Newborn Screening Saves Lives Reauthorization Act of 2019
This bill reauthorizes through FY2024 and revises several programs and activities relating to newborn screening for genetic diseases. Among other things, the bill reauthorizes, and makes mandatory rather than discretionary, the Hunter Kelly Research Program at the National Institutes of Health as well as national surveillance activities conducted by the Centers for Disease Control and Prevention.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2507 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
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.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 2, 2019
Ms. Roybal-Allard (for herself, Mr. Simpson, Ms. Clark of
Massachusetts, and Ms. Herrera Beutler) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
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.
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.
Section 1109(a)(3) of the Public Health Service Act (42 U.S.C.
300b-8(a)(3)) is amended to read as follows:
``(3) to develop and deliver educational programs (at
appropriate literacy levels) about newborn screening
counseling, testing, follow-up, treatment, specialty services,
and long-term care to parents, families, and patient advocacy
and support groups that assess the target audience's current
knowledge, incorporate health communications strategies, and
measure impact;''.
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 (7) by striking ``and'' at the
end;
(B) by redesignating paragraph (8) as paragraph
(9); and
(C) 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''; 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 evaluated 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--
``(1) shall ensure that entities receiving funding through
the program will provide assurances, as practicable, that such
entities will work in consultation with the appropriate State
departments of health; and
``(2) may accept, use, and dispose of donations and
bequests from private for-profit and non-profit entities, in
accordance with Federal law.''.
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 part 4 of
section 46.104 of title 45, Code of Federal 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.
(b) 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.
(c) Authorization of Appropriations.--There is authorized to be
appropriated $2,000,000 for the period of fiscal years 2020 and 2021 to
carry out this section.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
Sponsor introductory remarks on measure. (CR H3796)
Subcommittee Hearings Held.
Subcommittee Consideration and Mark-up Session Held.
Forwarded by Subcommittee to Full Committee (Amended) by Voice Vote .
Committee Consideration and Mark-up Session Held.
Ordered to be Reported (Amended) by Voice Vote.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-174.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-174.
Placed on the Union Calendar, Calendar No. 134.
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Mr. Pallone moved to suspend the rules and pass the bill, as amended.
Considered under suspension of the rules. (consideration: CR H7365-7368)
DEBATE - The House proceeded with forty minutes of debate on H.R. 2507.
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H7365-7367)
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H7365-7367)
Motion to reconsider laid on the table Agreed to without objection.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.