[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5397 Introduced in House (IH)]
109th CONGRESS
2d Session
H. R. 5397
To amend the Public Health Service Act to establish grant programs to
provide for education and outreach on newborn screening and coordinated
followup care once newborn screening has been conducted, to reauthorize
programs under part A of title XI of such Act, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 16, 2006
Ms. Roybal-Allard (for herself and Mr. Simpson) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to establish grant programs to
provide for education and outreach on newborn screening and coordinated
followup care once newborn screening has been conducted, to reauthorize
programs under part A of title XI of such Act, 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 Act of
2006''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Currently, it is possible to test for more than 30
disorders through newborn screening.
(2) There is a lack of uniform newborn screening throughout
the United States. While a newborn with a debilitating
condition may receive screening, early detection, and treatment
in 1 location, in another location the condition may go
undetected and result in catastrophic consequences.
(3) Each year more than 4,000,000 babies are screened by
State and private laboratories to detect conditions that may
threaten their long-term health.
(4) There are more than 2,000 babies born every year in the
United States with detectable and treatable disorders that go
unscreened through newborn screening.
SEC. 3. AMENDMENT TO TITLE III OF THE PUBLIC HEALTH SERVICE ACT.
Part Q of title III of the Public Health Service Act (42 U.S.C.
280h et seq.) is amended by adding at the end the following:
``SEC. 399AA. NEWBORN SCREENING.
``(a) Authorization of Grant Programs.--
``(1) Grants to assist health care professionals.--From
funds appropriated under subsection (h), the Secretary, acting
through the Associate Administrator of the Maternal and Child
Health Bureau of the Health Resources and Services
Administration (referred to in this section as the `Associate
Administrator') and in consultation with the Advisory Committee
on Heritable Disorders in Newborns and Children (referred to in
this section as the `Advisory Committee'), shall award grants
to eligible entities to enable such entities to assist in
providing health care professionals and newborn screening
laboratory personnel with--
``(A) education in newborn screening; and
``(B) training in--
``(i) relevant and new technologies in
newborn screening; and
``(ii) congenital, genetic, and metabolic
disorders.
``(2) Grants to assist families.--
``(A) In general.--From funds appropriated under
subsection (h), the Secretary, acting through the
Associate Administrator and in consultation with the
Advisory Committee, shall award grants to eligible
entities to enable such entities to develop and deliver
educational programs about newborn screening to
parents, families, and patient advocacy and support
groups. The educational materials accompanying such
educational programs shall be provided at appropriate
literacy levels.
``(B) Awareness of the availability of programs.--
To the extent practicable, the Secretary shall make
relevant health care providers aware of the
availability of the educational programs supported
pursuant to subparagraph (A).
``(3) Grants for quality newborn screening followup.--From
funds appropriated under subsection (h), the Secretary, acting
through the Associate Administrator and in consultation with
the Advisory Committee, shall award grants to eligible entities
to enable such entities to establish, maintain, and operate a
system to assess and coordinate treatment relating to
congenital, genetic, and metabolic disorders.
``(b) Application.--An eligible entity that desires to receive a
grant under this section shall submit an application to the Secretary
at such time, in such manner, and accompanied by such information as
the Secretary may require.
``(c) Selection of Grant Recipients.--
``(1) In general.--Not later than 120 days after receiving
an application under subsection (b), the Secretary, after
considering the approval factors under paragraph (2), shall
determine whether to award the eligible entity a grant under
this section.
``(2) Approval factors.--
``(A) Requirements for approval.--An application
submitted under subsection (b) may not be approved by
the Secretary unless the application contains
assurances that the eligible entity--
``(i) will use grant funds only for the
purposes specified in the approved application
and in accordance with the requirements of this
section; and
``(ii) will establish such fiscal control
and fund accounting procedures as may be
necessary to assure proper disbursement and
accounting of Federal funds paid to the
eligible entity under the grant.
``(B) Existing programs.--Prior to awarding a grant
under this section, the Secretary shall--
``(i) conduct an assessment of existing
educational resources and training programs and
coordinated systems of followup care with
respect to newborn screening; and
``(ii) take all necessary steps to minimize
the duplication of the resources and programs
described in clause (i).
``(d) Coordination.--The Secretary shall take all necessary steps
to coordinate programs funded with grants received under this section.
``(e) Use of Grant Funds.--
``(1) Grants to assist health care professionals.--An
eligible entity that receives a grant under subsection (a)(1)
may use the grant funds to work with appropriate medical
schools, nursing schools, schools of public health, schools of
genetic counseling, internal education programs in State
agencies, nongovernmental organizations, and professional
organizations and societies to develop and deliver education
and training programs that include--
``(A) continuing medical education programs for
health care professionals and newborn screening
laboratory personnel in newborn screening;
``(B) education, technical assistance, and training
on new discoveries in newborn screening and the use of
any related technology;
``(C) models to evaluate the prevalence of, and
assess and communicate the risks of, congenital
conditions, including the prevalence and risk of some
of these conditions based on family history;
``(D) models to communicate effectively with
parents and families about--
``(i) the process and benefits of newborn
screening;
``(ii) how to use information gathered from
newborn screening;
``(iii) the meaning of screening results,
including the possibility of false positive
findings;
``(iv) the right of refusal of newborn
screening, if applicable; and
``(v) the potential need for followup care
after newborns are screened;
``(E) information and resources on coordinated
systems of followup care after newborns are screened;
``(F) information on the disorders for which States
require and offer newborn screening and options for
newborn screening relating to conditions in addition to
such disorders;
``(G) information on additional newborn screening
that may not be required by the State, but that may be
available from other sources; and
``(H) other items to carry out the purpose
described in subsection (a)(1) as determined
appropriate by the Secretary.
``(2) Grants to assist families.--An eligible entity that
receives a grant under subsection (a)(2) may use the grant
funds to develop and deliver to parents, families, and patient
advocacy and support groups, educational programs about newborn
screening that include information on--
``(A) what newborn screening is;
``(B) how newborn screening is performed;
``(C) who performs newborn screening;
``(D) where newborn screening is performed;
``(E) the disorders for which the State requires
newborns to be screened;
``(F) different options for newborn screening for
disorders other than those included by the State in the
mandated newborn screening program;
``(G) the meaning of various screening results,
including the possibility of false positive and false
negative findings;
``(H) the prevalence and risk of newborn disorders,
including the increased risk of disorders that may stem
from family history;
``(I) coordinated systems of followup care after
newborns are screened; and
``(J) other items to carry out the purpose
described in subsection (a)(2) as determined
appropriate by the Secretary.
``(3) Grants for quality newborn screening followup.--An
eligible entity that receives a grant under subsection (a)(3)
shall use the grant funds to--
``(A) expand on existing procedures and systems,
where appropriate and available, for the timely
reporting of newborn screening results to individuals,
families, primary care physicians, and subspecialists
in congenital, genetic, and metabolic disorders;
``(B) coordinate ongoing followup treatment with
individuals, families, primary care physicians, and
subspecialists in congenital, genetic, and metabolic
disorders after a newborn receives an indication of the
presence or increased risk of a disorder on a screening
test;
``(C) ensure the seamless integration of
confirmatory testing, tertiary care medical services,
comprehensive genetic services including genetic
counseling, and information about access to developing
therapies by participation in approved clinical trials
involving the primary health care of the infant;
``(D) analyze data, if appropriate and available,
collected from newborn screenings to identify
populations at risk for disorders affecting newborns,
examine and respond to health concerns, recognize and
address relevant environmental, behavioral,
socioeconomic, demographic, and other relevant risk
factors; and
``(E) carry out such other activities as the
Secretary may determine necessary.
``(f) Reports to Congress.--
``(1) In general.--Subject to paragraph (2), the Secretary
shall submit to the appropriate committees of Congress
reports--
``(A) evaluating the effectiveness and the impact
of the grants awarded under this section--
``(i) in promoting newborn screening--
``(I) education and resources for
families; and
``(II) education, resources, and
training for health care professionals;
``(ii) on the successful diagnosis and
treatment of congenital, genetic, and metabolic
disorders; and
``(iii) on the continued development of
coordinated systems of followup care after
newborns are screened;
``(B) describing and evaluating the effectiveness
of the activities carried out with grant funds received
under this section; and
``(C) that include recommendations for Federal
actions to support--
``(i) education and training in newborn
screening; and
``(ii) followup care after newborns are
screened.
``(2) Timing of reports.--The Secretary shall submit--
``(A) an interim report that includes the
information described in paragraph (1), not later than
30 months after the date on which the first grant funds
are awarded under this section; and
``(B) a subsequent report that includes the
information described in paragraph (1), not later than
60 months after the date on which the first grant funds
are awarded under this section.
``(g) Definition of Eligible Entity.--In this section, the term
`eligible entity' means--
``(1) a State or a political subdivision of a State;
``(2) a consortium of 2 or more States or political
subdivisions of States;
``(3) a territory;
``(4) an Indian tribe or a hospital or outpatient health
care facility of the Indian Health Service; or
``(5) a nongovernmental organization with appropriate
expertise in newborn screening, as determined by the Secretary.
``(h) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section--
``(1) $15,000,000 for fiscal year 2007; and
``(2) such sums as may be necessary for each of fiscal
years 2008 through 2011.''.
SEC. 4. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE DISORDERS.
Section 1109 of the Public Health Service Act (42 U.S.C. 300b-8) is
amended--
(1) in subsection (c)(2)--
(A) in subparagraph (E), by striking ``and'' after
the semicolon;
(B) by redesignating subparagraph (F) as
subparagraph (G); and
(C) by inserting after subparagraph (E) the
following:
``(F) an assurance that the entity has adopted and
implemented, is in the process of adopting and
implementing, or will use grant amounts received under
this section to adopt and implement the guidelines and
recommendations of the Advisory Committee on Heritable
Disorders in Newborns and Children established under
section 1111 (referred to in this section as the
`Advisory Committee') that are adopted by the Secretary
and in effect at the time the grant is awarded or
renewed under this section, which shall include the
screening of each newborn for the heritable disorders
recommended by the Advisory Committee and adopted by
the Secretary and the reporting of results; and''; and
(2) in subsection (i), by striking ``such sums'' and all
that follows through the period at the end and inserting
``$25,000,000 for fiscal year 2007 and such sums as may be
necessary for each of the fiscal years 2008 through 2011.''.
SEC. 5. EVALUATING THE EFFECTIVENESS OF NEWBORN- AND CHILD-SCREENING
PROGRAMS.
Section 1110 of the Public Health Service Act (42 U.S.C. 300b-9) is
amended by adding at the end the following:
``(d) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section $5,000,000 for fiscal year 2007
and such sums as may be necessary for each of the fiscal years 2008
through 2011.''.
SEC. 6. 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 paragraph (3) as paragraph
(5);
(B) in paragraph (2), by striking ``and'' after the
semicolon;
(C) by inserting after paragraph (2) the following:
``(3) recommend a uniform screening panel for newborn
screening programs that includes the heritable disorders for
which all newborns should be screened, including secondary
conditions that may be identified as a result of the laboratory
methods used for screening;
``(4) develop a model decision-matrix for newborn screening
program expansion, and periodically update the recommended
uniform screening panel described in paragraph (3) based on
such decision-matrix; and''; and
(D) in paragraph (5) (as redesignated by
subparagraph (A)), by striking the period at the end
and inserting ``, including recommendations, advice, or
information dealing with--
``(A) followup activities, including those
necessary to achieve rapid diagnosis in the short term,
and those that ascertain long-term case management
outcomes and appropriate access to related services;
``(B) diagnostic and other technology used in
screening;
``(C) the availability and reporting of testing for
conditions for which there is no existing treatment;
``(D) minimum standards and related policies and
procedures for State newborn screening programs;
``(E) quality assurance, oversight, and evaluation
of State newborn screening programs;
``(F) data collection for assessment of newborn
screening programs;
``(G) public and provider awareness and education;
``(H) language and terminology used by State
newborn screening programs;
``(I) confirmatory testing and verification of
positive results; and
``(J) harmonization of laboratory definitions for
results that are within the expected range and results
that are outside of the expected range.''; and
(2) by adding at the end the following:
``(d) Decision on Recommendations.--
``(1) In general.--Not later than 180 days after the
Advisory Committee issues a recommendation pursuant to this
section, the Secretary shall adopt or reject such
recommendation.
``(2) Pending recommendations.--The Secretary shall adopt
or reject any recommendation issued by the Advisory Committee
that is pending on the date of enactment of the Newborn
Screening Saves Lives Act of 2006 by not later than 180 days
after the date of enactment of such Act.
``(3) Determinations to be made public.--The Secretary
shall publicize any determination on adopting or rejecting a
recommendation of the Advisory Committee pursuant to this
subsection, including the justification for the determination.
``(e) Continuation of Operation of Committee.--Notwithstanding
section 14 of the Federal Advisory Committee Act (5 U.S.C. App.), the
Advisory Committee shall continue to operate during the 5-year period
beginning on the date of enactment of the Newborn Screening Saves Lives
Act of 2006.''.
SEC. 7. LABORATORY QUALITY AND SURVEILLANCE.
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. 1112. LABORATORY QUALITY.
``(a) In General.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention and in consultation with
the Advisory Committee on Heritable Disorders in Newborns and Children
established under section 1111, shall provide for--
``(1) quality assurance for laboratories involved in
screening newborns and children for heritable disorders,
including quality assurance for newborn-screening tests,
performance evaluation services, and technical assistance and
technology transfer to newborn screening laboratories to ensure
analytic validity and utility of screening tests; and
``(2) population-based pilot testing for new screening
tools for evaluating use on a mass scale.
``(b) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $5,000,000
for fiscal year 2007 and such sums as may be necessary for each of the
fiscal years 2008 through 2011.
``SEC. 1113. SURVEILLANCE PROGRAMS FOR HERITABLE DISORDERS SCREENING.
``(a) In General.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, shall carry out
programs--
``(1) to collect, analyze, and make available data on the
heritable disorders recommended by the Advisory Committee on
Heritable Disorders in Newborns and Children established under
section 1111, including data on the causes of such disorders
and on the incidence and prevalence of such disorders;
``(2) to operate regional centers for the conduct of
applied epidemiological research on the prevention of such
disorders;
``(3) to provide information and education to the public on
the prevention of such disorders; and
``(4) to conduct research on and to promote the prevention
of such disorders, and secondary health conditions among
individuals with such disorders.
``(b) Grants and Contracts.--
``(1) In general.--In carrying out subsection (a), the
Secretary may make grants to and enter into contracts with
public and nonprofit private entities.
``(2) Supplies and services in lieu of award funds.--
``(A) In general.--Upon the request of a recipient
of an award of a grant or contract under paragraph (1),
the Secretary may, subject to subparagraph (B), provide
supplies, equipment, and services for the purpose of
aiding the recipient in carrying out the purposes for
which the award is made and, for such purposes, may
detail to the recipient any officer or employee of the
Department of Health and Human Services.
``(B) Reduction.--With respect to a request
described in subparagraph (A), the Secretary shall
reduce the amount of payments under the award involved
by an amount equal to the costs of detailing personnel
and the fair market value of any supplies, equipment,
or services provided by the Secretary. The Secretary
shall, for the payment of expenses incurred in
complying with such request, expend the amounts
withheld.
``(3) Application for award.--The Secretary may make an
award of a grant or contract under paragraph (1) only if an
application for the award is submitted to the Secretary and the
application is in such form, is made in such manner, and
contains such agreements, assurances, and information as the
Secretary determines to be necessary to carry out the purposes
for which the award is to be made.
``(c) Biennial Report.--Not later than February 1 of fiscal year
2007 and of every second such year thereafter, the Secretary shall
submit to the Committee on Energy and Commerce of the House of
Representatives, and the Committee on Health, Education, Labor, and
Pensions of the Senate, a report that, with respect to the preceding 2
fiscal years--
``(1) contains information regarding the incidence and
prevalence of heritable disorders and the health status of
individuals with such disorders and the extent to which such
disorders have contributed to the incidence and prevalence of
infant mortality and affected quality of life;
``(2) contains information under paragraph (1) that is
specific to various racial and ethnic groups (including
Hispanics, non-Hispanic whites, Blacks, Native Americans, and
Asian Americans);
``(3) contains an assessment of the extent to which various
approaches of preventing heritable disorders and secondary
health conditions among individuals with such disorders have
been effective;
``(4) describes the activities carried out under this
section;
``(5) contains information on the incidence and prevalence
of individuals living with heritable disorders, information on
the health status of individuals with such disorders,
information on any health disparities experienced by such
individuals, and recommendations for improving the health and
wellness and quality of life of such individuals;
``(6) contains a summary of recommendations from all
heritable disorders research conferences sponsored by the
Centers for Disease Control and Prevention; and
``(7) contains any recommendations of the Secretary
regarding this section.
``(d) Applicability of Privacy Laws.--The provisions of this
section shall be subject to the requirements of section 552a of title
5, United States Code. All Federal laws relating to the privacy of
information shall apply to the data and information that is collected
under this section.
``(e) Coordination.--
``(1) In general.--In carrying out this section, the
Secretary shall coordinate, to the extent practicable, programs
under this section with programs on birth defects and
developmental disabilities authorized under section 317C.
``(2) Priority in grants and contracts.--In making grants
and contracts under this section, the Secretary shall give
priority to entities that demonstrate the ability to coordinate
activities under a grant or contract made under this section
with existing birth defects surveillance activities.
``(f) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $15,000,000
for fiscal year 2007 and such sums as may be necessary for each of the
fiscal years 2008 through 2011.''.
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