliness of--
``(A) the collection, delivery, receipt, and screening of
specimens; and
``(B) the diagnosis of heritable disorders in newborns.'';
(2) in subsection (c), by striking ``application submitted
for a grant under subsection (a)(1)'' and inserting
``application for a grant under this section'';
(3) in subsection (h), by striking ``application submitted
under subsection (c)(2)'' each place it appears and inserting
``application for a grant under this section''; and
(4) by striking subsection (j) (relating to authorization
of appropriations).
SEC. 3. EVALUATING THE EFFECTIVENESS OF NEWBORN AND CHILD
SCREENING AND FOLLOWUP PROGRAMS.
Section 1110 of the Public Health Service Act (42 U.S.C.
300b-9) is amended--
(1) in the section heading, by inserting ``and followup''
after ``child screening'';
(2) in subsection (a), by striking ``of screening,'' and
inserting ``, including with respect to timeliness, of
screening, followup,'';
(3) in subsection (b)--
(A) in paragraph (1)--
(i) by striking ``counseling, testing'' and inserting
``treatment, counseling, testing, followup,''; and
(ii) by inserting before the semicolon the following: ``,
including, as appropriate, through the assessment of health
and development outcomes for such children through
adolescence'';
(B) in paragraph (2)--
(i) by striking ``counseling, testing'' and inserting
``treatment, counseling, testing, followup,'';
(ii) by inserting ``in a timely manner'' after ``in
newborns and children''; and
(iii) by striking ``or'' at the end;
(C) in paragraph (3), by striking the period at the end and
inserting a semicolon; and
(D) by adding at the end the following:
``(4) methods that may be identified to improve quality in
the diagnosis, treatment, and disease management of heritable
disorders based on gaps in services or care; or
``(5) methods or best practices by which the eligible
entities described in section 1109 can achieve in a timely
manner--
``(A) collection, delivery, receipt, and screening of
newborn screening specimens; and
``(B) diagnosis of heritable disorders in newborns.''; and
(4) by striking subsection (d) (relating to authorization
of appropriations).
SEC. 4. 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) by redesignating paragraphs (4) through (6) as
paragraphs (6) through (8), respectively;
(B) by inserting after paragraph (3), the following:
``(4) provide technical assistance, as appropriate, to
individuals and organizations regarding the submission of
nominations to the uniform screening panel, including prior
to the submission of such nominations;
``(5) take appropriate steps, at its discretion, to prepare
for the review of nominations prior to their submission,
including for conditions for which a screening method has
been validated but other nomination criteria are not yet met,
in order to facilitate timely action by the Advisory
Committee once such submission has been received by the
Committee;'';
(C) in paragraph (6) (as so redesignated), by inserting ``,
including the cost'' after ``public health impact''; and
(D) in paragraph (8) (as so redesignated)--
(i) in subparagraph (A), by striking ``achieve rapid
diagnosis'' and inserting ``achieve best practices in rapid
diagnosis and appropriate treatment'';
(ii) in subparagraph (D), by inserting before the semicolon
``, including information on cost and incidence'';
(iii) in subparagraph (J), by striking ``and'' at the end;
(iv) in subparagraph (K), by striking the period and
inserting ``; and''; and
(v) by adding at the end the following:
``(L) the timeliness of collection, delivery, receipt, and
screening of specimens to be tested for heritable disorders
in newborns in order to ensure rapid diagnosis and
followup.'';
(2) in subsection (d)--
(A) in paragraph (1)--
(i) by striking ``180'' and inserting ``120''; and
(ii) by adding at the end the following: ``If the Secretary
is unable to make a determination to adopt or reject such
recommendation within such 120-day period, the Secretary
shall notify the Advisory Committee and the appropriate
committees of Congress of such determination together with an
explanation for why the Secretary was unable to comply within
such 120-day period, as well as a plan of action for
consideration of such pending recommendation.'';
(B) by striking paragraph (2);
(C) by redesignating paragraph (3) as paragraph (2); and
(D) by adding at the end the following:
``(3) Deadline for review.--For each condition nominated to
be added to the recommended uniform screening panel in
accordance with the requirements of this section, the
Advisory Committee shall review and vote on the nominated
condition within 9 months of the date on which the Advisory
Committee referred the nominated condition to the condition
review workgroup.'';
(3) by redesignating subsections (f) and (g) as subsections
(g) and (h), respectively;
(4) by inserting after subsection (e) the following new
subsection:
``(f) Meetings.--The Advisory Committee shall meet at least
4 times each calendar year, or at the discretion of the
Designated Federal Officer in consultation with the Chair.'';
(5) by amending subsection (g) (as so redesignated) to read
as follows:
``(g) Continuation of Operation of Committee.--
``(1) In general.--Notwithstanding section 14 of the
Federal Advisory Committee Act, the Advisory Committee shall
continue to operate through the end of fiscal year 2019.
``(2) Continuation if not reauthorized.--If at the end of
fiscal year 2019 the duration of the Advisory Committee has
not been extended by statute, the Advisory Committee may be
deemed, for purposes of the Federal Advisory Committee Act,
an advisory committee established by the President or an
officer of the Federal Government under section 9(a) of such
Act.''; and
(6) by striking subsection (h) (relating to authorization
of appropriations), as redesignated by paragraph (3).
SEC. 5. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.
Section 1112 of the Public Health Service Act (42 U.S.C.
300b-11) is amended--
(1) in subsection (a)--
(A) in paragraph (2), by striking ``and'' at the end;
(B) in paragraph (3)--
(i) by striking ``data'' and inserting ``information''; and
(ii) by striking the period at the end and inserting a
semicolon; and
[[Page H5697]]
(C) by adding at the end the following new paragraphs:
``(4) maintain current information on the number of
conditions for which screening is conducted in each State;
and
``(5) disseminate available evidence-based guidelines
related to diagnosis, counseling, and treatment with respect
to conditions detected by newborn screening.'';
(2) in subsection (b)(4)(D), by striking ``Newborn
Screening Saves Lives Act of 2008'' and inserting ``Newborn
Screening Saves Lives Reauthorization Act of 2014'';
(3) in subsection (c)--
(A) by striking ``developing the clearinghouse'' and
inserting ``carrying out activities''; and
(B) by striking ``clearinghouse minimizes duplication and
supplements, not supplants'' and inserting ``activities
minimize duplication and supplement, not supplant''; and
(4) by striking subsection (d) (relating to authorization
of appropriations).
SEC. 6. LABORATORY QUALITY AND SURVEILLANCE.
Section 1113 of the Public Health Service Act (42 U.S.C.
300b-12) is amended--
(1) in the section heading, by inserting ``and
surveillance'' before the period;
(2) in subsection (a)--
(A) in the matter preceding paragraph (1), by striking
``and in consultation with the Advisory Committee'' and
inserting ``and taking into consideration the expertise of
the Advisory Committee''; and
(B) in paragraph (1), by inserting ``timeliness for
processing such tests,'' after ``newborn-screening tests,'';
and
(3) by striking subsection (b) (relating to authorization
of appropriations) and inserting the following:
``(b) Surveillance Activities.--The Secretary, acting
through the Director of the Centers for Disease Control and
Prevention, and taking into consideration the expertise of
the Advisory Committee on Heritable Disorders in Newborns and
Children established under section 1111, may provide, as
appropriate, for the coordination of surveillance activities,
including--
``(1) through standardized data collection and reporting,
as well as the use of electronic health records; and
``(2) by promoting data sharing regarding newborn screening
with State-based birth defects and developmental disabilities
monitoring programs.''.
SEC. 7. INTERAGENCY COORDINATING COMMITTEE ON NEWBORN AND
CHILD SCREENING.
Section 1114 of the Public Health Service Act (42 U.S.C.
300b-13) is amended--
(1) in subsection (c), by striking ``the Administrator, the
Director of the Agency for Healthcare Research and Quality,''
and inserting ``the Administrator of the Health Resources and
Services Administration, the Director of the Agency for
Healthcare Research and Quality, the Commissioner of Food and
Drugs,''; and
(2) by striking subsection (e) (relating to authorization
of appropriations).
SEC. 8. NATIONAL CONTINGENCY PLAN FOR NEWBORN SCREENING.
Section 1115(a) of the Public Health Service Act (42 U.S.C.
300b-14(a)) is amended--
(1) by striking ``consortia'' and inserting ``consortium'';
and
(2) by adding at the end the following: ``The plan shall be
updated as needed and at least every five years.''.
SEC. 9. 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) in subparagraph (B), by striking ``; and'' and
inserting a semicolon;
(B) by redesignating subparagraph (C) as subparagraph (E);
and
(C) by inserting after subparagraph (B) the following:
``(C) providing research findings and data for newborn
conditions under review by the Advisory Committee on
Heritable Disorders in Newborns and Children to be added to
the recommended uniform screening panel;
``(D) conducting pilot studies on conditions recommended by
the Advisory Committee on Heritable Disorders in Newborns and
Children to ensure that screenings are ready for nationwide
implementation; and''; and
(2) in subsection (c), by striking ``of the National
Institutes of Health Reform Act of 2006''.
SEC. 10. AUTHORIZATION OF APPROPRIATIONS.
Part A of title XI of the Public Health Service Act (42
U.S.C. 300b-1 et seq.) is amended by adding at the end, the
following:
``SEC. 1117. AUTHORIZATION OF APPROPRIATIONS FOR NEWBORN
SCREENING PROGRAMS AND ACTIVITIES.
``There are authorized to be appropriated--
``(1) to carry out sections 1109, 1110, 1111, and 1112,
$11,900,000 for each of fiscal years 2015 through 2019; and
``(2) to carry out section 1113, $8,000,000 for each of
fiscal years 2015 through 2019.''.
SEC. 11. REPORTS TO CONGRESS.
(a) GAO Report on Timeliness of Newborn Screening.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act, the Comptroller General of the United
States shall submit a report to the Committee on Health,
Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives concerning the timeliness of screening for
heritable disorders in newborns.
(2) Contents.--The report submitted under paragraph (1)
shall include the following:
(A) An analysis of information regarding the timeliness of
newborn screening, which may include the time elapsed from
birth to specimen collection, specimen collection to receipt
by laboratory, specimen receipt to reporting, reporting to
followup testing, and followup testing to confirmed
diagnosis.
(B) A summary of any guidelines, recommendations, or best
practices available to States and health care providers
intended to support a timely newborn screening system.
(C) An analysis of any barriers to maintaining a timely
newborn screening system which may exist and recommendations
for addressing such barriers.
(b) Report by Secretary.--
(1) In general.--The Secretary of Health and Human Services
shall--
(A) not later than 1 year after the date of enactment of
this Act, submit to the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives a report on
activities related to--
(i) newborn screening; and
(ii) screening children who have or are at risk for
heritable disorders; and
(B) not less than every 2 years, submit to such committees
an updated version of such report.
(2) Contents.--The report submitted under this subsection
shall contain a description of--
(A) the ongoing activities under sections 1109, 1110, and
1112 through 1115 of the Public Health Service Act; and
(B) the amounts expended on such activities.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Pennsylvania (Mr. Pitts) and the gentleman from Texas (Mr. Gene Green)
each will control 20 minutes.
The Chair recognizes the gentleman from Pennsylvania.
General Leave
Mr. PITTS. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days in which to revise and extend their remarks and
insert extraneous materials into the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Pennsylvania?
There was no objection.
Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume.
I rise today in support of H.R. 1281, the Newborn Screening Saves
Lives Reauthorization Act of 2014, introduced by Representative Lucille
Roybal-Allard of California and Representative Mike Simpson of Idaho,
which now includes 120 cosponsors.
This bill amends the Public Health Service Act to extend and revise a
grant program for screening, counseling, and other services related to
genetic disorders. H.R. 1281 reauthorizes Federal programs that provide
assistance to States to improve and expand their newborn screening
programs, support parent and provider education, and ensure laboratory
quality and surveillance.
Newborn screening is an important public health program for testing
every newborn for certain conditions not apparent at birth. This early
screening and diagnosis can be life changing for these children and
their families. I urge my colleagues to support this important
legislation.
I reserve the balance of my time.
Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself such time as I
may consume.
I rise in support of H.R. 1281, the Newborn Screening Saves Lives
Reauthorization Act of 2014.
Newborn screening is conducted for a number of genetic, metabolic,
hormonal, and functional conditions that may not be apparent at birth.
Approximately one in every 300 newborns has a condition that can be
detected through screening. If diagnosed early, many of these disorders
can be managed successfully.
H.R. 1281 reauthorizes the Department of Health and Human Services'
Advisory Committee that recommends conditions to be included in the
uniform screening panel; allows the Advisory Committee to begin the
consideration of certain new conditions more quickly; and requires the
Secretary of HHS to make determinations on the committee's
recommendations in a shorter period of time.
The bill also extends support for State programs involving screening,
counseling, education, and other services; demonstration programs to
evaluate the effectiveness of services; and a clearinghouse of
resources related to newborn screening.
This legislation puts a new emphasis on the timeliness of newborn
screening in all of these activities, and it requires the GAO to report
to Congress on this issue.
I want to thank the sponsors of this legislation, Congresswoman
Roybal-Allard and Congressman Simpson; the
[[Page H5698]]
sponsors of the Senate companion legislation, Senators Hagan and Hatch;
and the leaders on the Energy and Commerce Committee and on the Health,
Education, Labor, and Pensions Committee, for their work on this bill.
I support H.R. 1281, and I urge my colleagues to support the
legislation as well.
I reserve the balance of my time.
{time} 1900
Mr. PITTS. Mr. Speaker, I yield 1 minute to the distinguished
gentleman from New York (Mr. Collins).
Mr. COLLINS of New York. Mr. Speaker, I thank my colleague,
Representative Roybal-Allard, for her leadership on this important
issue.
I come to the House floor tonight to speak in support of H.R. 1281,
the Newborn Screening Saves Lives Reauthorization Act, which I am proud
to cosponsor.
For the last 50 years, newborn screening services have played an
important role for families across the country. Screening for
developmental disabilities or diseases at birth can identify treatable
diseases early and give a child the opportunity to live a healthy life.
I also want to take a moment to thank a leading advocate for newborn
screening, Buffalo Bills Hall of Fame Quarterback Jim Kelly, who is
from New York's 27th District.
In 1997, Jim and his wife, Jill, founded Hunter's Hope Foundation
shortly after their son Hunter was diagnosed with Krabbe disease.
Krabbe disease is fatal when left untreated and, tragically, cut
Hunter's life short.
With universal newborn screening, the story of Hunter Kelly and
countless others with developmental diseases could have been different.
I urge the House to reauthorize this vital program today.
Mr. GENE GREEN of Texas. Mr. Speaker, I yield as much time as she may
consume to my colleague from California (Ms. Roybal-Allard). We came in
at the same time in 1993.
Ms. ROYBAL-ALLARD. Mr. Speaker, I rise in support of the Newborn
Screening Saves Lives Reauthorization Act. I introduced this bill to
help ensure our babies continuing receiving lifesaving newborn
screenings.
I extend my sincere thanks to my lead cosponsor, Congressman Michael
Simpson, for his support and his long history of championing newborn
screening services.
I thank Senators Kay Hagan and Orrin Hatch for introducing the Senate
companion bill, which passed by unanimous consent in January of this
year.
I also thank the coalition of public health groups--especially the
March of Dimes and the Association of Public Health Laboratories--for
working with my office over the last 10 years on this critical issue.
Lastly, I would be remiss if I did not mention Debbie Jessup of my
staff, for her outstanding management of my bill, and the work of two
exceptional public health fellows, Arianna Baseman and Daphne Delgado,
who provided strong leadership in moving the bill forward.
Newborn screening is a public health intervention that involves
giving babies a simple blood test to identify many life-threatening
genetic and metabolic illnesses before symptoms begin. Newborn
screening is one of the great public health success stories of the 20th
century.
Prior to the enactment of the original Newborn Screening Saves Lives
Act in 2008, 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, 44 States and the District of Columbia require screening of at
least 29 of the 31 core treatable conditions. Today, professionals and
parents have centralized access to newborn screening information when
their baby is diagnosed with one of these disorders.
Since the passage of the original bill, newborn screenings have
improved, and new screenings have been added. These screenings are
critical for the approximately 12,000 babies who, each year, test
positive for one of these treatable diseases.
Fifty years ago, before newborn screening tests were developed, the
conditions of these babies would have gone undetected until symptoms
appeared. As a result, they would have unnecessarily died or suffered
from their lifelong disabling disorder.
Today, because of newborn screening, they have an opportunity and
they have hope for a relatively normal life.
The ability to rapidly identify and treat these disorders is making a
difference between health and disability--and even life or death--for
the children affected by these severe diseases. Unfortunately, critical
gaps and challenges still remain.
Due to existing discrepancies in the number of tests given from State
to State, each year, approximately 1,000 infants tragically die or are
permanently disabled from otherwise treatable disorders.
The passage of the Newborn Screening Saves Lives Reauthorization Act
will help avoid these preventable tragedies by providing States with
the resources they need to improve their newborn screening programs and
to uniformly test for all recommended disorders.
It also provides States with assistance in developing followup and
tracking programs. These provisions will help our financially burdened
health care system by saving billions of dollars over the life of these
children.
In addition, this bill renews the Secretary's Advisory Committee on
Heritable Disorders and requires the CDC to ensure the quality of
laboratories involved in newborn screening.
The bill also continues the Hunter Kelly Newborn Screening Program,
which helps NIH researchers develop better detection, prevention, and
treatment strategies.
Mr. Speaker, the Newborn Screening Saves Lives Reauthorization Act
will continue to help parents and health providers to be knowledgeable
about the importance of newborn screening tests, and it will help
ensure all our newborn babies receive the comprehensive and consistent
testing they need to have healthy, happy, and productive lives.
Where a baby is born should not determine its chance to have a
healthy future.
I urge my colleagues to vote ``yes'' on the passage of H.R. 1281.
Mr. PITTS. Mr. Speaker, I yield 3 minutes to the gentlewoman from
Minnesota (Mrs. Bachmann).
Mrs. BACHMANN. Mr. Speaker, I thank my colleague from Pennsylvania
(Mr. Pitts), one of the greatest champions that this Chamber has ever
seen in the cause of human life, and I share that cause with him as
well.
I thank the authors for their positive intentions on this bill. I am
a mother of five biological children and 23 foster children, and that
is what every parent and every mother and every father hopes, is to
have the best possible health care for their children, the best
possible outcome.
I do share concerns on this bill as well, as well intentioned as this
is, and let me just list what my concerns are.
Number one, the Federal Government will have the ability to collect
and automatically store the blood sample of every baby in the United
States. There won't be any allowance for parental consent to be
required before the storage of these blood samples are made.
Every baby's DNA, which is the entire genetic code of that baby, will
be under the control of the government.
I have data privacy concerns. Why should anyone, especially our
government, have everyone's identity at their disposal?
Third, there is no provision for any parent to opt out, so this
legislation presumes that every parent of every newborn in the United
States of America pre-agrees that the government can have their baby's
blood sample, which contains their DNA code, and that the government
can indefinitely store that data.
What limitations will there be on our government and what they can do
with this information and how they will handle this data?
Now, Mr. Speaker, knowing that our government has the potential to
control every American's health care under ObamaCare, how could
government's control of a baby's DNA information impact the full access
to health care or education opportunities or job opportunities for a
child who is predetermined, by their DNA, to potentially have a problem
later in life?
[[Page H5699]]
These are just a few of the questions, Mr. Speaker, that I believe
need to be addressed.
I know this bill has passed the Senate. I know it will be voice-
voted. I would like to ask for a rollcall vote, but I understand that
the process is already deep on its way.
I do hope that these questions will be addressed in future
legislation. It may not be done in this legislation. I hope it will be
in the future because we should not be--Americans should not see the
death of privacy, especially of the most sensitive private information
that every American can have, their DNA, their genetic code, what God
gave to them--that should be something that is between the individual,
their doctor, and God; and it shouldn't be for the government to
control that data.
I want to thank Mr. Pitts. I, in no way, cast any negative aspersion
upon himself or any of the authors on this bill. These are just some of
the questions that I have.
Mr. GENE GREEN of Texas. Mr. Speaker, I have no other speakers. I
urge support for the legislation and yield back the balance of my time.
Mr. PITTS. Mr. Speaker, I urge support, again, for this important and
bipartisan 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 Pennsylvania (Mr. Pitts) that the House suspend the
rules and pass the bill, H.R. 1281, 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.
____________________