[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1858 Introduced in Senate (IS)]
110th CONGRESS
1st Session
S. 1858
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 SENATE OF THE UNITED STATES
July 23, 2007
Mr. Dodd (for himself, Mr. Hatch, Mrs. Clinton, and Mr. Kennedy)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
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
2007''.
SEC. 2. FINDINGS.
Congress finds the following:
(1) Each year more than 4,000,000 babies born in the United
States are screened by State and private laboratories to detect
some conditions that may threaten their long-term health.
(2) However, there is a lack of uniformity in the number of
conditions for which newborns are screened throughout the
United States. While a newborn may be screened and treated for
a debilitating condition in one State, in another State, the
condition may go undetected and result in permanent disability
or even death.
(3) Approximately 4,000 infants born each year are
diagnosed with these detectable and treatable disorders. If
diagnosed early, these conditions can be successfully managed
or treated to prevent severe and often lifelong health
consequences.
(4) In 2004, the American College of Medical Genetics
(ACMG) completed a report commissioned by the Department of
Health and Human Services which recommended that every baby
born in the United States be screened for 29 specific
disorders, including certain metabolic conditions and hearing
deficiencies.
(5) Currently only 11 States and the District of Columbia
require infants to be screened for all 29 of these recommended
disorders.
(6) Continuity, especially during a public health
emergency, plays a critical role in the screening, diagnosis,
referral, and treatment of these disorders. Currently there is
no national contingency plan for maintaining continuity of
newborn screening systems following a public health emergency.
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. 399Z-1. NEWBORN SCREENING.
``(a) Authorization of Grant Programs.--From funds appropriated
under subsection (h), the Secretary, acting through the Administrator
of the Health Resources and Services Administration (referred to in
this section as the `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--
``(1) education in newborn screening; and
``(2) training in--
``(A) relevant and new technologies in newborn
screening; and
``(B) 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
with respect to newborn screening; and
``(ii) take all necessary steps to minimize
the duplication of the resources and programs
described in clause (i) and ensure that funding
under this section will supplement, not
supplant, existing funding for such activities.
``(d) Coordination.--The Secretary shall take all necessary steps
to coordinate programs funded with grants received under this section
and to coordinate with existing newborn screening activities.
``(e) Use of Grant Funds.--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--
``(1) continuing medical education programs for health care
professionals and newborn screening laboratory personnel in
newborn screening;
``(2) education, technical assistance, and training on new
discoveries in newborn screening and the use of any related
technology;
``(3) 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;
``(4) models to communicate effectively with parents and
families about--
``(A) the process and benefits of newborn screening
and the meaning of screening results, including the
possibility of false positive findings;
``(B) how to use information gathered from newborn
screening;
``(C) the right of refusal of newborn screening, if
applicable; and
``(D) the potential need for followup care after
newborns are screened;
``(5) information and resources on coordinated systems of
followup care after newborns are screened;
``(6) 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;
``(7) information on additional newborn screening that may
not be required by the State, but that may be available from
other sources; and
``(8) other items to carry out the purpose described in
subsection (a)(1) as determined appropriate by the Secretary.
``(f) Reports to Congress.--
``(1) In general.--Subject to paragraph (2), the Secretary
shall submit to the relevant committees of Congress reports--
``(A) evaluating the effectiveness and the impact
of the grants awarded under this section--
``(i) in promoting newborn screening
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,
State, and local 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) other entities 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) $5,000,000 for fiscal year 2008; and
``(2) such sums as may be necessary for each of fiscal
years 2009 through 2012.''.
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
``$15,000,000 for fiscal year 2008 and such sums as may be
necessary for each of the fiscal years 2009 through 2012.''.
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 2008
and such sums as may be necessary for each of the fiscal years 2009
through 2012.''.
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) in paragraph (1), by inserting ``and grants
awarded under section 399Z-1'' before the semicolon;
(B) by redesignating paragraph (3) as paragraph
(6);
(C) in paragraph (2), by striking ``and'' after the
semicolon;
(D) by inserting after paragraph (2) the following:
``(3) make systematic evidence-based and peer-reviewed
recommendations that include 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, as appropriate, based on such
decision-matrix;
``(5) consider ways to ensure that States attain the
capacity to screen for the conditions described in paragraph
(3), and include in such consideration the results of grant
funding under section 1109; and'';
(E) in paragraph (6) (as so redesignated by
subparagraph (A)), by striking the period at the end
and inserting ``, which may include 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) implementation, monitoring, and evaluation of
newborn screening activities, including diagnosis,
screening, follow-up, and treatment activities;
``(C) diagnostic and other technology used in
screening;
``(D) the availability and reporting of testing for
conditions for which there is no existing treatment;
``(E) conditions not included in the recommended
uniform screening panel that are treatable with Food
and Drug Administration-approved products;
``(F) minimum standards and related policies and
procedures used by State newborn screening programs,
such as language and terminology used by State newborn
screening programs to include standardization of case
definitions and names of disorders for which newborn
screening tests are performed;
``(G) quality assurance, oversight, and evaluation
of State newborn screening programs, including ensuring
that tests and technologies used by each State meet
established standards for detecting and reporting
positive screening results;
``(H) public and provider awareness and education;
``(I) the cost and effectiveness of newborn
screening and medical evaluation systems and
intervention programs conducted by State-based
programs;
``(J) identification of the causes of, and risk
factors for heritable disorders; and
``(K) coordination of surveillance activities,
including standardized data collection and reporting,
harmonization of laboratory definitions for heritable
disorders and testing results, and confirmatory testing
and verification of positive results, in order to
assess and enhance monitoring of newborn diseases.'';
and
(2) in subsection (c)(2)--
(A) by redesignating subparagraphs (E), (F) and (G)
as subparagraphs (F), (H), and (I);
(B) by inserting after subparagraph (D) the
following:
``(E) the Commissioner of the Food and Drug
Administration;''; and
(C) by inserting after subparagraph (F), as so
redesignated, the following:
``(G) individuals with expertise in ethics who have
worked and published material in the area of newborn
screening;''; and
(3) 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 2007 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) Annual Report.--Not later than 2 years after the date of
enactment of the Newborn Screening Saves Lives Act of 2007, and each
fiscal year thereafter, the Advisory Committee shall--
``(1) publish a report on peer-reviewed newborn screening
guidelines in the United States;
``(2) submit such report to the appropriate committees of
Congress, the Secretary, and the State departments of health;
and
``(3) disseminate such report on as wide a basis as
practicable, including through posting on the internet
clearinghouse established under section 1112.
``(f) 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 2007.
``(g) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section--
``(1) $1,000,000 for fiscal year 2008; and
``(2) such sums as may be necessary for each of the fiscal
years 2009 through 2012.''.
SEC. 7. INFORMATION CLEARINGHOUSE.
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. CLEARINGHOUSE OF NEWBORN SCREENING INFORMATION.
``(a) In General.--The Secretary, acting through the Administrator
of the Health Resources and Services Administration (referred to in
this part as the `Administrator'), in consultation with the Director of
the Centers for Disease Control and Prevention and the Director of the
National Institutes of Health, shall establish and maintain a central
clearinghouse of current educational and family support and services
information, materials, resources, research, and data on newborn
screening to--
``(1) enable parents and family members of newborns, health
professionals, industry representatives, and other members of
the public to increase their awareness, knowledge, and
understanding of newborn screening;
``(2) increase awareness, knowledge, and understanding of
newborn diseases and screening services for individuals wanting
to have children and expectant families; and
``(3) develop and maintain current data on quality
indicators to measure performance of newborn screening, such as
false-positive rates and other quality indicators as determined
by the Advisory Committee under section 1111.
``(b) Internet Availability.--The Secretary, acting through the
Administrator, shall ensure that the clearinghouse described under
subsection (a)--
``(1) is available on the Internet;
``(2) includes an interactive forum;
``(3) is updated on a regular basis, but not less than
quarterly; and
``(4) provides--
``(A) links to Government-sponsored, non-profit,
and other Internet websites of laboratories as
determined appropriate by the Secretary that have
demonstrated expertise in newborn screening that supply
research-based information on newborn screening tests
currently available throughout the United States;
``(B) information about newborn conditions and
screening services available in each State from
laboratories certified under subpart 2 of part F of
title III, including information about supplemental
screening that is available but not required, in the
State where the infant is born;
``(C) current research on both treatable and not-
yet treatable conditions for which newborn screening
tests are available;
``(D) the availability of Federal funding for
newborn and child screening for heritable disorders
including grants authorized under the Newborn Screening
Saves Lives Act of 2007; and
``(E) other relevant information as determined
appropriate by the Secretary.
``(c) Nonduplication.--In developing the clearinghouse under this
section, the Secretary shall ensure that such clearinghouse minimizes
duplication and supplements, not supplants, existing information
sharing efforts.
``(d) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section--
``(1) $2,500,000 for fiscal year 2008; and
``(2) such sums as may be necessary for each of the fiscal
years 2009 through 2012.''.
SEC. 8. LABORATORY QUALITY AND SURVEILLANCE.
Part A of title XI of the Public Health Service Act (42 U.S.C.
300b-1 et seq.), as amended by section 7, is further amended by adding
at the end the following:
``SEC. 1113. 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 2008 and such sums as may be necessary for each of the
fiscal years 2009 through 2012.
``SEC. 1114. SURVEILLANCE PROGRAMS FOR HERITABLE DISORDERS SCREENING.
``(a) In General.--The Secretary, acting through an Interagency
Group consisting of the Director of the Agency for Healthcare Research
and Quality, the Director of the Centers for Disease Control and
Prevention, the Administrator, and the Director of the National
Institutes of Health, shall build upon existing activities and
infrastructure to 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 incidence and prevalence
of, as well as poor health outcomes resulting from, such
disorders;
``(2) to operate regional centers for the conduct of
applied epidemiological research on effective interventions for
such disorders for the prevention of poor health outcomes;
``(3) to provide information and education to the public on
effective interventions for the prevention of poor health
outcomes resulting from such disorders; and
``(4) to conduct research on and to promote the prevention
of poor health outcomes resulting from 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) Reports to Congress.--
``(1) In general.--Subject to paragraph (2), the Secretary
shall submit to the relevant committees of Congress reports--
``(A) containing information under paragraph (1)
that is specific to various racial, ethnic, and
socioeconomic groups;
``(B) containing 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;
``(C) describing the activities carried out under
this section;
``(D) containing information on the incidence and
prevalence of individuals living with heritable
disorders, information on the health status of
individuals with such disorders including the extent to
which such disorders have contributed to the incidence
and prevalence of infant mortality, information on any
health disparities experienced by such individuals, and
recommendations for improving the health and wellness
and quality of life of such individuals;
``(E) containing a summary of recommendations from
all heritable disorders research conferences sponsored
by the Centers for Disease Control and Prevention; and
``(F) containing any recommendations of the
Secretary regarding this section.
``(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.
``(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 2008 and such sums as may be necessary for each of the
fiscal years 2009 through 2012.''.
SEC. 9. GRANTS.
Part A of title XI of the Public Health Service Act (42 U.S.C.
300b-1 et seq.), as amended by section 8, is further amended by adding
at the end the following:
``SEC. 1115. GRANTS.
``(a) Authorization of Grant Program.--
``(1) In general.--From funds appropriated under subsection
(h), the Secretary, acting through the Administrator and in
consultation with the Advisory Committee, shall award grants to
eligible entities to--
``(A) enable such entities to develop and deliver
educational programs about newborn screening to
parents, families, and patient advocacy and support
groups, such educational materials accompanying such
educational programs to be provided at appropriate
literacy levels; and
``(B) enable such entities to establish, maintain,
and operate a system to assess and coordinate treatment
relating to congenital, genetic, and metabolic
disorders.
``(2) 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 paragraph (1).
``(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.--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) and ensure that funding
under this section will supplement, not
supplant, existing funding for such activities.
``(d) Coordination.--The Secretary shall take all necessary steps
to coordinate programs funded with grants received under this section
and to coordinate with existing newborn screening activities.
``(e) Use of Grant Funds.--
``(1) In general.--An eligible entity that receives a grant
under this section may use the grant funds--
``(A) for purposes of grants under subsection
(a)(1)(A), to develop and deliver to parents, families,
and patient advocacy and support groups, educational
programs about newborn screening that include
information on--
``(i) what newborn screening is and how it
is performed;
``(ii) who performs newborn screening;
``(iii) where newborn screening is
performed;
``(iv) the disorders for which the State
requires newborns to be screened;
``(v) different options for newborn
screening for disorders other than those
included by the State in the mandated newborn
screening program;
``(vi) the meaning of various screening
results, including the possibility of false
positive and false negative findings;
``(vii) the prevalence and risk of newborn
disorders, including the increased risk of
disorders that may stem from family history;
``(viii) coordinated systems of followup
care after newborns are screened; and
``(ix) other items to carry out the purpose
described in subsection (a)(1) as determined
appropriate by the Secretary; and
``(B) for purposes of grants under subsection
(a)(1)(B), to--
``(i) 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 appropriate subspecialists such
as in congenital, genetic, and metabolic
disorders;
``(ii) coordinate ongoing followup
treatment with individuals, families, primary
care physicians, and appropriate subspecialists
such as 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;
``(iii) ensure the seamless integration of
confirmatory testing, tertiary care medical
services, comprehensive genetic services
including genetic counseling, and information
about Food and Drug Administration-approved
treatments as well as access to developing
therapies by participation in approved clinical
trials involving the primary health care of the
infant;
``(iv) 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;
``(v) collect, analyze and report data on
the costs, benefits and effectiveness of such
tests; and
``(vi) 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 relevant 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,
State, and local 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
``(i) 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) 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) other entities with appropriate expertise in newborn
screening, as determined by the Secretary.
``(h) Authorization of Appropriations.--There is authorized to be
appropriated to carry out this section--
``(1) $10,000,000 for fiscal year 2008; and
``(2) such sums as may be necessary for each of fiscal
years 2009 through 2012.''.
SEC. 10. CONTINGENCY PLANNING.
Part A of title XI of the Public Health Service Act (42 U.S.C.
300b-1 et seq.), as amended by section 9, is further amended by adding
at the end the following:
``SEC. 1116. NATIONAL CONTINGENCY PLAN FOR NEWBORN SCREENING.
``(a) In General.--Not later than 180 days after the date of
enactment of this section, the Secretary, acting through the Director
of the Centers for Disease Control and Prevention and in consultation
with the Administrator and State departments of health (or related
agencies), shall develop a national contingency plan for newborn
screening for use by a State, region, or consortia of States in the
event of a public health emergency.
``(b) Contents.--The contingency plan developed under subsection
(a) shall include a plan for--
``(1) the collection and transport of specimens;
``(2) the shipment of specimens to State newborn screening
laboratories;
``(3) the processing of specimens;
``(4) the reporting of screening results to physicians and
families;
``(5) the diagnostic confirmation of positive screening
results;
``(6) ensuring the availability of treatment and management
resources;
``(7) educating families about newborn screening; and
``(8) carrying out other activities determined appropriate
by the Secretary.
``SEC. 1117. HUNTER KELLY RESEARCH PROGRAM.
``(a) Additional Newborn Screening Tests Grants.--
``(1) In general.--The Secretary, in conjunction with the
Director of the National Institutes of Health and taking into
consideration the recommendations of the Advisory Committee,
shall establish a research program (to be known as `Hunter
Kelly Newborn Screening Research Program') by expanding,
carrying out, and coordinating research in--
``(A) identifying, developing, and testing the most
promising new screening technologies, in order to
improve already existing screening tests, which may
include tests for Krabbe Disease and Insulin Dependent
Diabetes Mellitus, and Turner Syndrome, increase the
specificity of newborn screening, and expand the number
of conditions for which screening tests are available;
``(B) experimental treatments and disease
management strategies for additional newborn
conditions, and other genetic, metabolic, hormonal and/
or functional conditions that can be detected through
newborn screening for which treatment is not yet
available; and
``(C) other activities that would improve newborn
screening, as identified by the Director.
``(2) Additional newborn condition.--For purposes of this
subsection, the term `additional newborn condition' means any
condition that is not one of the core conditions designated by
the Advisory Committee.
``(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 the
appropriate State departments of health, and, as practicable, focus
their research on screening technology not currently performed in the
States in which the entities are located, and the conditions on the
uniform screening panel (or the standard test existing on the uniform
screening panel).
``(c) Monitoring and Results.--The Director shall--
``(1) monitor and report on the activities resulting from
any funding distributed under this section; and
``(2) on an annual basis--
``(A) publish and disseminate the results of such
monitoring on as wide a basis as is practicable, which
may include incorporation of these results in other
newborn screening reports and posting on the Internet
Clearinghouse established under section 1112;
``(B) submit to the relevant committees of Congress
the results of such evaluation, which may include
incorporation of such results in other newborn
screening reports being submitted to Congress.
``(d) Nonduplication.--In carrying out programs under this section,
the Secretary shall minimize duplication and supplement, not supplant,
existing efforts of the type carried out under this section.
``(e) Peer Review.--Nothing in this section shall be construed to
interfere with the scientific peer-review process at the National
Institutes of Health.
``(f) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section--
``(1) $7,000,000 for fiscal year 2008; and
``(2) such sums as may be necessary for fiscal years 2009
through 2012.''.
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