I 108th CONGRESS 2d Session H. R. 4493 IN THE HOUSE OF REPRESENTATIVES June 2, 2004 Ms. Roybal-Allard (for herself, Mr. Simpson, Mr. Serrano, Mr. Kildee, Mr. Gordon, Mr. Andrews, Mr. Green of Texas, Mr. Walsh, Mr. Wexler, Mr. Meehan, Mr. Cunningham, and Mr. Schiff) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Public Health Service Act to establish grant programs to provide for education and outreach on newborn screening and coordinated followup care once newborn screening has been conducted, and for other purposes.

1.

Short title

This Act may be cited as the Newborn Screening Saves Lives Act of 2004.

2.

Findings

Congress finds the following: (1)Currently, it is possible to test for at least 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 one 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 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 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 State health department 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

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. (3)

Grants for 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, 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 State health department 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 what a newborn should be screened for and when and where that screening should take place; (D)models to evaluate the prevalence of, and assess and communicate the risks of, newborn disorders, including the prevalence and risk of certain newborn disorders based on family history; (E)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 rate of false positives; (iv)the right of refusal of newborn screening; and (v)the potential need for followup care after newborns are screened; (F)information and resources on coordinated systems of followup care after newborns are screened; (G)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; (H)information on supplemental newborn screening that the States do not require and offer but that parents may want; and (I)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 is newborn screening; (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 rate of false positives; (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 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 2005; and (2)such sums as may be necessary for each of fiscal years 2006 through 2009.

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