II 109th CONGRESS 2d Session S. 2663 IN THE SENATE OF THE UNITED STATES April 27, 2006 Mr. Dodd (for himself and Mr. DeWine) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Public Health Service Act to establish grant programs to provide for education and outreach on newborn screening and coordinated followup care once newborn screening has been conducted, to reauthorize programs under part A of title XI of such Act, and for other purposes.

1.

Short title

This Act may be cited as the Newborn Screening Saves Lives Act of 2006.

2.

Findings

Congress finds the following: (1)Currently, it is possible to test for more than 30 disorders through newborn screening. (2)There is a lack of uniform newborn screening throughout the United States. While a newborn with a debilitating condition may receive screening, early detection, and treatment in 1 location, in another location the condition may go undetected and result in catastrophic consequences. (3)Each year more than 4,000,000 babies are screened by State and private laboratories to detect conditions that may threaten their long-term health. (4)There are more than 2,000 babies born every year in the United States with detectable and treatable disorders that go unscreened through newborn screening.

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:

399AA.

Newborn screening

(a)

Authorization of grant programs

(1)

Grants to assist health care professionals

From funds appropriated under subsection (h), the Secretary, acting through the Associate Administrator of the Maternal and Child Health Bureau of the Health Resources and Services Administration (referred to in this section as the Associate Administrator) and in consultation with the Advisory Committee on Heritable Disorders in Newborns and Children (referred to in this section as the Advisory Committee), shall award grants to eligible entities to enable such entities to assist in providing health care professionals and newborn screening laboratory personnel with— (A)education in newborn screening; and (B)training in— (i)relevant and new technologies in newborn screening; and (ii)congenital, genetic, and metabolic disorders. (2)

Grants to assist families

(A)

In general

From funds appropriated under subsection (h), the Secretary, acting through the Associate Administrator and in consultation with the Advisory Committee, shall award grants to eligible entities to enable such entities to develop and deliver educational programs about newborn screening to parents, families, and patient advocacy and support groups. The educational materials accompanying such educational programs shall be provided at appropriate literacy levels. (B)

Awareness of the availability of programs

To the extent practicable, the Secretary shall make relevant health care providers aware of the availability of the educational programs supported pursuant to subparagraph (A). (3)

Grants for quality newborn screening followup

From funds appropriated under subsection (h), the Secretary, acting through the Associate Administrator and in consultation with the Advisory Committee, shall award grants to eligible entities to enable such entities to establish, maintain, and operate a system to assess and coordinate treatment relating to congenital, genetic, and metabolic disorders. (b)

Application

An eligible entity that desires to receive a grant under this section shall submit an application to the Secretary at such time, in such manner, and accompanied by such information as the Secretary may require. (c)

Selection of grant recipients

(1)

In general

Not later than 120 days after receiving an application under subsection (b), the Secretary, after considering the approval factors under paragraph (2), shall determine whether to award the eligible entity a grant under this section. (2)

Approval factors

(A)

Requirements for approval

An application submitted under subsection (b) may not be approved by the Secretary unless the application contains assurances that the eligible entity— (i)will use grant funds only for the purposes specified in the approved application and in accordance with the requirements of this section; and (ii)will establish such fiscal control and fund accounting procedures as may be necessary to assure proper disbursement and accounting of Federal funds paid to the eligible entity under the grant. (B)

Existing programs

Prior to awarding a grant under this section, the Secretary shall— (i)conduct an assessment of existing educational resources and training programs and coordinated systems of followup care with respect to newborn screening; and (ii)take all necessary steps to minimize the duplication of the resources and programs described in clause (i). (d)

Coordination

The Secretary shall take all necessary steps to coordinate programs funded with grants received under this section. (e)

Use of grant funds

(1)

Grants to assist health care professionals

An eligible entity that receives a grant under subsection (a)(1) may use the grant funds to work with appropriate medical schools, nursing schools, schools of public health, schools of genetic counseling, internal education programs in State agencies, nongovernmental organizations, and professional organizations and societies to develop and deliver education and training programs that include— (A)continuing medical education programs for health care professionals and newborn screening laboratory personnel in newborn screening; (B)education, technical assistance, and training on new discoveries in newborn screening and the use of any related technology; (C)models to evaluate the prevalence of, and assess and communicate the risks of, congenital conditions, including the prevalence and risk of some of these conditions based on family history; (D)models to communicate effectively with parents and families about— (i)the process and benefits of newborn screening; (ii)how to use information gathered from newborn screening; (iii)the meaning of screening results, including the possibility of false positive findings; (iv)the right of refusal of newborn screening, if applicable; and (v)the potential need for followup care after newborns are screened; (E)information and resources on coordinated systems of followup care after newborns are screened; (F)information on the disorders for which States require and offer newborn screening and options for newborn screening relating to conditions in addition to such disorders; (G)information on additional newborn screening that may not be required by the State, but that may be available from other sources; and (H)other items to carry out the purpose described in subsection (a)(1) as determined appropriate by the Secretary. (2)

Grants to assist families

An eligible entity that receives a grant under subsection (a)(2) may use the grant funds to develop and deliver to parents, families, and patient advocacy and support groups, educational programs about newborn screening that include information on— (A)what newborn screening is; (B)how newborn screening is performed; (C)who performs newborn screening; (D)where newborn screening is performed; (E)the disorders for which the State requires newborns to be screened; (F)different options for newborn screening for disorders other than those included by the State in the mandated newborn screening program; (G)the meaning of various screening results, including the possibility of false positive and false negative findings; (H)the prevalence and risk of newborn disorders, including the increased risk of disorders that may stem from family history; (I)coordinated systems of followup care after newborns are screened; and (J)other items to carry out the purpose described in subsection (a)(2) as determined appropriate by the Secretary. (3)

Grants for quality newborn screening followup

An eligible entity that receives a grant under subsection (a)(3) shall use the grant funds to— (A)expand on existing procedures and systems, where appropriate and available, for the timely reporting of newborn screening results to individuals, families, primary care physicians, and subspecialists in congenital, genetic, and metabolic disorders; (B)coordinate ongoing followup treatment with individuals, families, primary care physicians, and subspecialists in congenital, genetic, and metabolic disorders after a newborn receives an indication of the presence or increased risk of a disorder on a screening test; (C)ensure the seamless integration of confirmatory testing, tertiary care medical services, comprehensive genetic services including genetic counseling, and information about access to developing therapies by participation in approved clinical trials involving the primary health care of the infant; (D)analyze data, if appropriate and available, collected from newborn screenings to identify populations at risk for disorders affecting newborns, examine and respond to health concerns, recognize and address relevant environmental, behavioral, socioeconomic, demographic, and other relevant risk factors; and (E)carry out such other activities as the Secretary may determine necessary. (f)

Reports to Congress

(1)

In general

Subject to paragraph (2), the Secretary shall submit to the appropriate committees of Congress reports— (A)evaluating the effectiveness and the impact of the grants awarded under this section— (i)in promoting newborn screening— (I)education and resources for families; and (II)education, resources, and training for health care professionals; (ii)on the successful diagnosis and treatment of congenital, genetic, and metabolic disorders; and (iii)on the continued development of coordinated systems of followup care after newborns are screened; (B)describing and evaluating the effectiveness of the activities carried out with grant funds received under this section; and (C)that include recommendations for Federal actions to support— (i)education and training in newborn screening; and (ii)followup care after newborns are screened. (2)

Timing of reports

The Secretary shall submit— (A)an interim report that includes the information described in paragraph (1), not later than 30 months after the date on which the first grant funds are awarded under this section; and (B)a subsequent report that includes the information described in paragraph (1), not later than 60 months after the date on which the first grant funds are awarded under this section. (g)

Definition of eligible entity

In this section, the term eligible entity means— (1)a State or a political subdivision of a State; (2)a consortium of 2 or more States or political subdivisions of States; (3)a territory; (4)an Indian tribe or a hospital or outpatient health care facility of the Indian Health Service; or (5)a nongovernmental organization with appropriate expertise in newborn screening, as determined by the Secretary. (h)

Authorization of appropriations

There are authorized to be appropriated to carry out this section— (1)$15,000,000 for fiscal year 2007; and (2)such sums as may be necessary for each of fiscal years 2008 through 2011.

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4.

Improved newborn and child screening for heritable disorders

Section 1109 of the Public Health Service Act (42 U.S.C. 300b–8) is amended— (1)in subsection (c)(2)— (A)in subparagraph (E), by striking and after the semicolon; (B)by redesignating subparagraph (F) as subparagraph (G); and (C)by inserting after subparagraph (E) the following: (F)an assurance that the entity has adopted and implemented, is in the process of adopting and implementing, or will use grant amounts received under this section to adopt and implement the guidelines and recommendations of the Advisory Committee on Heritable Disorders in Newborns and Children established under section 1111 (referred to in this section as the Advisory Committee) that are adopted by the Secretary and in effect at the time the grant is awarded or renewed under this section, which shall include the screening of each newborn for the heritable disorders recommended by the Advisory Committee and adopted by the Secretary and the reporting of results; and ; and (2)in subsection (i), by striking such sums and all that follows through the period at the end and inserting $25,000,000 for fiscal year 2007 and such sums as may be necessary for each of the fiscal years 2008 through 2011..

5.

Evaluating the effectiveness of newborn- and child-screening programs

Section 1110 of the Public Health Service Act (42 U.S.C. 300b–9) is amended by adding at the end the following: (d)

Authorization of appropriations

There are authorized to be appropriated to carry out this section $5,000,000 for fiscal year 2007 and such sums as may be necessary for each of the fiscal years 2008 through 2011. .

6.

Advisory committee on heritable disorders in newborns and children

Section 1111 of the Public Health Service Act (42 U.S.C. 300b–10) is amended— (1)in subsection (b)— (A)by redesignating paragraph (3) as paragraph (5); (B)in paragraph (2), by striking and after the semicolon; (C)by inserting after paragraph (2) the following: (3)recommend a uniform screening panel for newborn screening programs that includes the heritable disorders for which all newborns should be screened, including secondary conditions that may be identified as a result of the laboratory methods used for screening; (4)develop a model decision-matrix for newborn screening program expansion, and periodically update the recommended uniform screening panel described in paragraph (3) based on such decision-matrix; and ; and (D)in paragraph (5) (as redesignated by subparagraph (A)), by striking the period at the end and inserting , including recommendations, advice, or information dealing with—(A)followup activities, including those necessary to achieve rapid diagnosis in the short term, and those that ascertain long-term case management outcomes and appropriate access to related services; (B)diagnostic and other technology used in screening; (C)the availability and reporting of testing for conditions for which there is no existing treatment; (D)minimum standards and related policies and procedures for State newborn screening programs; (E)quality assurance, oversight, and evaluation of State newborn screening programs; (F)data collection for assessment of newborn screening programs; (G)public and provider awareness and education; (H)language and terminology used by State newborn screening programs; (I)confirmatory testing and verification of positive results; and (J)harmonization of laboratory definitions for results that are within the expected range and results that are outside of the expected range. ; and (2)by adding at the end the following: (d)

Decision on recommendations

(1)

In general

Not later than 180 days after the Advisory Committee issues a recommendation pursuant to this section, the Secretary shall adopt or reject such recommendation. (2)

Pending recommendations

The Secretary shall adopt or reject any recommendation issued by the Advisory Committee that is pending on the date of enactment of the Newborn Screening Saves Lives Act of 2006 by not later than 180 days after the date of enactment of such Act. (3)

Determinations to be made public

The Secretary shall publicize any determination on adopting or rejecting a recommendation of the Advisory Committee pursuant to this subsection, including the justification for the determination. (e)

Continuation of operation of committee

Notwithstanding section 14 of the Federal Advisory Committee Act (5 U.S.C. App.), the Advisory Committee shall continue to operate during the 5-year period beginning on the date of enactment of the Newborn Screening Saves Lives Act of 2006. .

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:

1112.

Laboratory quality

(a)

In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in consultation with the Advisory Committee on Heritable Disorders in Newborns and Children established under section 1111, shall provide for— (1)quality assurance for laboratories involved in screening newborns and children for heritable disorders, including quality assurance for newborn-screening tests, performance evaluation services, and technical assistance and technology transfer to newborn screening laboratories to ensure analytic validity and utility of screening tests; and (2)population-based pilot testing for new screening tools for evaluating use on a mass scale. (b)

Authorization of appropriations

For the purpose of carrying out this section, there are authorized to be appropriated $5,000,000 for fiscal year 2007 and such sums as may be necessary for each of the fiscal years 2008 through 2011.

1113.

Surveillance programs for heritable disorders screening

(a)

In general

The Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall carry out programs— (1)to collect, analyze, and make available data on the heritable disorders recommended by the Advisory Committee on Heritable Disorders in Newborns and Children established under section 1111, including data on the causes of such disorders and on the incidence and prevalence of such disorders; (2)to operate regional centers for the conduct of applied epidemiological research on the prevention of such disorders; (3)to provide information and education to the public on the prevention of such disorders; and (4)to conduct research on and to promote the prevention of such disorders, and secondary health conditions among individuals with such disorders. (b)

Grants and Contracts

(1)

In general

In carrying out subsection (a), the Secretary may make grants to and enter into contracts with public and nonprofit private entities. (2)

Supplies and services in lieu of award funds

(A)

In general

Upon the request of a recipient of an award of a grant or contract under paragraph (1), the Secretary may, subject to subparagraph (B), provide supplies, equipment, and services for the purpose of aiding the recipient in carrying out the purposes for which the award is made and, for such purposes, may detail to the recipient any officer or employee of the Department of Health and Human Services. (B)

Reduction

With respect to a request described in subparagraph (A), the Secretary shall reduce the amount of payments under the award involved by an amount equal to the costs of detailing personnel and the fair market value of any supplies, equipment, or services provided by the Secretary. The Secretary shall, for the payment of expenses incurred in complying with such request, expend the amounts withheld. (3)

Application for award

The Secretary may make an award of a grant or contract under paragraph (1) only if an application for the award is submitted to the Secretary and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Secretary determines to be necessary to carry out the purposes for which the award is to be made. (c)

Biennial Report

Not later than February 1 of fiscal year 2007 and of every second such year thereafter, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate, a report that, with respect to the preceding 2 fiscal years— (1)contains information regarding the incidence and prevalence of heritable disorders and the health status of individuals with such disorders and the extent to which such disorders have contributed to the incidence and prevalence of infant mortality and affected quality of life; (2)contains information under paragraph (1) that is specific to various racial and ethnic groups (including Hispanics, non-Hispanic whites, Blacks, Native Americans, and Asian Americans); (3)contains an assessment of the extent to which various approaches of preventing heritable disorders and secondary health conditions among individuals with such disorders have been effective; (4)describes the activities carried out under this section; (5)contains information on the incidence and prevalence of individuals living with heritable disorders, information on the health status of individuals with such disorders, information on any health disparities experienced by such individuals, and recommendations for improving the health and wellness and quality of life of such individuals; (6)contains a summary of recommendations from all heritable disorders research conferences sponsored by the Centers for Disease Control and Prevention; and (7)contains any recommendations of the Secretary regarding this section. (d)

Applicability of Privacy Laws

The provisions of this section shall be subject to the requirements of section 552a of title 5, United States Code. All Federal laws relating to the privacy of information shall apply to the data and information that is collected under this section. (e)

Coordination

(1)

In general

In carrying out this section, the Secretary shall coordinate, to the extent practicable, programs under this section with programs on birth defects and developmental disabilities authorized under section 317C. (2)

Priority in grants and contracts

In making grants and contracts under this section, the Secretary shall give priority to entities that demonstrate the ability to coordinate activities under a grant or contract made under this section with existing birth defects surveillance activities. (f)

Authorization of Appropriations

For the purpose of carrying out this section, there are authorized to be appropriated $15,000,000 for fiscal year 2007 and such sums as may be necessary for each of the fiscal years 2008 through 2011.

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