[Congressional Record Volume 153, Number 29 (Thursday, February 15, 2007)]
[Senate]
[Pages S2082-S2085]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DODD (for himself and Mr. Hatch):
  S. 634. 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; to the Committee on Health, Education, 
Labor, and Pensions.
  Mr. DODD. Mr. President, I am pleased today to join with my colleague 
Senator Hatch to introduce legislation to protect the most vulnerable 
members of our society: newborn infants. Many people know the joy of 
parenthood. These parents know the sense of worry about whether their 
kids are doing well, are feeling well, and are safe. Nothing is of 
greater importance than the health and well-being of our children.
  Thanks to incredible advances in medical technology, it is now 
possible to test newborns for more than 50 genetic and metabolic 
disorders. Many of these disorders, if undetected, would lead to severe 
disability or death. However, babies that are properly diagnosed and 
treated can, in many cases, go on to live healthy lives. So newborn 
screening can literally save lives.
  Frighteningly, the disorders that newborn screening tests for can 
come without warning. For most of these disorders, there is no medical 
history of the condition in the family and no way to predict the health 
of a baby based on the health of the parents. Although the disorders 
that are tested for are quite rare, there is a chance that any one 
newborn will be affected. In that sense, this is an issue that has a 
direct impact on the lives of all families.
  Fortunately, some screening has become common practice in every 
state. Each year, over four million infants have blood taken from their 
heel after birth to detect these disorders that could threaten their 
life and long-term health. As a result, about one in 4,000 babies is 
diagnosed with one of these disorders. That means that newborn 
screening could protect the health or save the life of approximately 
1,000 newborns each year. That is 1,000 tragedies that can be averted 
families that can know the joy of a new infant rather than absolute 
heartbreak.
  In 2004, the American College of Medical Genetics (ACMG) completed a 
report commissioned by the U.S. Department of Health and Human Services 
which recommended that every baby born in the U.S. be screened for 
twenty-nine disorders, including certain metabolic conditions and 
hearing deficiency. Unfortunately, as of February 2007, only 11 States 
and the District of Columbia require infants to be screened for all 
twenty-nine of these recommended disorders. If diagnosed early, all of 
these conditions can be successfully managed or treated to prevent or 
mitigate severe and often lifelong health problems.
  For every baby saved, another two are estimated to be born with 
potentially detectable disorders that go undetected because they are 
not screened. These infants and their families face the prospect of 
disability or death from a preventable disorder. The survival of a 
newborn may very well come down to the state in which it is born, 
because not all states test for every detectable disorder.
  The Government Accountability Office, GAO, released a report in 2003 
highlighting the need for this legislation. According to the report, 
most states do not educate parents and health care providers about the 
availability of tests beyond what is mandated by a State. States also 
reported that they do not have the resources to purchase the technology 
and train the staff needed to expand newborn screening programs. 
Finally, even when States do detect an abnormal screening result, the 
majority do not inform parents directly.
  The legislation that we are introducing today will give states an 
additional helping hand toward meeting the advisory's committee's 
recommendation by providing $25 million for states to expand and 
improve their newborn screening programs. In order to access these 
resources, states will be required to commit to screening for all 29 
disorders.
  Our legislation will also authorize $15 million for two types of 
grants. The first seeks to address the lack of information available to 
health care professionals and parents about newborn screening. Every 
parent should have the knowledge necessary to protect their child. The 
tragedy of a newborn's death is only compounded by the frustration of 
learning that the death was preventable. This bill authorizes grants to 
provide education and training to health care professionals, state 
laboratory personnel, families and consumer advocates.
  The second type of grant will support States in providing follow-up 
care for those children diagnosed by a disorder detected through 
newborn screening. While these families are the fortunate ones, in many 
cases they are still faced with the prospect of extended and complex 
treatment and major lifestyle changes. We need to remember that care 
does not stop at diagnosis.
  To ensure the quality of laboratories involved in newborn screening, 
so that tests are as accurate as possible and infants receive 
appropriate care, the legislation authorizes $5 million for the Centers 
for Disease Control and Prevention, CDC, to carry out a number of 
functions such as quality assurance for newborn screening tests, 
performance evaluation services, and technical assistance and 
technology transfer to newborn screening labs.
  In the event of a public health emergency, such as Hurricane Katrina, 
newborn screening may seem like a low priority. However, if babies 
aren't tested and, when necessary, treated within the first few days of 
life, they may suffer irreparable harm or even death. In the wake of a 
public health crisis, contingency planning for newborn screening is 
essential. Our legislation requires the CDC, in consultation with the 
Health Resources and Services Administration, HRSA, to develop a 
national contingency plan for newborn screening in the event of a 
public health emergency within 180 days of enactment of the bill.
  Finally, the bill directs the CDC, in consultation with HRSA, to 
establish a national surveillance program for newborn screening, and 
authorizes $15 million for that purpose. Such a program will help us 
conduct research to better understand these rare disorders, and will 
hopefully lead us toward more effective treatments and cures.
  I urge my colleagues to support this important legislation so that 
every newborn child will have the best possible opportunity that 
America can offer to live a long, healthy and happy life. I look 
forward to working with the Chairman of the Health, Education, Labor 
and Pensions (HELP) Committee, Senator Kennedy, and Ranking Member Enzi 
to advance this legislation as early as possible.

[[Page S2083]]

  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                 S. 634

       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. 399AA. NEWBORN SCREENING.

       ``(a) Authorization of Grant Programs.--
       ``(1) Grants to assist health care professionals.--From 
     funds appropriated under subsection (h), the Secretary, 
     acting through the Associate Administrator of the Maternal 
     and Child Health Bureau of the Health Resources and Services 
     Administration (referred to in this section as the `Associate 
     Administrator') and in consultation with the Advisory 
     Committee on Heritable Disorders in Newborns and Children 
     (referred to in this section as the `Advisory Committee'), 
     shall award grants to eligible entities to enable such 
     entities to assist in providing health care professionals and 
     newborn screening laboratory personnel with--
       ``(A) education in newborn screening; and
       ``(B) training in--
       ``(i) relevant and new technologies in newborn screening; 
     and
       ``(ii) congenital, genetic, and metabolic disorders.
       ``(2) Grants to assist families.--
       ``(A) In general.--From funds appropriated under subsection 
     (h), the Secretary, acting through the Associate 
     Administrator and in consultation with the Advisory 
     Committee, shall award grants to eligible entities to enable 
     such entities to develop and deliver educational programs 
     about newborn screening to parents, families, and patient 
     advocacy and support groups. The educational materials 
     accompanying such educational programs shall be provided at 
     appropriate literacy levels.
       ``(B) Awareness of the availability of programs.--To the 
     extent practicable, the Secretary shall make relevant health 
     care providers aware of the availability of the educational 
     programs supported pursuant to subparagraph (A).
       ``(3) Grants for quality newborn screening followup.--From 
     funds appropriated under subsection (h), the Secretary, 
     acting through the Associate Administrator and in 
     consultation with the Advisory Committee, shall award grants 
     to eligible entities to enable such entities to establish, 
     maintain, and operate a system to assess and coordinate 
     treatment relating to congenital, genetic, and metabolic 
     disorders.
       ``(b) Application.--An eligible entity that desires to 
     receive a grant under this section shall submit an 
     application to the Secretary at such time, in such manner, 
     and accompanied by such information as the Secretary may 
     require.
       ``(c) Selection of Grant Recipients.--
       ``(1) In general.--Not later than 120 days after receiving 
     an application under subsection (b), the Secretary, after 
     considering the approval factors under paragraph (2), shall 
     determine whether to award the eligible entity a grant under 
     this section.
       ``(2) Approval factors.--
       ``(A) Requirements for approval.--An application submitted 
     under subsection (b) may not be approved by the Secretary 
     unless the application contains assurances that the eligible 
     entity--
       ``(i) will use grant funds only for the purposes specified 
     in the approved application and in accordance with the 
     requirements of this section; and
       ``(ii) will establish such fiscal control and fund 
     accounting procedures as may be necessary to assure proper 
     disbursement and accounting of Federal funds paid to the 
     eligible entity under the grant.
       ``(B) Existing programs.--Prior to awarding a grant under 
     this section, the Secretary shall--
       ``(i) conduct an assessment of existing educational 
     resources and training programs and coordinated systems of 
     followup care with respect to newborn screening; and
       ``(ii) take all necessary steps to minimize the duplication 
     of the resources and programs described in clause (i).
       ``(d) Coordination.--The Secretary shall take all necessary 
     steps to coordinate programs funded with grants received 
     under this section.
       ``(e) Use of Grant Funds.--
       ``(1) Grants to assist health care professionals.--An 
     eligible entity that receives a grant under subsection (a)(1) 
     may use the grant funds to work with appropriate medical 
     schools, nursing schools, schools of public health, schools 
     of genetic counseling, internal education programs in State 
     agencies, nongovernmental organizations, and professional 
     organizations and societies to develop and deliver education 
     and training programs that include--
       ``(A) continuing medical education programs for health care 
     professionals and newborn screening laboratory personnel in 
     newborn screening;
       ``(B) education, technical assistance, and training on new 
     discoveries in newborn screening and the use of any related 
     technology;
       ``(C) models to evaluate the prevalence of, and assess and 
     communicate the risks of, congenital conditions, including 
     the prevalence and risk of some of these conditions based on 
     family history;
       ``(D) models to communicate effectively with parents and 
     families about--
       ``(i) the process and benefits of newborn screening;
       ``(ii) how to use information gathered from newborn 
     screening;
       ``(iii) the meaning of screening results, including the 
     possibility of false positive findings;
       ``(iv) the right of refusal of newborn screening, if 
     applicable; and
       ``(v) the potential need for followup care after newborns 
     are screened;
       ``(E) information and resources on coordinated systems of 
     followup care after newborns are screened;
       ``(F) information on the disorders for which States require 
     and offer newborn screening and options for newborn screening 
     relating to conditions in addition to such disorders;
       ``(G) information on additional newborn screening that may 
     not be required by the State, but that may be available from 
     other sources; and
       ``(H) other items to carry out the purpose described in 
     subsection (a)(1) as determined appropriate by the Secretary.
       ``(2) Grants to assist families.--An eligible entity that 
     receives a grant under subsection (a)(2) may use the grant 
     funds to develop and deliver to parents, families, and 
     patient advocacy and support groups, educational programs 
     about newborn screening that include information on--
       ``(A) what newborn screening is;
       ``(B) how newborn screening is performed;
       ``(C) who performs newborn screening;
       ``(D) where newborn screening is performed;
       ``(E) the disorders for which the State requires newborns 
     to be screened;
       ``(F) different options for newborn screening for disorders 
     other than those included by the State in the mandated 
     newborn screening program;
       ``(G) the meaning of various screening results, including 
     the possibility of false positive and false negative 
     findings;
       ``(H) the prevalence and risk of newborn disorders, 
     including the increased risk of disorders that may stem from 
     family history;
       ``(I) coordinated systems of followup care after newborns 
     are screened; and
       ``(J) other items to carry out the purpose described in 
     subsection (a)(2) as determined appropriate by the Secretary.
       ``(3) Grants for quality newborn screening followup.--An 
     eligible entity that receives a grant under subsection (a)(3) 
     shall use the grant funds to--
       ``(A) expand on existing procedures and systems, where 
     appropriate and available, for the timely reporting of 
     newborn screening results to individuals, families, primary 
     care physicians, and subspecialists in congenital, genetic, 
     and metabolic disorders;
       ``(B) coordinate ongoing followup treatment with 
     individuals, families, primary care physicians, and 
     subspecialists in congenital, genetic, and metabolic 
     disorders after a newborn receives an indication of the 
     presence or increased risk of a disorder on a screening test;
       ``(C) ensure the seamless integration of confirmatory 
     testing, tertiary care medical services, comprehensive 
     genetic services including genetic counseling, and 
     information about access to developing therapies by 
     participation in approved clinical trials involving the 
     primary health care of the infant;
       ``(D) analyze data, if appropriate and available, collected 
     from newborn screenings to identify populations at risk for 
     disorders affecting newborns, examine and respond to

[[Page S2084]]

     health concerns, recognize and address relevant 
     environmental, behavioral, socioeconomic, demographic, and 
     other relevant risk factors; and
       ``(E) carry out such other activities as the Secretary may 
     determine necessary.
       ``(f) Reports to Congress.--
       ``(1) In general.--Subject to paragraph (2), the Secretary 
     shall submit to the appropriate committees of Congress 
     reports--
       ``(A) evaluating the effectiveness and the impact of the 
     grants awarded under this section--
       ``(i) in promoting newborn screening--

       ``(I) education and resources for families; and
       ``(II) education, resources, and training for health care 
     professionals;

       ``(ii) on the successful diagnosis and treatment of 
     congenital, genetic, and metabolic disorders; and
       ``(iii) on the continued development of coordinated systems 
     of followup care after newborns are screened;
       ``(B) describing and evaluating the effectiveness of the 
     activities carried out with grant funds received under this 
     section; and
       ``(C) that include recommendations for Federal actions to 
     support--
       ``(i) education and training in newborn screening; and
       ``(ii) followup care after newborns are screened.
       ``(2) Timing of reports.--The Secretary shall submit--
       ``(A) an interim report that includes the information 
     described in paragraph (1), not later than 30 months after 
     the date on which the first grant funds are awarded under 
     this section; and
       ``(B) a subsequent report that includes the information 
     described in paragraph (1), not later than 60 months after 
     the date on which the first grant funds are awarded under 
     this section.
       ``(g) Definition of Eligible Entity.--In this section, the 
     term `eligible entity' means--
       ``(1) a State or a political subdivision of a State;
       ``(2) a consortium of 2 or more States or political 
     subdivisions of States;
       ``(3) a territory;
       ``(4) an Indian tribe or a hospital or outpatient health 
     care facility of the Indian Health Service; or
       ``(5) a nongovernmental organization with appropriate 
     expertise in newborn screening, as determined by the 
     Secretary.
       ``(h) National Contingency Plan for Newborn Screening.--
       ``(1) 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 Associate 
     Administrator, shall develop a national contingency plan for 
     newborn screening for use in the event of a public health 
     emergency.
       ``(2) Requirements.--The contingency plan developed under 
     paragraph (1) shall include a plan for--
       ``(A) the collection and transport of specimens;
       ``(B) the shipment of specimens to State newborn screening 
     laboratories;
       ``(C) the processing of specimens;
       ``(D) the reporting of screening results to physicians and 
     families;
       ``(E) the diagnostic confirmation of positive screening 
     results;
       ``(F) ensuring the availability of treatment and management 
     resources;
       ``(G) educating families about newborn screening; and
       ``(H) carrying out other activities determined appropriate 
     by the Secretary.
       ``(i) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section--
       ``(1) $15,000,000 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 
     ``$25,000,000 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) by redesignating paragraph (3) as paragraph (5);
       (B) in paragraph (2), by striking ``and'' after the 
     semicolon;
       (C) by inserting after paragraph (2) the following:
       ``(3) recommend a uniform screening panel for newborn 
     screening programs that includes the heritable disorders for 
     which all newborns should be screened, including secondary 
     conditions that may be identified as a result of the 
     laboratory methods used for screening;
       ``(4) develop a model decision-matrix for newborn screening 
     program expansion, and periodically update the recommended 
     uniform screening panel described in paragraph (3) based on 
     such decision-matrix; and''; and
       (D) in paragraph (5) (as redesignated by subparagraph (A)), 
     by striking the period at the end and inserting ``, including 
     recommendations, advice, or information dealing with--
       ``(A) followup activities, including those necessary to 
     achieve rapid diagnosis in the short term, and those that 
     ascertain long-term case management outcomes and appropriate 
     access to related services;
       ``(B) diagnostic and other technology used in screening;
       ``(C) the availability and reporting of testing for 
     conditions for which there is no existing treatment;
       ``(D) minimum standards and related policies and procedures 
     for State newborn screening programs;
       ``(E) quality assurance, oversight, and evaluation of State 
     newborn screening programs;
       ``(F) data collection for assessment of newborn screening 
     programs;
       ``(G) public and provider awareness and education;
       ``(H) language and terminology used by State newborn 
     screening programs;
       ``(I) confirmatory testing and verification of positive 
     results; and
       ``(J) harmonization of laboratory definitions for results 
     that are within the expected range and results that are 
     outside of the expected range.''; and
       (2) by adding at the end the following:
       ``(d) Decision on Recommendations.--
       ``(1) In general.--Not later than 180 days after the 
     Advisory Committee issues a recommendation pursuant to this 
     section, the Secretary shall adopt or reject such 
     recommendation.
       ``(2) Pending recommendations.--The Secretary shall adopt 
     or reject any recommendation issued by the Advisory Committee 
     that is pending on the date of enactment of the Newborn 
     Screening Saves Lives Act of 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) 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.''.

     SEC. 7. LABORATORY QUALITY AND SURVEILLANCE.

       Part A of title XI of the Public Health Service Act (42 
     U.S.C. 300b-1 et seq.) is amended by adding at the end the 
     following:

     ``SEC. 1112. LABORATORY QUALITY.

       ``(a) In General.--The Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention 
     and in consultation with the Advisory Committee on Heritable 
     Disorders in Newborns and Children established under section 
     1111, shall provide for--
       ``(1) quality assurance for laboratories involved in 
     screening newborns and children for heritable disorders, 
     including quality assurance for newborn-screening tests, 
     performance evaluation services, and technical assistance and 
     technology transfer to newborn screening laboratories to 
     ensure analytic validity and utility of screening tests; and
       ``(2) population-based pilot testing for new screening 
     tools for evaluating use on a mass scale.
       ``(b) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated $5,000,000 for fiscal year 2008 and such sums as 
     may be necessary for each of the fiscal years 2009 through 
     2012.

     ``SEC. 1113. SURVEILLANCE PROGRAMS FOR HERITABLE DISORDERS 
                   SCREENING.

       ``(a) In General.--The Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention, 
     in consultation with the Associate Administrator of the 
     Maternal and Child Health Bureau of the Health Resources and 
     Services Administration, shall carry out programs--

[[Page S2085]]

       ``(1) to collect, analyze, and make available data on the 
     heritable disorders recommended by the Advisory Committee on 
     Heritable Disorders in Newborns and Children established 
     under section 1111, including data on the causes of such 
     disorders and on the incidence and prevalence of such 
     disorders;
       ``(2) to operate regional centers for the conduct of 
     applied epidemiological research on the prevention of such 
     disorders;
       ``(3) to provide information and education to the public on 
     the prevention of such disorders; and
       ``(4) to conduct research on and to promote the prevention 
     of such disorders, and secondary health conditions among 
     individuals with such disorders.
       ``(b) Grants and Contracts.--
       ``(1) In general.--In carrying out subsection (a), the 
     Secretary may make grants to and enter into contracts with 
     public and nonprofit private entities.
       ``(2) Supplies and services in lieu of award funds.--
       ``(A) In general.--Upon the request of a recipient of an 
     award of a grant or contract under paragraph (1), the 
     Secretary may, subject to subparagraph (B), provide supplies, 
     equipment, and services for the purpose of aiding the 
     recipient in carrying out the purposes for which the award is 
     made and, for such purposes, may detail to the recipient any 
     officer or employee of the Department of Health and Human 
     Services.
       ``(B) Reduction.--With respect to a request described in 
     subparagraph (A), the Secretary shall reduce the amount of 
     payments under the award involved by an amount equal to the 
     costs of detailing personnel and the fair market value of any 
     supplies, equipment, or services provided by the Secretary. 
     The Secretary shall, for the payment of expenses incurred in 
     complying with such request, expend the amounts withheld.
       ``(3) Application for award.--The Secretary may make an 
     award of a grant or contract under paragraph (1) only if an 
     application for the award is submitted to the Secretary and 
     the application is in such form, is made in such manner, and 
     contains such agreements, assurances, and information as the 
     Secretary determines to be necessary to carry out the 
     purposes for which the award is to be made.
       ``(c) Biennial Report.--Not later than February 1 of fiscal 
     year 2008 and of every second such year thereafter, the 
     Secretary shall submit to the Committee on Energy and 
     Commerce of the House of Representatives, and the Committee 
     on Health, Education, Labor, and Pensions of the Senate, a 
     report that, with respect to the preceding 2 fiscal years--
       ``(1) contains information regarding the incidence and 
     prevalence of heritable disorders and the health status of 
     individuals with such disorders and the extent to which such 
     disorders have contributed to the incidence and prevalence of 
     infant mortality and affected quality of life;
       ``(2) contains information under paragraph (1) that is 
     specific to various racial and ethnic groups (including 
     Hispanics, non-Hispanic whites, Blacks, Native Americans, and 
     Asian Americans);
       ``(3) contains an assessment of the extent to which various 
     approaches of preventing heritable disorders and secondary 
     health conditions among individuals with such disorders have 
     been effective;
       ``(4) describes the activities carried out under this 
     section;
       ``(5) contains information on the incidence and prevalence 
     of individuals living with heritable disorders, information 
     on the health status of individuals with such disorders, 
     information on any health disparities experienced by such 
     individuals, and recommendations for improving the health and 
     wellness and quality of life of such individuals;
       ``(6) contains a summary of recommendations from all 
     heritable disorders research conferences sponsored by the 
     Centers for Disease Control and Prevention; and
       ``(7) contains any recommendations of the Secretary 
     regarding this section.
       ``(d) Applicability of Privacy Laws.--The provisions of 
     this section shall be subject to the requirements of section 
     552a of title 5, United States Code. All Federal laws 
     relating to the privacy of information shall apply to the 
     data and information that is collected under this section.
       ``(e) Coordination.--
       ``(1) In general.--In carrying out this section, the 
     Secretary shall coordinate, to the extent practicable, 
     programs under this section with programs on birth defects 
     and developmental disabilities authorized under section 317C.
       ``(2) Priority in grants and contracts.--In making grants 
     and contracts under this section, the Secretary shall give 
     priority to entities that demonstrate the ability to 
     coordinate activities under a grant or contract made under 
     this section with existing birth defects surveillance 
     activities.
       ``(f) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated $15,000,000 for fiscal year 2008 and such sums 
     as may be necessary for each of the fiscal years 2009 through 
     2012.''.

  Mr. HATCH. I am pleased to introduce today, along with my colleague 
Senator Christopher Dodd, the Newborn Screening Saves Lives Act of 
2007.
  Every State and U.S. territory routinely screens newborns for certain 
genetic, metabolic, hormonal and functional disorders. Most of these 
birth defects have no immediate visible effects on a baby but, unless 
detected and treated early, can cause physical problems, mental 
retardation and, in some cases, death.
  Babies who have these diseases and babies who do not have these 
diseases look the same at birth. Fortunately, most babies are given a 
clean bill of health when tested. In cases where babies are found to 
have metabolic disorders or hearing impairment, early diagnosis and 
proper treatment can make the difference between healthy development 
and lifelong impairment.
  Except for hearing screening, all newborn screening tests are done 
using a few drops of blood from the newborn's heel. Newborn screening 
checks for diseases that can cause problems with the way the body gets 
energy, how the body makes hormones, or how the body makes blood cells.
  Currently each state or region operates by law its own newborn 
screening program. Individual programs vary widely in the number and 
types of conditions for which they test. According to the National 
Newborn Screening and Genetics Resources Center, some States test for 
as few as four disorders, while others test for 30 or more.
  Disparities among States in screening tests given at birth result in 
too many babies with serious birth defects not being diagnosed and 
treated in time to avoid death or long term disability. Many States 
offer only limited educational materials for parents and health care 
providers about the availability of newborn screening tests; therefore 
parents are often unaware of the importance of testing and may learn 
too late that their newborn has an abnormal metabolic condition which 
could have been treated.
  In 2004, the American College of Medical Genetics 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 disorders, including certain metabolic conditions and hearing 
deficiency. Currently, only 11 States and the District of Columbia 
require the recommended screening for all 29 disorders.
  Last year there was much success in improving newborn screening in my 
home State of Utah, which increased testing from 4 to 36 disorders. The 
expansion of newborn screening is a major advancement for children's 
healthcare in Utah, as the screening should identify an additional 15 
to 20 Utah infants every year in time to help them get the treatment 
they need to live a fuller and healthier life.
  Enactment of the Newborn Screening Saves Lives Act would provide 
necessary resource materials to educate parents and health providers 
about newborn screening and help states expand and improve their 
newborn screening programs. Other important provisions of this 
legislation help ensure the quality of laboratories involved in newborn 
screening and call for establishing a system for collecting and 
analyzing data from newborn screening programs.
  The bill will establish grant programs to provide for education and 
outreach on newborn screening and coordinated follow-up care once 
newborn screening has been conducted. It will help States expand and 
improve their newborn screening programs, educate parents and providers 
and improve follow-up care for infants. The bill also contains 
provisions for a contingency plan for newborn screening in the case of 
a national public health emergency, such as that which was witnessed in 
the wake of Hurricanes Katrina and Rita.
  The Newborn Screening Saves Lives Act of 2007 is endorsed by the 
March of Dimes, the American Academy of Pediatrics, Easter Seals, and 
the American Public Health Labs. These groups recognize that expanded 
newborn screening will help pediatricians and other healthcare 
providers identify rare disorders than can be easily confused with 
common pediatric problems. Diagnosing and treating these conditions 
will help prevent irreversible brain damage, permanent disabilities, 
and possibly death. I urge my colleagues to take a stand for newborn 
health and support this bill.
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