[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1858 Reported in Senate (RS)]
Calendar No. 522
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, Mr. Kennedy, Mr. Bond,
Mrs. Murray, Ms. Collins, Mr. Inouye, Ms. Cantwell, Mr. Sanders, Mr.
Johnson, Mr. Whitehouse, Mr. Brown, Mr. Durbin, Mr. Lugar, Mr. Cardin,
Mrs. Lincoln, Mr. Casey, Mr. Harkin, Ms. Mikulski, and Mr. Coleman)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
December 5, 2007
Reported by Mr. Kennedy, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Newborn Screening Saves
Lives Act of 2007''.</DELETED>
<DELETED>SEC. 2. FINDINGS.</DELETED>
<DELETED> Congress finds the following:</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (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.</DELETED>
<DELETED> (5) Currently only 11 States and the District of
Columbia require infants to be screened for all 29 of these
recommended disorders.</DELETED>
<DELETED> (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.</DELETED>
<DELETED>SEC. 3. AMENDMENT TO TITLE III OF THE PUBLIC HEALTH SERVICE
ACT.</DELETED>
<DELETED> 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:</DELETED>
<DELETED>``SEC. 399Z-1. NEWBORN SCREENING.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(1) education in newborn screening;
and</DELETED>
<DELETED> ``(2) training in--</DELETED>
<DELETED> ``(A) relevant and new technologies in
newborn screening; and</DELETED>
<DELETED> ``(B) congenital, genetic, and metabolic
disorders.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(c) Selection of Grant Recipients.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Approval factors.--</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(i) will use grant funds only
for the purposes specified in the approved
application and in accordance with the
requirements of this section; and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(B) Existing programs.--Prior to
awarding a grant under this section, the Secretary
shall--</DELETED>
<DELETED> ``(i) conduct an assessment of
existing educational resources and training
programs with respect to newborn screening;
and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(1) continuing medical education programs for
health care professionals and newborn screening laboratory
personnel in newborn screening;</DELETED>
<DELETED> ``(2) education, technical assistance, and
training on new discoveries in newborn screening and the use of
any related technology;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(4) models to communicate effectively with
parents and families about--</DELETED>
<DELETED> ``(A) the process and benefits of newborn
screening and the meaning of screening results,
including the possibility of false positive
findings;</DELETED>
<DELETED> ``(B) how to use information gathered from
newborn screening;</DELETED>
<DELETED> ``(C) the right of refusal of newborn
screening, if applicable; and</DELETED>
<DELETED> ``(D) the potential need for followup care
after newborns are screened;</DELETED>
<DELETED> ``(5) information and resources on coordinated
systems of followup care after newborns are screened;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(7) information on additional newborn screening
that may not be required by the State, but that may be
available from other sources; and</DELETED>
<DELETED> ``(8) other items to carry out the purpose
described in subsection (a)(1) as determined appropriate by the
Secretary.</DELETED>
<DELETED> ``(f) Reports to Congress.--</DELETED>
<DELETED> ``(1) In general.--Subject to paragraph (2), the
Secretary shall submit to the relevant committees of Congress
reports--</DELETED>
<DELETED> ``(A) evaluating the effectiveness and the
impact of the grants awarded under this section--
</DELETED>
<DELETED> ``(i) in promoting newborn
screening education, resources, and training
for health care professionals;</DELETED>
<DELETED> ``(ii) on the successful diagnosis
and treatment of congenital, genetic, and
metabolic disorders; and</DELETED>
<DELETED> ``(iii) on the continued
development of coordinated systems of followup
care after newborns are screened;</DELETED>
<DELETED> ``(B) describing and evaluating the
effectiveness of the activities carried out with grant
funds received under this section; and</DELETED>
<DELETED> ``(C) that include recommendations for
Federal, State, and local actions to support--
</DELETED>
<DELETED> ``(i) education and training in
newborn screening; and</DELETED>
<DELETED> ``(ii) followup care after
newborns are screened.</DELETED>
<DELETED> ``(2) Timing of reports.--The Secretary shall
submit--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(g) Definition of Eligible Entity.--In this section, the
term `eligible entity' means--</DELETED>
<DELETED> ``(1) a State or a political subdivision of a
State;</DELETED>
<DELETED> ``(2) a consortium of 2 or more States or
political subdivisions of States;</DELETED>
<DELETED> ``(3) a territory;</DELETED>
<DELETED> ``(4) an Indian tribe or a hospital or outpatient
health care facility of the Indian Health Service; or</DELETED>
<DELETED> ``(5) other entities with appropriate expertise in
newborn screening, as determined by the Secretary.</DELETED>
<DELETED> ``(h) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section--</DELETED>
<DELETED> ``(1) $5,000,000 for fiscal year 2008;
and</DELETED>
<DELETED> ``(2) such sums as may be necessary for each of
fiscal years 2009 through 2012.''.</DELETED>
<DELETED>SEC. 4. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE
DISORDERS.</DELETED>
<DELETED> Section 1109 of the Public Health Service Act (42 U.S.C.
300b-8) is amended--</DELETED>
<DELETED> (1) in subsection (c)(2)--</DELETED>
<DELETED> (A) in subparagraph (E), by striking
``and'' after the semicolon;</DELETED>
<DELETED> (B) by redesignating subparagraph (F) as
subparagraph (G); and</DELETED>
<DELETED> (C) by inserting after subparagraph (E)
the following:</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (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.''.</DELETED>
<DELETED>SEC. 5. EVALUATING THE EFFECTIVENESS OF NEWBORN- AND CHILD-
SCREENING PROGRAMS.</DELETED>
<DELETED> Section 1110 of the Public Health Service Act (42 U.S.C.
300b-9) is amended by adding at the end the following:</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED>SEC. 6. ADVISORY COMMITTEE ON HERITABLE DISORDERS IN NEWBORNS
AND CHILDREN.</DELETED>
<DELETED> Section 1111 of the Public Health Service Act (42 U.S.C.
300b-10) is amended--</DELETED>
<DELETED> (1) in subsection (b)--</DELETED>
<DELETED> (A) in paragraph (1), by inserting ``and
grants awarded under section 399Z-1'' before the
semicolon;</DELETED>
<DELETED> (B) by redesignating paragraph (3) as
paragraph (6);</DELETED>
<DELETED> (C) in paragraph (2), by striking ``and''
after the semicolon;</DELETED>
<DELETED> (D) by inserting after paragraph (2) the
following:</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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'';</DELETED>
<DELETED> (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--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(B) implementation, monitoring, and
evaluation of newborn screening activities, including
diagnosis, screening, follow-up, and treatment
activities;</DELETED>
<DELETED> ``(C) diagnostic and other technology used
in screening;</DELETED>
<DELETED> ``(D) the availability and reporting of
testing for conditions for which there is no existing
treatment;</DELETED>
<DELETED> ``(E) conditions not included in the
recommended uniform screening panel that are treatable
with Food and Drug Administration-approved
products;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(H) public and provider awareness and
education;</DELETED>
<DELETED> ``(I) the cost and effectiveness of
newborn screening and medical evaluation systems and
intervention programs conducted by State-based
programs;</DELETED>
<DELETED> ``(J) identification of the causes of, and
risk factors for heritable disorders; and</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> (2) in subsection (c)(2)--</DELETED>
<DELETED> (A) by redesignating subparagraphs (E),
(F) and (G) as subparagraphs (F), (H), and
(I);</DELETED>
<DELETED> (B) by inserting after subparagraph (D)
the following:</DELETED>
<DELETED> ``(E) the Commissioner of the Food and
Drug Administration;''; and</DELETED>
<DELETED> (C) by inserting after subparagraph (F),
as so redesignated, the following:</DELETED>
<DELETED> ``(G) individuals with expertise in ethics
who have worked and published material in the area of
newborn screening;''; and</DELETED>
<DELETED> (3) by adding at the end the following:</DELETED>
<DELETED> ``(d) Decision on Recommendations.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(1) publish a report on peer-reviewed newborn
screening guidelines in the United States;</DELETED>
<DELETED> ``(2) submit such report to the appropriate
committees of Congress, the Secretary, and the State
departments of health; and</DELETED>
<DELETED> ``(3) disseminate such report on as wide a basis
as practicable, including through posting on the internet
clearinghouse established under section 1112.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(g) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section--</DELETED>
<DELETED> ``(1) $1,000,000 for fiscal year 2008;
and</DELETED>
<DELETED> ``(2) such sums as may be necessary for each of
the fiscal years 2009 through 2012.''.</DELETED>
<DELETED>SEC. 7. INFORMATION CLEARINGHOUSE.</DELETED>
<DELETED> 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:</DELETED>
<DELETED>``SEC. 1112. CLEARINGHOUSE OF NEWBORN SCREENING
INFORMATION.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(2) increase awareness, knowledge, and
understanding of newborn diseases and screening services for
individuals wanting to have children and expectant families;
and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(b) Internet Availability.--The Secretary, acting
through the Administrator, shall ensure that the clearinghouse
described under subsection (a)--</DELETED>
<DELETED> ``(1) is available on the Internet;</DELETED>
<DELETED> ``(2) includes an interactive forum;</DELETED>
<DELETED> ``(3) is updated on a regular basis, but not less
than quarterly; and</DELETED>
<DELETED> ``(4) provides--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(C) current research on both treatable
and not-yet treatable conditions for which newborn
screening tests are available;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(E) other relevant information as
determined appropriate by the Secretary.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(d) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section--</DELETED>
<DELETED> ``(1) $2,500,000 for fiscal year 2008;
and</DELETED>
<DELETED> ``(2) such sums as may be necessary for each of
the fiscal years 2009 through 2012.''.</DELETED>
<DELETED>SEC. 8. LABORATORY QUALITY AND SURVEILLANCE.</DELETED>
<DELETED> 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:</DELETED>
<DELETED>``SEC. 1113. LABORATORY QUALITY.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(2) population-based pilot testing for new
screening tools for evaluating use on a mass scale.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED>``SEC. 1114. SURVEILLANCE PROGRAMS FOR HERITABLE DISORDERS
SCREENING.</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(3) to provide information and education to the
public on effective interventions for the prevention of poor
health outcomes resulting from such disorders; and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(b) Grants and Contracts.--</DELETED>
<DELETED> ``(1) In general.--In carrying out subsection (a),
the Secretary may make grants to and enter into contracts with
public and nonprofit private entities.</DELETED>
<DELETED> ``(2) Supplies and services in lieu of award
funds.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(c) Reports to Congress.--</DELETED>
<DELETED> ``(1) In general.--Subject to paragraph (2), the
Secretary shall submit to the relevant committees of Congress
reports--</DELETED>
<DELETED> ``(A) containing information under
paragraph (1) that is specific to various racial,
ethnic, and socioeconomic groups;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(C) describing the activities carried
out under this section;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(E) containing a summary of
recommendations from all heritable disorders research
conferences sponsored by the Centers for Disease
Control and Prevention; and</DELETED>
<DELETED> ``(F) containing any recommendations of
the Secretary regarding this section.</DELETED>
<DELETED> ``(2) Timing of reports.--The Secretary shall
submit--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(e) Coordination.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.''.</DELETED>
<DELETED>SEC. 9. GRANTS.</DELETED>
<DELETED> 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:</DELETED>
<DELETED>``SEC. 1115. GRANTS.</DELETED>
<DELETED> ``(a) Authorization of Grant Program.--</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(B) enable such entities to establish,
maintain, and operate a system to assess and coordinate
treatment relating to congenital, genetic, and
metabolic disorders.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(c) Selection of Grant Recipients.--</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(2) Approval factors.--</DELETED>
<DELETED> ``(A) Requirements.--An application
submitted under subsection (b) may not be approved by
the Secretary unless the application contains
assurances that the eligible entity--</DELETED>
<DELETED> ``(i) will use grant funds only
for the purposes specified in the approved
application and in accordance with the
requirements of this section; and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(B) Existing programs.--Prior to
awarding a grant under this section, the Secretary
shall--</DELETED>
<DELETED> ``(i) conduct an assessment of
existing educational resources and training
programs and coordinated systems of followup
care with respect to newborn screening;
and</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(e) Use of Grant Funds.--</DELETED>
<DELETED> ``(1) In general.--An eligible entity that
receives a grant under this section may use the grant funds--
</DELETED>
<DELETED> ``(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--</DELETED>
<DELETED> ``(i) what newborn screening is
and how it is performed;</DELETED>
<DELETED> ``(ii) who performs newborn
screening;</DELETED>
<DELETED> ``(iii) where newborn screening is
performed;</DELETED>
<DELETED> ``(iv) the disorders for which the
State requires newborns to be
screened;</DELETED>
<DELETED> ``(v) different options for
newborn screening for disorders other than
those included by the State in the mandated
newborn screening program;</DELETED>
<DELETED> ``(vi) the meaning of various
screening results, including the possibility of
false positive and false negative
findings;</DELETED>
<DELETED> ``(vii) the prevalence and risk of
newborn disorders, including the increased risk
of disorders that may stem from family
history;</DELETED>
<DELETED> ``(viii) coordinated systems of
followup care after newborns are screened;
and</DELETED>
<DELETED> ``(ix) other items to carry out
the purpose described in subsection (a)(1) as
determined appropriate by the Secretary;
and</DELETED>
<DELETED> ``(B) for purposes of grants under
subsection (a)(1)(B), to--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(v) collect, analyze and report
data on the costs, benefits and effectiveness
of such tests; and</DELETED>
<DELETED> ``(vi) carry out such other
activities as the Secretary may determine
necessary.</DELETED>
<DELETED> ``(f) Reports to Congress.--</DELETED>
<DELETED> ``(1) In general.--Subject to paragraph (2), the
Secretary shall submit to the relevant committees of Congress
reports--</DELETED>
<DELETED> ``(A) evaluating the effectiveness and the
impact of the grants awarded under this section--
</DELETED>
<DELETED> ``(i) in promoting newborn
screening--</DELETED>
<DELETED> ``(I) education and
resources for families; and</DELETED>
<DELETED> ``(II) education,
resources, and training for health care
professionals;</DELETED>
<DELETED> ``(ii) on the successful diagnosis
and treatment of congenital, genetic, and
metabolic disorders; and</DELETED>
<DELETED> ``(iii) on the continued
development of coordinated systems of followup
care after newborns are screened;</DELETED>
<DELETED> ``(B) describing and evaluating the
effectiveness of the activities carried out with grant
funds received under this section; and</DELETED>
<DELETED> ``(C) that include recommendations for
Federal, State, and local actions to support--
</DELETED>
<DELETED> ``(i) education and training in
newborn screening; and</DELETED>
<DELETED> ``(ii) followup care after
newborns are screened.</DELETED>
<DELETED> ``(2) Timing of reports.--The Secretary shall
submit--</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(g) Eligible Entity.--In this section, the term
`eligible entity' means--</DELETED>
<DELETED> ``(1) a State or a political subdivision of a
State;</DELETED>
<DELETED> ``(2) a consortium of 2 or more States or
political subdivisions of States;</DELETED>
<DELETED> ``(3) a territory;</DELETED>
<DELETED> ``(4) an Indian tribe or a hospital or outpatient
health care facility of the Indian Health Service; or</DELETED>
<DELETED> ``(5) other entities with appropriate expertise in
newborn screening, as determined by the Secretary.</DELETED>
<DELETED> ``(h) Authorization of Appropriations.--There is
authorized to be appropriated to carry out this section--</DELETED>
<DELETED> ``(1) $10,000,000 for fiscal year 2008;
and</DELETED>
<DELETED> ``(2) such sums as may be necessary for each of
fiscal years 2009 through 2012.''.</DELETED>
<DELETED>SEC. 10. CONTINGENCY PLANNING.</DELETED>
<DELETED> 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:</DELETED>
<DELETED>``SEC. 1116. NATIONAL CONTINGENCY PLAN FOR NEWBORN
SCREENING.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(b) Contents.--The contingency plan developed under
subsection (a) shall include a plan for--</DELETED>
<DELETED> ``(1) the collection and transport of
specimens;</DELETED>
<DELETED> ``(2) the shipment of specimens to State newborn
screening laboratories;</DELETED>
<DELETED> ``(3) the processing of specimens;</DELETED>
<DELETED> ``(4) the reporting of screening results to
physicians and families;</DELETED>
<DELETED> ``(5) the diagnostic confirmation of positive
screening results;</DELETED>
<DELETED> ``(6) ensuring the availability of treatment and
management resources;</DELETED>
<DELETED> ``(7) educating families about newborn screening;
and</DELETED>
<DELETED> ``(8) carrying out other activities determined
appropriate by the Secretary.</DELETED>
<DELETED>``SEC. 1117. HUNTER KELLY RESEARCH PROGRAM.</DELETED>
<DELETED> ``(a) Additional Newborn Screening Tests Grants.--
</DELETED>
<DELETED> ``(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--
</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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</DELETED>
<DELETED> ``(C) other activities that would improve
newborn screening, as identified by the
Director.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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).</DELETED>
<DELETED> ``(c) Monitoring and Results.--The Director shall--
</DELETED>
<DELETED> ``(1) monitor and report on the activities
resulting from any funding distributed under this section;
and</DELETED>
<DELETED> ``(2) on an annual basis--</DELETED>
<DELETED> ``(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;</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(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.</DELETED>
<DELETED> ``(e) Peer Review.--Nothing in this section shall be
construed to interfere with the scientific peer-review process at the
National Institutes of Health.</DELETED>
<DELETED> ``(f) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section--</DELETED>
<DELETED> ``(1) $7,000,000 for fiscal year 2008;
and</DELETED>
<DELETED> ``(2) such sums as may be necessary for fiscal
years 2009 through 2012.''.</DELETED>
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Newborn Screening Saves Lives Act of
2007''.
SEC. 2. IMPROVED NEWBORN AND CHILD SCREENING FOR HERITABLE DISORDER.
Section 1109 of the Public Health Service Act (42 U.S.C. 300b-8) is
amended--
(1) by striking subsections (a), (b), and (c) and inserting
the following:
``(a) Authorization of Grant Program.--From amounts appropriated
under subsection (j), 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--
``(1) to enhance, improve or expand the ability of State
and local public health agencies to provide screening,
counseling, or health care services to newborns and children
having or at risk for heritable disorders;
``(2) to assist in providing health care professionals and
newborn screening laboratory personnel with education in
newborn screening and training in relevant and new technologies
in newborn screening and congenital, genetic, and metabolic
disorders;
``(3) to develop and deliver educational programs (at
appropriate literacy levels) about newborn screening
counseling, testing, follow-up, treatment, and specialty
services to parents, families, and patient advocacy and support
groups; and
``(4) to establish, maintain, and operate a system to
assess and coordinate treatment relating to congenital,
genetic, and metabolic disorders
``(b) 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) a health facility or program operated by or pursuant
to a contract with or grant from the Indian Health Service; or
``(5) any other entity with appropriate expertise in
newborn screening, as determined by the Secretary.
``(c) Approval Factors.--An application submitted for a grant under
subsection (a)(1) shall not be approved by the Secretary unless the
application contains assurances that the eligible entity has adopted
and implemented, is in the process of adopting and implementing, or
will use amounts received under such grant to adopt and implement the
guidelines and recommendations of 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.'';
(2) by redesignating subsections (d) through (i) as
subsections (e) through (j), respectively;
(3) by inserting after subsection (c), the following:
``(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.''; and
(4) by striking subsection (j) (as so redesignated) and
inserting the following:
``(j) Authorization of Appropriations.--There is authorized to be
appropriated--
``(1) to provide grants for the purpose of carrying
activities under section (a)(1), $15,000,000 for fiscal year
2008; $15,187,500 for fiscal year 2009, $15,375,000 for fiscal
year 2010, $15,562,500 for fiscal year 2011, and $15,750,000
for fiscal year 2012; and
``(2) to provide grant for the purpose of carrying out
activities under paragraphs (2), (3), and (4) of subsection
(a), $15,000,000 for fiscal year 2008, $15,187,500 for fiscal
year 2009, $15,375,000 for fiscal year 2010, $15,562,500 for
fiscal year 2011, and $15,750,000 for fiscal year 2012.''.
SEC. 3. 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,
$5,062,500 for fiscal year 2009, $5,125,000 for fiscal year 2010,
$5,187,500 for fiscal year 2011, and $5,250,000 for fiscal year
2012.''.
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 paragraph (3) as paragraph
(6);
(B) in paragraph (2), by striking ``and'' after the
semicolon;
(C) by inserting after paragraph (2) the following:
``(3) make systematic evidence-based and peer-reviewed
recommendations that include the heritable disorders that have
the potential to significantly impact public health 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
expansion, including an evaluation of the potential public
health impact of such expansion, and periodically update the
recommended uniform screening panel, as appropriate, based on
such decision-matrix;
``(5) consider ways to ensure that all 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) follow-up 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 or other safe
and effective treatments, as determined by scientific
evidence and peer review;
``(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, public
health impacts 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 and
infectious diseases 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 3 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, including follow-up and treatment, 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, $1,000,000 for fiscal year
2008, $1,012,500 for fiscal year 2009, $1,025,000 for fiscal year 2010,
$1,037,500 for fiscal year 2011, and $1,050,000 for fiscal year
2012.''.
SEC. 5. 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 expectant
individuals and families; and
``(3) 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 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, $2,500,000 for fiscal year
2008, $2,531,250 for fiscal year 2009, $2,562,500 for fiscal year 2010,
$2,593,750 for fiscal year 2011, and $2,625,000 for fiscal year
2012.''.
SEC. 6. 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 5, 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) appropriate quality control and other performance
test materials to evaluate the performance of new screening
tools.
``(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, $5,062,500 for fiscal year 2009, $5,125,000 for
fiscal year 2010, $5,187,500 for fiscal year 2011, and $5,250,000 for
fiscal year 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 identify 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 or
the National Institutes of Health; 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) 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.
``(e) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $15,000,000
for fiscal year 2008, $15,187,500 for fiscal year 2009, $15,375,000 for
fiscal year 2010, $15,562,500 for fiscal year 2011, and $15,750,000 for
fiscal year 2012.''.
SEC. 7. 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 6, is further amended by adding
at the end the following:
``SEC. 1115. 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. 1116. HUNTER KELLY RESEARCH PROGRAM.
``(a) Newborn Screening Activities.--
``(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,
may continue carrying out, coordinating, and expanding research
in newborn screening (to be known as `Hunter Kelly Newborn
Screening Research Program') including--
``(A) identifying, developing, and testing the most
promising new screening technologies, in order to
improve already existing screening tests, 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 recommended by
the Advisory Committee and adopted by the Secretary.
``(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) Reports.--The Director is encouraged to include information
about the activities carried out under this section in the biennial
report required under section 403 of the National Institutes of Health
Reform Act of 2006. If such information is included, the Director shall
make such information available to be included on the Internet
Clearinghouse established under section 1112.
``(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.''.
Calendar No. 522
110th CONGRESS
1st Session
S. 1858
_______________________________________________________________________
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.
_______________________________________________________________________
December 5, 2007
Reported with an amendment